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1

Veling, J., F. G. van Zijderveld, A. M. van Zijderveld-van Bemmel, H. W. Barkema, and Y. H. Schukken. "Evaluation of Three Newly Developed Enzyme-Linked Immunosorbent Assays and Two Agglutination Tests for Detecting Salmonella enterica subsp. enterica Serovar Dublin Infections in Dairy Cattle." Journal of Clinical Microbiology 38, no. 12 (2000): 4402–7. http://dx.doi.org/10.1128/jcm.38.12.4402-4407.2000.

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In this study test characteristics of three newly developed enzyme-linked immunosorbent assays (ELISAs) for Salmonella enterica subsp. enterica serovar Dublin were evaluated and compared with two agglutination tests. The ELISAs involved were an indirect ELISA with serovar Dublin lipopolysaccharide (LPS ELISA), an indirect ELISA with serovar Dublin flagellar antigen (GP ELISA), and a double-antibody sandwich blocking ELISA that uses monoclonal antibodies against S. enterica subsp.enterica serovar Enteritidis flagellin (GM-DAS ELISA). The agglutination tests involved were two routine serum agglutination tests with either somatic (O) or flagellar (H) antigen. Diagnostic specificity of the three ELISAs was determined using 840 serum samples from seven dairy herds without any history of serovar Dublin infection. Cutoff values at a titer of 100, 100, and 10, respectively, for the LPS ELISA, GP ELISA, and GM-DAS blocking ELISA resulted in a specificity of 99.3, 100, and 100%, respectively. Using these cutoff values the LPS ELISA, GP ELISA, and GM-DAS ELISA were able to detect, respectively, 30, 46, and 38% of 50 fecal culture-positive animals from 13 herds with a recent serovar Dublin infection. With the same cutoff values, active carriers (n = 18) were detected for 94.4% with the LPS ELISA and for 100% with the GP and GM-DAS ELISAs. Kappa values determined on the results of all tests from 8 of the 13 serovar Dublin-infected herds and the 7 control herds demonstrated a good correlation between the results of all ELISAs and the H-agglutination test. The results of the O-agglutination test failed to correlate with those of the other tests. Using a set of sera from 170 aborting cows (with 25 abortions due to serovar Dublin), test results of the ELISAs and the H-agglutination test were comparable. The H-agglutination test may be used successfully for single sample testing, especially to diagnose abortion due to serovar Dublin. It is concluded that the ELISAs are useful diagnostic tools in serovar Dublin control programs and that they are preferred to agglutination tests for reasons of automation and costs.
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2

Şener, Burçin. "ANCA Tests (IFA and ELISA)." Acta Medica 52 (April 30, 2021): 11. http://dx.doi.org/10.32552/2021.actamedica.597.

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3

Halperin, Gideon. "Accuracy validation in ELISA tests." Biologicals 31, no. 3 (September 2003): 231. http://dx.doi.org/10.1016/s1045-1056(03)00039-3.

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4

Arnout, J., E. Huybrechts, M. Vanrusselt, C. Falcon, and J. Vermylen. "Detection of Lupus-Like Anticoagulants by an Enzyme-Linked Immunosorbent Assay Using a Partial Thromboplastin as Antigen; A Comparative Study." Thrombosis and Haemostasis 64, no. 01 (1990): 026–31. http://dx.doi.org/10.1055/s-0038-1647148.

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SummaryClotting assays allow qualitative rather than quantitative detection of the lupus anticoagulant. We have therefore studied the usefulness of an ELISA using a commercial partial thromboplastin, Thrombofax, oS antigen; the results obtained on 146 selected patient plasmas were compared to the results of coagulation tests (kaolin clotting time, tissue thromboplastin inhibition test, activated partial thromboplastin time) and of ELISAs using cardiolipin or phosphatidylserine as antigen. While satisfactory agreement was found within the group of coagulation tests or that of ELISAs, only a moderate agreement was obtained between clotting tests and ELISAs, the best being with the partial thromboplastin ELISA using low plasma dilutions. The study further indicates that ELISA techniques cannot entirely replace coagulation tests for the detection of a lupus anticoagulant, even when a partial thromboplastin is used as antigen. On the other hand, coagulation tests are less sensitive than ELISAs for the detection of antiphospholipid antibodies.
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5

MIKHAILOVA, V. V., T. P. LOBOVA, A. N. SKVORTSOVA, and M. S. SHISHKINA. "PRRS: COMPARATIVE TESTS OF ELISA TESTS FOR OBJECTIVE DISGNOSTICS." PIG-BREEDING, no. 5 (2020): 26–28. http://dx.doi.org/10.37925/0039-713x-2020-5-26-28.

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6

Collins, Michael T., Scott J. Wells, Kristine R. Petrini, James E. Collins, Ronald D. Schultz, and Robert H. Whitlock. "Evaluation of Five Antibody Detection Tests for Diagnosis of Bovine Paratuberculosis." Clinical Diagnostic Laboratory Immunology 12, no. 6 (June 2005): 685–92. http://dx.doi.org/10.1128/cdli.12.6.685-692.2005.

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ABSTRACT Five diagnostic tests based on enzyme-linked immunosorbent assay (ELISA) technology for bovine paratuberculosis were evaluated by using individual serum or milk samples from 359 dairy cattle in seven paratuberculosis-free herds and 2,094 dairy cattle in seven Mycobacterium paratuberculosis-infected dairy herds. Three independent laboratories using three different culture procedures completed fecal cultures for M. paratuberculosis on these cattle and found 417 cows to be shedding M. paratuberculosis in their feces. An animal that was fecal culture positive for M. paratuberculosis by any of the three laboratories was considered a confirmed case of infection. The specificity of three ELISAs (two on serum and one on milk) was ≥99.8%. The specificity of the remaining two ELISAs, both done on serum, was 94.9 and 84.7%. Four of the five ELISAs evaluated produced similar sensitivity in detecting fecal culture-positive cattle (27.8 to 28.9%). Serum ELISA “D” had the lowest specificity (84.7%) and the highest sensitivity (44.5%), but if the cutoff value defining a positive test was changed from 125 to 250% (of the positive control) the sensitivity and specificity, 31.8 and 97.5%, respectively, were comparable to those of the other four assays. If the case definition for M. paratuberculosis infection was based on the culture results of a single laboratory instead of the combined results of three laboratories, ELISA sensitivity estimates were 45.7 to 50.0%. With the exception of ELISA D, assay agreement was high (kappa 0.66 to 0.85) for categorical assay interpretations (positive or negative), but linear regression of quantitative results showed low correlation coefficients (r 2 = 0.40 to 0.68) due to the fact that ELISA results for some cows were high in one assay but low in another assay. Likelihood ratio analysis showed a direct relationship between the magnitude of ELISA result and the odds of a cow shedding M. paratuberculosis in its feces. If used judiciously and interpreted quantitatively, these ELISAs are useful tools in support of paratuberculosis control programs in dairy herds.
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7

Fawcett, PaulT, KathleenM Gibney, and RobertA Doughty. "GLOVE POWDER AND HIV ELISA TESTS." Lancet 333, no. 8646 (May 1989): 1082–83. http://dx.doi.org/10.1016/s0140-6736(89)92484-7.

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8

DAVISON, H. C., M. V. THRUSFIELD, A. HUSEIN, S. MUHARSINI, S. PARTOUTOMO, P. RAE, and A. G. LUCKINS. "The occurrence of Trypanosoma evansi in buffaloes in Indonesia, estimated using various diagnostic tests." Epidemiology and Infection 124, no. 1 (February 2000): 163–72. http://dx.doi.org/10.1017/s0950268899003271.

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The prevalence and incidence of Trypanosoma evansi infections in village buffaloes in Central Java were estimated using parasitological tests, two antigen-detection ELISAs (2G6 Ag-ELISA and Tr7 Ag-ELISA), an antibody-detection ELISA (IgG ELISA) and a card agglutination test (CATT). Of 2387 village buffaloes tested in five districts, 4% (95% confidence interval [CI]: 3%, 5%) were positive with the microhaematocrit test (MHCT), 58% (95% CI: 56%, 60%) were positive with the 2G6 Ag-ELISA and 70% (95% CI: 68%, 72%) were positive with the Tr7 Ag-ELISA. An increasing prevalence with age was found and the proportion of positive buffaloes was highest in the over 84 months-old age-group (68%) with the 2G6 Ag-ELISA and in the 37–60 months-old age-group (78%) with the Tr7 Ag-ELISA. Parasitaemic buffaloes were found in more than half of the villages visited. Corrected village-specific prevalence values obtained with the two Ag-ELISAs ranged from 0% to over 100%, and prevalence differed significantly (P[les ]0·0001) between villages in four of the five districts. Overall, 10% of buffaloes tested in markets were found to be parasitaemic and 39, 56 and 47% were found positive with the 2G6 Ag-ELISA, IgG ELISA and CATT, respectively. Incidence rates varied according to the test used and ranged from 0·22 (95% CI: 0·09, 0·44) to 0·44 (95% CI: 0·24, 0·76), per animal-year at risk, in two villages. The results highlight the importance of using validated diagnostic tests to obtain accurate estimates of prevalence and incidence. These parameters are needed, for example in mathematical models, for the development and evaluation of different control strategies for T. evansi infections in buffaloes.
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9

Veling, J., F. G. van Zijderveld, A. M. van Zijderveld-van Bemmel, Y. H. Schukken, and H. W. Barkema. "Evaluation of Two Enzyme-Linked Immunosorbent Assays for Detecting Salmonella enterica subsp.enterica Serovar Dublin Antibodies in Bulk Milk." Clinical Diagnostic Laboratory Immunology 8, no. 6 (November 1, 2001): 1049–55. http://dx.doi.org/10.1128/cdli.8.6.1049-1055.2001.

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ABSTRACT Two enzyme-linked immunosorbent assays (ELISAs) for the detectingSalmonella enterica subsp. entericaserovar Dublin antibodies in bulk milk were developed and evaluated for potential use in control programs. The ELISAs were based on either lipopolysacharide (LPS ELISA) or flagellar antigen (GP ELISA). Sensitivity was determined with 79 case herds with a wide range of clinical signs. Specificity was determined with 125 Dutch and 200 Swedish control herds. The relation between antibodies in bulk milk, antibodies in serum, and the level of milk production of individual cows was studied with 61 case herds. The optimal optical density (OD) values of the LPS ELISA and the GP ELISA were determined to be 0.2 and 0.5, respectively. The sensitivities of the LPS ELISA and the GP ELISA were 54 and 63%, respectively, with a specificity of 98% for both ELISAs with samples from the Dutch control herds. The specificities for samples from the Swedish herds were 100% for the LPS ELISA and 95% for the GP ELISA. The sensitivity of the combination of tests was 65% when samples were run in parallel, and the specificity was 100% when samples were run in series, irrespective of whether the samples came from Dutch or Swedish control herds. The variance (R 2) in the OD value for bulk milk samples could be explained by the percentage of seropositive lactating cows in a herd with the LPS ELISA for 51% of the samples and with the GP ELISA for 72%. The variance in the OD value was best explained by the combination of the percentage of seropositive lactating cows in the herd and the mean log10 serum antibody titer for that herd (R 2 = 62% for the LPS ELISA andR 2 = 75% for the GP ELISA). Case herds more often tested negative by the ELISA with bulk milk when the percentage of seropositive lactating cows was less than 5%. It is concluded that both ELISAs with bulk milk can be used in control programs to distinguish between infected and noninfected herds. Specificity can be increased by using the two tests in combination. Sensitivity was relatively low for both single tests and both tests combined.
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10

Morenkov, O. S., Nadja Fodor, and I. Fodor. "Indirect Elisas Based on Recombinant and Affinity-Purified Glycoprotein E of Aujeszky's Disease Virus to Differentiate Between Vaccinated and Infected Animals." Acta Veterinaria Hungarica 47, no. 1 (January 1, 1999): 137–50. http://dx.doi.org/10.1556/avet.47.1999.1.15.

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Two indirect ELISAs for the detection of antibodies against glycoprotein E (gE) of Aujeszky's disease virus (ADV) in sera have been developed. The rec-gE-ELISA is based on theE. coli-expressed recombinant protein containing the N-terminal sequences of gE (aa 1-125) fused with the glutathione S-transferase fromSchistosoma japonicum. The affi-gE-ELISA is based on native gE, which was purified from virions by affinity chromatography. The tests were optimised and compared with each other, as well as with the recently developed blocking gE-ELISA (Morenkov et al., 1997b), with respect to specificity and sensitivity. The rec-gE-ELISA was less sensitive in detecting ADV-infected animals than the affi-gE-ELISA (sensitivity 80% and 97%, respectively), which is probably due to the lack of conformation-dependent immunodominant epitopes on the recombinant protein expressed inE. coli. The specificity of the rec-gE-ELISA and affi-gE-ELISA was rather moderate (90% and 94%, respectively) because it was necessary to set such cut-off values in the tests that provided a maximum level of sensitivity, which obviously increased the incidence of false positive reactions. Though the indirect ELISAs detect antibodies against many epitopes of gE, the blocking gE-ELISA, which detects antibodies against only one immunodominant epitope of gE, showed a better test performance (specificity 99% and sensitivity 98%). This is most probably due to rather high dilutions of the sera used in the indirect gE-ELISAs (1:30) as compared to the serum dilution in the blocking gE-ELISA (1:2). We conclude that the indirect gE-ELISAs are sufficiently specific and sensitive to distinguish ADV-infected swine from those vaccinated with gE-negative vaccine and can be useful, in particularly affi-gE-ELISA, as additional tests for the detection of antibodies to gE.
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11

McDougall, Scott. "Effect of calf age on bovine viral diarrhea virus tests." Journal of Veterinary Diagnostic Investigation 33, no. 3 (March 5, 2021): 528–37. http://dx.doi.org/10.1177/1040638721998821.

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Bovine viral diarrhea virus (BVDV) causes significant economic loss in cattle. Detection of persistently infected (PI) animals is an important control measure, but persistence of maternal antibodies may result in false-negative test results. We assessed the sensitivity and specificity of 2 antigen ELISAs (Idexx BVDV Ag/Serum Plus and BVDV PI X2) and a reverse-transcription real-time PCR (RT-rtPCR; Idexx RealPCR BVDV) assay for detecting PI calves. Ear notch samples were collected from 1,030 calves ~3, 10, 24, and 38 d old (days 3, 10, 24, and 38). All day 38 samples were tested using 2 antigen ELISAs and RT-rtPCR, and any calf that tested positive by any of these tests was blood sampled at ~100 d old (day 100) for antigen and antibody testing by ELISA; samples collected on days 3, 10, and 24 were tested using the antigen ELISAs and PCR. Calves were defined as PI if they were test-positive on day 38 by either ELISA or PCR and were antigen-positive on day 100. Twenty-six calves were PCR BVDV test–positive and one was BVDV PI X2 ELISA–positive at day 38. Five calves were defined as PI, and all tested positive by ELISAs and RT-PCR assay on days 3, 10, and 24. The sensitivity and specificity were 100% for both antigen ELISAs and 96.7% and 100%, respectively, by RT-rtPCR. Test results were not affected by calf age, suggesting that testing for PI calves can be undertaken at any age.
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12

Ruiz Moreno, Yorleydy, Silvia Tavares Donato, Fátima Nogueira, and Marcelo Sousa Silva. "Comparative Analysis of the Serological Reactivity of Individuals with Clinical History of Malaria using Two Different ELISA Tests." Diagnostics 9, no. 4 (October 30, 2019): 168. http://dx.doi.org/10.3390/diagnostics9040168.

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Early diagnosis of malaria reduces disease, prevents deaths, and contributes to decreased malaria transmission. The use of specific and sensitive antigens in the execution of serological diagnostics may have an impact on the transmission of the disease. However, many individuals cannot be easily diagnosed by serological tests due to low levels of antibodies in the serum. Using two different Enzyme-Linked Immunosorbent Assay (ELISA) tests (a commercial and an in-house ELISA), a total of 365 serum samples from individuals with a clinical history of malaria were analyzed. From the serum samples analyzed, 192 (53%) samples from the commercial ELISA and 219 (60%) samples from the in-house ELISA presented positive serological reactivity to malaria. The concordance of the samples tested (n = 365) between both ELISAs was of 67% (n = 242), and with the negative control was 100% (n = 17). We demonstrated that the in-house ELISA showed high antigenic reactivity to Plasmodium falciparum antigens when compared with the commercial ELISA. The degree of concordance of both ELISAs suggested the possibility of existence of other P. falciparum antigens present in the crude extract of P. falciparum that are important in the serological response during malaria infection.
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13

Pearson, Gary R. "ELISA tests and monoclonal antibodies for EBV." Journal of Virological Methods 21, no. 1-4 (September 1988): 97–104. http://dx.doi.org/10.1016/0166-0934(88)90056-0.

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14

DAVISON, H. C., M. V. THRUSFIELD, S. MUHARSINI, A. HUSEIN, S. PARTOUTOMO, P. F. RAE, R. MASAKE, and A. G. LUCKINS. "Evaluation of antigen detection and antibody detection tests for Trypanosoma evansi infections of buffaloes in Indonesia." Epidemiology and Infection 123, no. 1 (August 1999): 149–55. http://dx.doi.org/10.1017/s0950268899002575.

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Two Ag-ELISAs, an IgG-specific antibody detection ELISA (IgG ELISA) and a card agglutination test (CATT) for the detection of Trypanasoma evansi infections in buffaloes in Indonesia, were compared. Diagnostic sensitivity estimates were obtained by testing sera from 139 Indonesian buffaloes which had been found to be infected by parasitological tests. Diagnostic specificity was estimated by testing sera from 263 buffaloes living in Australia. Response-operating characteristic curves were constructed, and optimal ELISA cut-off values, which minimized the number of false–negative and false–positive results, were chosen. The IgG ELISA had the highest sensitivity (89%) and the CATT had the highest specificity (100%). There was a significant difference between the sensitivities (71 and 81%), but not between the specificities (75 and 78%), of the two Ag-ELISAs. The four tests were further compared by calculation of post-test probabilities of infection for positive and negative test results using a range of prevalence values, and likelihood ratios. The results suggested that the CATT was the best test to ‘rule-in’ infection (i.e. the highest probability of infection in test-positive animals) and the IgG ELISA was the best test to ‘rule-out’ infection (i.e. the lowest probability of infection in test-negative animals).
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15

Yerramadha, Muralidhar Reddy, Aakash Desai, and Subramanian Seshan. "Are We Doing Too Many HIT Tests?" Blood 118, no. 21 (November 18, 2011): 1240. http://dx.doi.org/10.1182/blood.v118.21.1240.1240.

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Abstract Abstract 1240 Background: Heparin-induced thrombocytopenia (type II-HIT) is a serious immune mediated clinicopathologic syndrome that may lead to significant arterial or venous thromboembolism and moderate to severe thrombocytopenia. Type II-HIT is estimated to occur with a frequency of 0.2 to 5.0 % after exposure to heparin. Objective: To determine the incidence of type II-HIT and the necessity of its testing within a single, 450-bed, urban, teaching, community hospital. Methods: A retrospective review of the hospital database of inpatient and laboratory medical records was performed for a one-year period from July 2009 to July 2010. Medical records were reviewed to determine how many patients were tested for HIT (i.e., solid phase immunoassay or H-PF4-ELISA) - with the test results and how many confirmatory Serotonin Release Assays (SRA) were performed and the test results. Data was categorized into subgroups depending on the type of care, diagnosis, type of heparin and the dosage of heparin. The percentage of SRA positivity for different strengths of H-PF4-ELISA positivity was also investigated with optical density (OD) at 405 nm (weakly positive with O.D 0.4–0.99, intermediately positive with O.D. 1–1.99 and strongly positive if O.D. equal or more than 2). Pretest probability was also calculated by using 4T's score for all patients with positive ELISA. Results: A total of 19,474 patient admissions occurred over the one year period. An estimated 213 patients had H-PF4-ELISA tests done. Overall H-PF4-ELISA testing incidence was 1% (213 out of 19,474), overall incidence of H-PF4-ELISA positivity out of all admissions during that year was 0.2% (42 out if 19,474). In this study higher frequency of HIT (H-PF4 ELISA) testing was observed in patients who were treated in ICU and cardiac care unit as well as patients treated for sepsis and venous thromboembolism (VTE). The most common type of heparin associated with higher rate of HIT testing was unfractionated heparin-UFH (prophylactic dose more than therapeutic dose) as compared to low molecular weight heparin-LMWH. The incidence of ELISA test positivity was greatest among patients in the ICU and cardiac care unit and patients with sepsis and VTE. Higher incidence of ELISA positivity was associated with UFH. Out of all performed HIT tests ELISA positivity was 19.71% (42 out of 213) and 171 ELISA tests were negative. 36 of the positive ELISA tests were weakly positive, indicating very low probability of HIT. Out of 42 positive ELISA tests 50% (total 21 of 42) had SRA and none of the SRA returned positive. For all 42 patients with positive ELISA tests, the pretest probability was calculated using the 4T score. These show that of the 42 positive ELISA tests, 52.38% (22 of 42) had a low probability, 28.57 (12 of 42) had an intermediate probability, and only 11.9% (5 of 42) had a high probability. Conclusions: From this study, we conclude that in our institute we are doing too many HIT studies. To avoid unnecessary testing and improve cost effectiveness, this study emphasizes the importance of considering clinical situation and pretest probability very carefully, prior to testing. Disclosures: No relevant conflicts of interest to declare.
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16

Marín, C. M., E. Moreno, I. Moriyón, R. Díaz, and J. M. Blasco. "Performance of Competitive and Indirect Enzyme-Linked Immunosorbent Assays, Gel Immunoprecipitation with Native Hapten Polysaccharide, and Standard Serological Tests in Diagnosis of Sheep Brucellosis." Clinical Diagnostic Laboratory Immunology 6, no. 2 (March 1, 1999): 269–72. http://dx.doi.org/10.1128/cdli.6.2.269-272.1999.

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ABSTRACT Competitive and standard enzyme-linked immunosorbent assays (ELISAs), rose bengal (RB), complement fixation, and agar gel immunoprecipitation with native hapten (AGID-NH) were compared by using sera from Brucella-free, Brucella melitensis-infected, and B. melitensisRev1-vaccinated sheep. The most sensitive tests were indirect ELISA and RB, and the most specific tests were AGID-NH and competitive ELISA. We show that RB followed by AGID-NH is a simple and effective system for diagnosing sheep brucellosis.
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17

Windt, M. L., P. J. D. Bouic, C. J. Lombard, R. Menkveld, and T. F. Kruger. "Antisperm Antibody Tests: Traditional Methods Compared to Elisa." Archives of Andrology 23, no. 2 (January 1989): 139–45. http://dx.doi.org/10.3109/01485018908986836.

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18

Palla, Piero, Adolfo Moretti, Fausto Pecori, and Renato Vanacore. "Third-Generation HIV-1/HIV-2 ELISA Tests." Vox Sanguinis 67, no. 2 (1994): 240. http://dx.doi.org/10.1159/000462600.

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19

Hanna, J., S. D. Neill, and J. J. O'Brien. "ELISA tests for antibodies in experimental bovine tuberculosis." Veterinary Microbiology 31, no. 2-3 (June 1992): 243–49. http://dx.doi.org/10.1016/0378-1135(92)90082-5.

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Palla, Piero, Adolfo Moretti, Fausto Pecori, and Renato Vanacore. "Third-Generation HIV-1/HIV-2 ELISA Tests." Vox Sanguinis 67, no. 2 (August 1994): 240. http://dx.doi.org/10.1111/j.1423-0410.1994.tb01670.x.

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21

Póvoa, Marinete M., Ricardo L. D. Machado, Maria N. O. Segura, Giselle M. R. Vianna, Adenildo S. Vasconcelos, and Jan E. Conn. "Infectivity of malaria vector mosquitoes: correlation of positivity between ELISA and PCR-ELISA tests." Transactions of the Royal Society of Tropical Medicine and Hygiene 94, no. 1 (January 2000): 106–7. http://dx.doi.org/10.1016/s0035-9203(00)90457-7.

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22

Kalis, C. H. J., H. W. Barkema, J. W. Hesselink, C. van Maanen, and M. T. Collins. "Evaluation of Two Absorbed Enzyme-Linked Immunosorbent Assays and a Complement Fixation Test as Replacements for Fecal Culture in the Detection of Cows Shedding Mycobacterium Avium Subspecies Paratuberculosis." Journal of Veterinary Diagnostic Investigation 14, no. 3 (May 2002): 219–24. http://dx.doi.org/10.1177/104063870201400305.

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Control of paratuberculosis in dairy herds is based on preventing the transmission of Mycobacterium avium subsp. paratuberculosis ( Mptb) from cows to calves by management measures, supported by removal of cows excreting these bacteria by the fecal route ( Mptb shedders). Fecal culture is the most accurate test for identifying Mptb shedders, but this technique is expensive and takes up to 16 weeks for results to be available. Serologic tests are inexpensive, rapid, and easy to perform. Of serologic tests, the complement fixation test (CFT) and absorbed enzyme-linked immunosorbent assay (ELISA) are the serologic tests used most frequently; the CFT is considered less accurate than the ELISA with respect to sensitivity and specificity. The commonly accepted absorbed ELISA is from the Australian Central Serum Laboratory. However, a European supplier has marketed a second ELISA that is supposed to be more sensitive in detecting Mptb shedders. These 2 absorbed ELISAs, designated ELISA-A and ELISA-B, and an in-house CFT were compared with data from 2 serum panels. The Mptb shedding panel consisted of sera from 198 culture-positive cows from 53 infected herds. The method used for culture of fecal samples was a modified Jørgensen method on individual samples. The Mptb shedder detection rate by the 3 serologic tests ranged from 29.8% to 39.4%. Detection rate for ELISA-A was lower than that for ELISA-B and CFT. For all 3 tests, detection rate was dependent on the level of Mptb shedding and the age of the animals. Detection rates increased as cattle age increased to 4 years. The specificity panel was initially composed of sera from 811 cows randomly selected from 41 herds without clinical paratuberculosis that were negative for Mptb based on whole-herd fecal culture. The modified Jørgensen method for culture was used on pooled fecal samples. Serologic test specificity ranged from 93.4% to 99.8%. The specificity of ELISA-A was higher than that of ELISA-B and CFT. Specificity of ELISA-B between herds was 75–100%. Specificity of CFT between herds was 62–100%. The low specificity of ELISA-B and CFT could not be explained by a higher sensitivity for Mptb-infected cows before onset of shedding, because in the 19 herds with 8 more subsequent negative whole-herd fecal cultures in the 4 years after sampling, specificity was not improved. The insufficient specificity of ELISA-B was not corrected sufficiently by heightening the cutoff value because Mptb shedder detection rate was lowered to 28.9%, equal to that of ELISA-A, and specificity only rose to 97%, much lower than that of ELISA-A. Taking into account the different test characteristics, serologic tests are a cost-effective alternative to fecal culture in high-prevalence herds. For certification programs, only ELISA-A is recommended because in a large number of nonsuspect herds specificity remained almost 100%.
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Yadav, Sulekha, Rekha Barapatre, Ravendra Sharma, Arvind Neral, and Pradip Barde. "Proposed Algorithm for Hepatitis E Virus Diagnosis in the Early Phase of Illness." Intervirology 63, no. 1-6 (2020): 66–70. http://dx.doi.org/10.1159/000510725.

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Hepatitis E virus (HEV), a major etiologic agent of enterically transmitted hepatitis worldwide, is known to cause outbreaks. Diagnosis of the causative agent is important for patient management, understanding epidemiology and outbreak mitigation. We attempted to develop an algorithm for molecular diagnosis and compared the diagnostic accuracy of 2 of HEV IgM ELISA tests during an outbreak. Eighty-four blood samples collected during an outbreak in central India were referred to a nodal laboratory for confirmation of diagnosis. The samples were tested by serological and molecular testes. The results were analyzed by statistical tests. Both the IgM ELISAs were equally competent to diagnose HEV infection when samples were collected after 7.95 ± 3.2 days of onset of illness, whereas nRT-PCR proved a better test when samples were collected between 0 and 6.17 ± 1.97 days of illness. During HEV outbreaks, it is not possible to test all suspected cases by both serological and molecular tests; we suggest testing all ELISA-negative and samples collected in early phase (<7 days) of illness by molecular tests to rule out false-negative results. More studies with large sample size will aid in designing national guidelines for molecular diagnosis of HEV.
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Williams, Roy, Dion Henri Du Plessis, and Wouter Van Wyngaardt. "Group-Reactive ELISAs for Detecting Antibodies to African Horsesickness and Equine Encephalosis Viruses in Horse, Donkey, and Zebra Sera." Journal of Veterinary Diagnostic Investigation 5, no. 1 (January 1993): 3–7. http://dx.doi.org/10.1177/104063879300500102.

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Group-reactive enzyme-linked immunosorbent assays (ELISAs) were developed to selectively detect antibodies to African horsesickness virus (AHSV) and equine encephalosis virus (EEV), 2 orbiviruses that infect equids. In indirect ELISA, guinea pig antisera to all known AHSV or EEV serotypes recognized immobilized AHSV serotype 3 or EEV Cascara, respectively. Antisera from naturally infected animals did not cross-react with their respective heterologous viruses. The ELISA was used in parallel with the complement fixation (CF) and agar gel immunodiffusion tests to detect antibodies in sera from animals in the field. The ELISA distinguished among those that contained antibodies to AHSV, EEV, or both viruses and was useful with sera that did not yield results in CF tests because of anticomplementary activity. Zebra and donkeys, both potential subclinical carrier animals in Africa, contained AHSV or EEV antibodies. Some sera reacted with 1 of the 2 orbiviruses, whereas others reacted with both. The ELISA can be used in projected epidemiological studies in which many serum samples must be assayed.
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Hutagalung, I., Uleng Bahrun, Mansyur Arif, Rifai Amirudin, and HAM Akil. "ANALISIS TES IMUNOKROMATOGRAFI DAN ENZYME-LINKED IMMUNOSORBENT ASSAY UNTUK MENDETEKSI Helicobacter pylori DI PASIEN DISPEPSIA." INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY 15, no. 3 (March 16, 2018): 102. http://dx.doi.org/10.24293/ijcpml.v15i3.959.

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Many methods are available to diagnose Helicobacter pylori in patients with dyspepsia, including Enzyme-Linked ImmunosorbantAssay (ELISA) and recently used is immnochromatography test. Both of the test are non invasive method, but immunochromatographytest can be used in laboratory without semi automatic analyzer. The aim of this study was to compare the immunochromatographyand ELISA tests in detecting the possibility of Helicobacter pylori infection. A cross sectional study was done among 49 sampleswith dyspepsia at Wahidin Sudirohusodo Hospital of Makassar and Prodia Laboratory from March to August 2008. Samples wereanalyzed with SPSS 14 for Windows Program using Chi Square and Spearman correlation tests. Among 49 samples we found ELISAand immunochromatography tests were positive in 5 samples, ELISA and immunochromatography tests were negative in 33 samples,ELISA tests were borderline and immunochromatography tests were positive in 5 samples, and ELISA tests were borderline andimmunochromatography tests were negative in 6 samples. There was a good correlation between ELISA and immunochromatographytest with R = 1.000 and p = 0.000. Both results of the immunochromatography and ELISA tests showed high conformity. Both methodcan be applied to diagnose Helicobacter pylori in patients with dyspepsia. Immunochromatography test can be an alternative methodin laboratories who do not apply semi automatic analyzer. The advantages of immunochromatography test can be used for diagnoseearly infection of Helicobacter pylori.
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Girl, Philipp, Sonja Mantel, Heiner von Buttlar, Roman Wölfel, and Katharina Müller. "Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies." Viruses 14, no. 3 (March 11, 2022): 577. http://dx.doi.org/10.3390/v14030577.

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In December 2020, WHO presented the first international standard (WHO IS) for anti-SARS-CoV-2 immunoglobulin. This standard is intended to serve as a reference reagent against which serological tests can be calibrated, thus creating better comparability of results between different tests, laboratories, etc. Here, we have examined three different commercial ELISA kits for the quantification of SARS-CoV-2 IgG antibodies, namely the Anti-SARS-CoV-2 QuantiVac ELISA (IgG) (Euroimmun, Lübeck, Germany), the SERION ELISA agile (Institut Virion Serion, Würzburg, Germany), and the COVID-19 quantitative IgG ELISA (DeMediTec Diagnostics, Kiel, Germany). According to the manufacturers, all are calibrated against the WHO IS and can provide results in either international units (IU) (DeMediTec) or arbitrary antibody units (BAU) per milliliter (Euroimmun, Virion Serion), which are numerically identical, according to the WHO. A total of 50 serum samples from vaccinated individuals were tested side by side and according to the manufacturer’s instructions. We compared the test results of all three assays with each other to assess comparability and with a quantitative in-house virus neutralization test (micro-NT). In summary, our data are consistent with other studies published on this topic that tested similar assays from different manufacturers. Overall, the agreement between quantitative ELISAs is variable and cannot be used interchangeably despite calibration against a standard. Therefore, interpretation of results must still be individualized and tailored to each case. More importantly, our results highlight that quantitative ELISAs in their current form cannot replace neutralization tests.
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Shah, Syed Zia-ur-Rehman, and Seshan Subramanian. "Are We Doing Too Many HIT Tests III?" Blood 132, Supplement 1 (November 29, 2018): 2444. http://dx.doi.org/10.1182/blood-2018-99-110035.

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Abstract Background In USA in 2007, it was estimated that approximately one third of hospitalized patients, approximately 12 million patients per year receive heparin. Heparin induced thrombocytopenia (HIT) is one of the serious complications of Heparin resulting from immune mediated antibody. 4Ts score is the imperative tool to help differentiate HIT from other causes of thrombocytopenia. The 4Ts score decreases not only risk of bleeding by avoiding anticoagulant but also cost of health care by testing only patients with intermediate to high pretest probability. Our study suggests 4Ts scores calculators are to be introduced as a part of order set for HIT tests. Objective This retrospective study is Part III of our prior studies " Are We Doing Too Many HIT tests", to decrease false positive HIT patients by improving use and awareness about high negative predictive value of 4T score among physicians. This study was carried out to determine outcomes of our previous study of this series in order to assess the reduction of unnecessary ELISA test orders to diagnose HIT in a single urban community hospital in Chicago. Method A retrospective chart review of medical records of the patients (n=181) who underwent H-PF4-ELISA for HIT screening from January 1st, 2016 to December 31st 2017 was conducted. Data was collected from patient's charts which included the requesting department (i.e. ICU, ED, Medical and surgical floors). Also, date of admission, date of onset of platelet drop, degree of thrombocytopenia, incidence of DVT, PE, arterial thrombosis and bleeding and alternative reasons of platelet count drop other than HIT were collected. For each patient a for calculation of Pretest probability by the 4T score was conducted. We stratified these patients based on 4Ts score (0-3) for low probability, (4-5) intermediate probability and (6-8) high probability risk for HIT. We reviewed all charts for which both ELISA and SRA were ordered. Pharmacy department and Hematology labs were contacted to calculate costs of ELISA, SRA and anticoagulation. Results Our results showed that 114 (62.98%) of 181 ELISA tests ordered had low pretest probability for HIT. None of these records were found to be true positive by SRA. However, 24(20%) of low probability category were found positive by ELISA and received anticoagulation and thus were exposed to higher risk of bleeding and additional health care costs. There were 57 (31.49%) out of 181 records had intermediate probability. 16 patients with intermediate probability were ELISA test positive. However, 3 (5.26%) of intermediate probability patients were found to be true positive by SRA. While only 6 (3.31%) out of 181 patients records had high probability for HIT and 3 patients (50%) of high probability were found to be true positive by SRA. However, 11 patients from low probability category and 5 patients from intermediate probability category did not have SRA results in their medical record. Discussion In our previous study, 74.3% of patients tested for HIT during Jan.2013 to Dec. 2014were found to have low probability compared to 62.98% of our current study. Interestingly, patients with intermediate probability have increased to 31.49% from 18% from our previous study. This is a desired decreased. Cost for ELISA test for HIT ranges $200 to $300 per test and cost of SRA is roughly $50 to $60. Cost of one day of Argatroban treatment is roughly $670 which brings the total cost per patient roughly $1000 per day for all those patients who are tested positive by ELISA. 34,200 USD were spent on ELISA test for 114 patients with low probability 4T score who were found true negative. Furthermore, 20 patients with false positive ELISA from low probability 4T category were exposed to 40,200 USD worth of Argatroban during three days while SRA results were awaited. As per our study, educational interventions in our hospital have made remarkable improvement in decreasing the number of ELISA test in patients with low pretest probability from 74.3% to 62.98% Lastly, more than 74,000 USD per 114 patients (with low probability score) could be reduced by introducing "4T score calculation Alert" as a part of order set for HIT in EMR software. We conclude that incorporating prescreening for HIT with 4T score calculation as a part of order set for ELISA could decrease not only the risk of bleeding but also avoidable additional health care cost. Disclosures No relevant conflicts of interest to declare.
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Galula, Jedhan Ucat, Gielenny M. Salem, Raul V. Destura, Roland Remenyi, and Day-Yu Chao. "Comparable Accuracies of Nonstructural Protein 1- and Envelope Protein-Based Enzyme-Linked Immunosorbent Assays in Detecting Anti-Dengue Immunoglobulin G Antibodies." Diagnostics 11, no. 5 (April 21, 2021): 741. http://dx.doi.org/10.3390/diagnostics11050741.

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Background: Dengue virus (DENV) infection remains a global public health concern. Enzyme-linked immunosorbent assays (ELISAs), which detect antibodies targeting the envelope (E) protein of DENV, serve as the front-line serological test for presumptive dengue diagnosis. Very few studies have determined the serostatus by detecting antibodies targeting the nonstructural protein 1 (NS1), which can function as diagnostic biomarkers to distinguish natural immunity from vaccine-induced immunity. Methods: We used community-acquired human serum specimens, with the serostatus confirmed by focus reduction microneutralization test (FRμNT), to evaluate the diagnostic performances of two NS1-based ELISA methods, namely, immunoglobulin G antibody-capture ELISA (NS1 GAC–ELISA) and indirect NS1 IgG ELISA, and compared the results with an E-based virus-like particle (VLP) GAC–ELISA. Results: NS1-based methods had comparable accuracies as VLP GAC–ELISA. Although the sensitivity in detecting anti-NS1 IgM was poor, indirect NS1 IgG ELISA showed similar limits of detection (~1–2 ng/mL) as NS1 GAC–ELISA in detecting anti-NS1 IgG. Combining the results from two or more tests as a composite reference standard can determine the DENV serostatus with a specificity reaching 100%. Conclusion: NS1-based ELISAs have comparable accuracies as VLP GAC–ELISA in determining dengue serostatus, which could effectively assist clinicians during assessments of vaccine eligibility.
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Jacot, Damien, Milo Moraz, Alix T. Coste, Christele Aubry, Jilian A. Sacks, Gilbert Greub, and Antony Croxatto. "Evaluation of sixteen ELISA SARS-CoV-2 serological tests." Journal of Clinical Virology 142 (September 2021): 104931. http://dx.doi.org/10.1016/j.jcv.2021.104931.

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Dayal, R., G. Sirohi, M. K. Singh, P. P. Mathur, B. M. Agarwal, V. M. Katoch, B. Joshi, P. Singh, and H. B. Singh. "Diagnostic Value of Elisa Serological Tests in Childhood Tuberculosis." Journal of Tropical Pediatrics 52, no. 6 (May 8, 2006): 433–37. http://dx.doi.org/10.1093/tropej/fml047.

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31

Talarmin, Antoine, Bhety Labeau, Josiane Lelarge, and Jean-Louis Sarthou. "Immunoglobulin A-Specific Capture Enzyme-Linked Immunosorbent Assay for Diagnosis of Dengue Fever." Journal of Clinical Microbiology 36, no. 5 (1998): 1189–92. http://dx.doi.org/10.1128/jcm.36.5.1189-1192.1998.

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Dengue fever (DF) is usually diagnosed by testing for dengue virus immunoglobulin M (IgM) by a capture enzyme-linked immunosorbent assay (ELISA) (MAC-ELISA). However, IgM can last for months, and its presence might reflect a previous infection. We have tested the use of anti-dengue virus IgA capture ELISA (AAC-ELISA) for the diagnosis of DF by comparing the results of MAC-ELISAs and AAC-ELISAs for 178 serum samples taken from patients with confirmed cases of DF. IgM appears more rapidly (mean delay of positivity, 3.8 days after the onset of DF) than IgA (4.6 days) but lasts longer; the peak IgA titer is obtained on day 8. The specificity and the positive predictive value of AAC-ELISA are 100%; its sensitivity and negative predictive value (NPV) are also 100% between days 6 and 25 after the onset of DF, but they decrease drastically when data for tests conducted with specimens from the first days of infection are included, because the IgA titers, like the IgM titers, have not yet risen. AAC-ELISA is a simple method that can be performed together with MAC-ELISA and that can help in interprating DF serology.
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Luciano, R. L., A. L. S. P. Cardoso, G. F. Z. Stoppa, A. M. I. Kanashiro, A. G. M. de Castro, and E. N. C. Tessari. "Comparative Study of Serological Tests forMycoplasma synoviaeDiagnosis in Commercial Poultry Breeders." Veterinary Medicine International 2011 (2011): 1–5. http://dx.doi.org/10.4061/2011/304349.

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Avian mycoplasmosis causes great economic losses to the poultry industry, and one of the major agents involved isMycoplasma synovie(MS). Serum from commercial poultry breeders () was tested for MS by serum plate agglutination (SPA), hemagglutination inhibition (HI), and enzyme-linked immunosorbent assay (ELISA). From 2,781 samples tested, 736 (26.46%) were positive in SPA. From 712 SPA-positive sera, 30 samples (4.21%) were positive in HI, and 150 samples (21.06%) were positive in ELISA. Copositivity between ELISA and HI was 90%, and conegativity was 82.0%. Agreement between HI and ELISA was rejected by McNemar's test (), and Kappa coefficient showed a weak correlation between the two techniques (; ). Weak statistical correlation was observed between all serological tests (SPA, HI, and ELISA), and they should only be used for initial screening for MS.
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Malan, Annette K., Erick Avelar, Sheldon E. Litwin, Harry R. Hill, and Christine M. Litwin. "Serological diagnosis of Trypanosoma cruzi: evaluation of three enzyme immunoassays and an indirect immunofluorescent assay." Journal of Medical Microbiology 55, no. 2 (February 1, 2006): 171–78. http://dx.doi.org/10.1099/jmm.0.46149-0.

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Chagas' disease is an important cause of heart failure in Latin America, but is rare in the United States. The immigration of persons from endemic countries increases the potential of encountering patients with the disease. Concerns have also been raised about the introduction of Trypanosoma cruzi, the parasite that causes the disease, into the blood supply and during organ transplantation. To compare Chagas' antibody tests that are available in the United States, we evaluated three IgG ELISAs, CeLLabs T. cruzi ELISA, Hemagen Chagas' kit and IVD Research Chagas' Serum Microwell ELISA, and MarDx indirect immunofluorescent assays. The CeLLabs and Hemagen IgG ELISAs had 100 % agreement, sensitivity and specificity. The IVD Research IgG ELISA had 94·6 % agreement, 100 % sensitivity and 93 % specificity.
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Sánchez, Antonio, Antonio Contreras, María L. Sánchez-Corral, Carmen Martínez-Nista, Soledad Collado, José L. Sáez, Olga Minguez, and Christian de la Fe. "Comparison of commercial enzyme-linked immunosorbent assays for diagnosis of contagious agalactia caused by Mycoplasma agalactiae." Journal of Veterinary Research 66, no. 1 (March 1, 2022): 95–101. http://dx.doi.org/10.2478/jvetres-2022-0010.

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Abstract Introduction Contagious agalactia (CA) is a disease affecting small ruminants with worldwide distribution and caused by several mycoplasmas, especially M. agalactiae. The main option for systematic diagnosis under monitoring control programmes is the enzyme-linked immunosorbent assay (ELISA) test. Material and Methods This study was designed to appraise the performance of two commercial indirect ELISA tests using M. agalactiae p48 protein and one using total protein, for antibody detection in small ruminants after natural infection with different M. agalactiae strains. We carried out the test evaluation using sera of confirmed M. agalactiae-positive goats with clinical signs. In addition, test agreement was assessed by kappa between the three commercial ELISA tests. Results All three ELISA tests showed high validity scores (Youden’s J: 72.9–84%). The sensitivity values for the P48 protein-based tests were 76.9% and 84.6%, and was 79% for the total protein-based test. The specificity of all tests was 100%. In addition, between the total protein-based ELISA test and the other two ELISA tests based on the P48 protein, the agreement was substantial (kappa: 0.762–0.763) and the agreement between the latter two tests was almost perfect (kappa: 0.93). Conclusion The validity parameters for all tests allowed their application for diagnostic purposes in lactating goats excreting M. agalactiae in milk and presenting clinical signs. The agreements show that any of these ELISA tests could be equally well used for diagnosis in programmes against CA.
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Ortalli, Margherita, Daniele Lorrai, Paolo Gaibani, Giada Rossini, Caterina Vocale, Maria Carla Re, and Stefania Varani. "Serodiagnosis of Visceral Leishmaniasis in Northeastern Italy: Evaluation of Seven Serological Tests." Microorganisms 8, no. 12 (November 24, 2020): 1847. http://dx.doi.org/10.3390/microorganisms8121847.

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This study compares the performance of seven assays, including two ELISA (Leishmania ELISA IgG + IgM, Vircell Microbiologists; Leishmania infantum IgG ELISA, NovaTec), three rK39-based immunochromatographic tests (rK39-ICTs) (Leishmania Dipstick Rapydtest, Apacor; On Site Leishmania IgG/IgM Combo Rapid Test, CTK Biotech; LEISHMANIA Strip quick Test, Cypress Diagnostic), one indirect immunofluorescent antibody test (IFAT) (Leishmania-Spot IF, BioMérieux), and one western blot (WB) (Leishmania WESTERN BLOT IgG, LDBio Diagnostics) for serodiagnosis of visceral leishmaniasis (VL). Serum samples from 27 VL patients living in northeastern Italy were analyzed, as well as the serum samples from 50 individuals in whom VL diagnosis was excluded. The WB and the IFAT had 96% sensitivity, followed by the ELISA (63% and 74%, respectively). The rK39-ICT exhibited the worst performance among the serological tests, with sensitivities ranging from 52% to 70%. By combining selected ELISA/ICT, the sensitivity of VL detection reached 89%. IFAT and WB outperformed ELISA and rK39-ICT by possessing optimal sensitivity, but their high cost and complexity of execution would not allow their employment as screening tests. In conclusion, the combination of easy-to-perform tests, such as ICT and ELISA, could improve sensitivity in the serodiagnosis of Mediterranean VL.
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Wouda, W., J. Brinkhof, C. van Maanen, A. L. W. de Gee, and A. R. Moen. "Serodiagnosis of Neosporosis in Individual Cows and Dairy Herds: A Comparative Study of Three Enzyme-Linked Immunosorbent Assays." Clinical Diagnostic Laboratory Immunology 5, no. 5 (September 1, 1998): 711–16. http://dx.doi.org/10.1128/cdli.5.5.711-716.1998.

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ABSTRACT The performance of three enzyme-linked immunosorbent assays (ELISA) for detection of antibodies to Neospora caninum in bovine sera was evaluated by using various categories of sera. Two commercial ELISA methods, one based on chemically fixed intact tachyzoites and one based on a sonicate lysate of whole tachyzoites, were compared with an in-house ELISA based on a detergent lysate of whole tachyzoites. A brief description of the development of the latter ELISA is also given. There was good agreement among all three tests with regard to postabortion sera. By using acute-phase abortion sera from cows with confirmedN. caninum-induced and non-N. caninum-induced abortions, satisfactory levels of sensitivity and specificity were calculated for all tests. In addition, similar test results were obtained with postpartum samples from dams and calves. However, considerable differences were found between test results of sequential samples and cross-sectional and total-herd samples. Apparently, these discrepancies were due to different sensitivities of the tests for detection of low antibody levels in chronically infected animals. It is suggested that these differences were primarily due to the use of different antigens and different test sample dilutions. It is concluded that all tests are applicable as an additional diagnostic tool in cases of abortion in cattle and for monitoring of congenitally infected calves. For herd screening, the lysate-based ELISAs appear to be more adequate because of their higher sensitivities.
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Sekongo, Yassongui Mamadou, Saydou Kabore, Bamory Dembele, Kouadio Daniel Yao, Liliane Bogui-Siransy, Jean Luc Adjoumani, Agba Abisse, and Seidou Konaté. "Interest of Confirmation Tests in the Diagnosis of Viral Hepatitis C to Blood Donors in Abidjan-Côte d'Ivoire." Journal of Hematology and Oncology Research 3, no. 3 (January 23, 2020): 32–37. http://dx.doi.org/10.14302/issn.2372-6601.jhor-20-3186.

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Introduction The anti-HCV RIBA test verifies the presence of anti-HCV serum antibodies detected by the Elisa test. In Côte d'Ivoire, screening for hepatitis C is done exclusively by enzyme immunoassays. In order to reduce the number of HCV positive blood donor exclusions on ELISA, we conducted this study which aimed to demonstrate the value of the RIBA test in confirming diagnosis of viral hepatitis C to blood donors. Methods Our study, which took place from 02 to 23 February 2008 in the laboratory of Abidjan NBTC, focused on 200 sera of blood donors anti-HCV positive (Elisa test) selected according to the ratio. The DECISCAN HCV PLUS confirmation test of BIORAD was used. Results Among the 200 HCV samples positive by EIA, 49% (98/200) were confirmed positive. RIBA gave an indeterminate result in 40% of cases (80/200); and negative in 11% of cases (22/200) corresponding to false ELISA devices. In RIBA 96 samples had a low ELISA ratio of which 21% (20/96) were RIBA negative, and 79% (76/96) were indeterminate. RIBA positive samples (98/200) had a high ratio in 82% of cases (80/98). The presence of NS3 (C33) and NS4 (C100) was noted in 100% of cases (98/98, C2 in 37% (36/98) of cases and C1 in 18% of cases (18/98). RIBA indeterminate noted the presence of NS3 in 98% of cases (78/80) and NS4 in 30% of cases (24/80). Proteins C1, C2 and NS4 are essential for the diagnosis of confirmation of viral hepatitis C by RIBA. Conclusion These results attest to the lower specificity of enzyme immunoassays (ELISAs); hence the benefit of using RIBA confirmatory tests. A significant number of donors are excluded from blood donation in Côte d'Ivoire on the basis of false positive results obtained by the ELISA technique.
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Nawagitgul, Porntippa, Perry A. Harms, Igor Morozov, Brad J. Thacker, Steven D. Sorden, Chalermpol Lekcharoensuk, and Prem S. Paul. "Modified Indirect Porcine Circovirus (PCV) Type 2-Based and Recombinant Capsid Protein (ORF2)-Based Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to PCV." Clinical and Vaccine Immunology 9, no. 1 (January 2002): 33–40. http://dx.doi.org/10.1128/cdli.9.1.33-40.2002.

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ABSTRACT Postweaning multisystemic wasting syndrome of swine associated with porcine circovirus (PCV) is a recently reported and economically important disease. Simple and reliable diagnostic methods are needed for detecting antibodies to PCV type 2 (PCV2) for monitoring of PCV infection. Here, we report the development of two modified indirect enzyme-linked immunosorbent assays (ELISAs): a PCV2 ELISA based on cell-culture-propagated PCV2 and an ORF2 ELISA based on recombinant major capsid protein. PCV2 and ORF2 ELISA detected antibodies to PCV2 and the capsid protein, respectively, in sera from pigs experimentally infected with PCV2 as early as 14 and 21 days postinoculation (dpi). The kinetics of the antibody response to PCV2 and the major capsid protein were similar. Repeatability tests revealed that the coefficients of variation of positive sera within and between runs for both assays were less than 30%. To validate the assays, PCV2 and ORF2 ELISAs were performed with 783 serum samples of young and adult pigs collected from different herds in the Midwestern United States and compared with an indirect immunofluorescent assay (IIF). Six out of 60 samples collected from nursery and growing pigs in 1987 were positive by both ELISA and IIF. Compared with IIF, the diagnostic sensitivity, specificity, and accuracy of PCV2 and ORF2 ELISAs were similar (>90%). The tests showed no cross-reactivity with antibodies to porcine parvovirus and porcine reproductive and respiratory syndrome virus. There was good agreement between the two ELISAs and between the ELISAs and IIF. The availability of the two ELISAs should accelerate our understanding of the host immune response to PCV2 and facilitate the development of prevention and control strategies by elucidating the ecology of PCV2 within swine populations.
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de Assis, Tália Santana Machado, Mariana Lourenço Freire, Janaína de Pina Carvalho, Ana Rabello, and Gláucia Cota. "Cost-effectiveness of anti-SARS-CoV-2 antibody diagnostic tests in Brazil." PLOS ONE 17, no. 2 (February 25, 2022): e0264159. http://dx.doi.org/10.1371/journal.pone.0264159.

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Background Although serologic tests for COVID-19 diagnosis are rarely indicated nowadays, they remain commercially available and widely used in Brazil. The objective of this study was to evaluate the cost-effectiveness of anti-SARS-CoV-2antibody diagnostic tests for COVID-19 in Brazil. Methods Eleven commercially available diagnostic tests, comprising five lateral-flow immunochromatographic assays (LFAs) and six immunoenzymatic assays (ELISA) were analyzed from the perspective of the Brazilian Unified Health System. Results The direct costs of LFAs ranged from US$ 11.42 to US$ 17.41and of ELISAs, from US$ 6.59 to US$ 10.31. Considering an estimated disease prevalence between 5% and 10%, the anti-SARS-CoV-2 ELISA (IgG) was the most cost-effective test, followed by the rapid One Step COVID-19 Test, at an incremental cost-effectiveness ratio of US$ 2.52 and US$ 1.26 per properly diagnosed case, respectively. Considering only the LFAs, at the same prevalence estimates, two tests, the COVID-19 IgG/IgM and the One Step COVID-19 Test, showed high effectiveness at similar costs. For situations where the estimated probability of disease is 50%, the LFAs are more costly and less effective alternatives. Conclusions Nowadays there are few indications for the use of serologic tests in the diagnosis of COVID-19 and numerous commercially available tests, with marked differences are observed among them. In general, LFA tests are more cost-effective for estimated low-COVID-19-prevalences, while ELISAs are more cost-effective for high-pretest-probability scenarios.
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Araj, George F., Mireille M. Kattar, Layla G. Fattouh, Kayane O. Bajakian, and Sara A. Kobeissi. "Evaluation of the PANBIO Brucella Immunoglobulin G (IgG) and IgM Enzyme-Linked Immunosorbent Assays for Diagnosis of Human Brucellosis." Clinical Diagnostic Laboratory Immunology 12, no. 11 (November 2005): 1334–35. http://dx.doi.org/10.1128/cdli.12.11.1334-1335.2005.

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ABSTRACT PANBIO Brucella immunoglobulin G (IgG) and IgM enzyme-linked immunosorbent assays (ELISAs) were assessed against Brucella standard agglutination tube and Coombs tests. The sensitivities of ELISA IgG and IgM were 91% and 100%, respectively, while the specificity was 100% for both. These ELISAs are simple, rapid, and reliable for the diagnosis of human brucellosis.
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Saegerman, Claude, Fabien Grégoire, and Laurent Delooz. "Diagnosis of Coxiella burnetii Cattle Abortion: A One-Year Observational Study." Pathogens 11, no. 4 (April 1, 2022): 429. http://dx.doi.org/10.3390/pathogens11040429.

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Q fever is a zoonosis occurring worldwide in livestock. Often neglected in differential diagnoses, Q fever can persist in herds causing financial losses. In ruminants, well-known manifestations of Q fever are metritis, infertility, abortion, stillbirth and delivery of a weak or premature calf. In cattle, Q fever is frequently asymptomatic and/or under-reported. Few studies are available on the diagnosis of Coxiella burnetii as a cause of abortion in cattle using polymerase chain reaction (PCR) for pathogen detection while enzyme-linked immunosorbent assay (ELISA) is used to assess exposure. Moreover, existing studies include a relatively small number of abortions. The aim of this study is to assess, in the southern part of Belgium, during a year, the performance of diagnosis of C. burnetii as a cause of abortion and the putative benefit of enhanced serology using anamnesis (animal patient data, and present, past and environmental history). A one-year random selection of 1212 abortions was analysed both with the PCR method (tissues from fetuses) and two commercialised ELISAs (sera from the mothers). Relative sensitivity and specificity of the ELISA tests were assessed using PCR as the reference test. The prevalence of C. burnetii PCR positive was 8.5% (95% CI: 6.99–10.21). The diagnostic value of the ELISA tests was assessed using the area under the receiver operating characteristic curve (AUC-ROC). The sensitivity, specificity and AUC-ROC were similar for both ELISA tests. The diagnostic capacity of the ELISA was confirmed and slightly enhanced if anamnestic information was integrated with a unique scoring index system. A high negative predictive value was demonstrated and a significant reverse association between Ct values and a percentage of the ratio of the optical density between the sample and the positive control (ELISA A or ELISA B) enabling the use of ELISA as an exclusion diagnostic. This study is original by integrating the serological result and the anamnesis in a single index. It opens a new window in enhanced veterinary clinical decision-making.
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Galea, Vassiliki, Francoise Robert, Patrick Van Dreden, Barry J. Woodhams, Grigoris T. Gerotziafas, Mohamed Hatmi, and Ismail Elalamy. "A Novel Test for the Rapid Rule Out of Heparin-Induced Thrombocytopenia Diagnosis in Intensive Care unit patients." Blood 120, no. 21 (November 16, 2012): 1119. http://dx.doi.org/10.1182/blood.v120.21.1119.1119.

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Abstract Abstract 1119 Introduction Diagnosis of heparin-induced thrombocytopenia (HIT) in intensive care unit (ICU) patients represents a major challenge mainly because both the use of unfractionated heparin and the presence of thrombocytopenia are quite common. Despite the existence of several laboratory tests, accurate and prompt HIT diagnostics remains difficult. The ideal combination of an immunological and a functional test is restrictedto specialized laboratories, due to the complexity of the latter. We are in need of an easy-to-perform, widely accessible, rapid and reliably assay. Aim of the study To prospectively evaluate the performance of the latelar-flow immunoassay STic HIT Expert® (Diagnostica Stago, France) for the detection in ICU patients suspected for HIT. Patients-methods Seventy two patients (40 males/32 females) hospitalized in ICU from January to June 2012 were included. Thirty one patients presented with sepsis, 27 underwent extracorporeal circulation (ECC), 21 were hemodialysed and 3 patients were receiving chemotherapy. Sixty one patients were treated with unfractionated heparin and 11 patients received low molecular weight heparin (LMWH). A 4T's score was performed for all patients. All samples were tested in polyspecific ELISA (Zymutest Hyphen Biomed, Neuville-Sur-Oise, France), STic HIT Expert® (Diagnostica Stago, France) and serotonin release assay. In case of a positive polyspecific ELISA, IgG, IgM et IgA isotypes were also performed. Sensitivity, specificity, positive and negative predictive values (PPV an NPV) of STic HIT Expert® were determined against SRA. Results All three tests (polyspecific ELISA, STic HIT Expert®, SRA) were negative in forty patients and had a low HIT suspicion (4T's score: 0–4). In 10 out of 72 patients polyspecific all immunological tests and SRA were positive and HIT suspicion was intermediate or high (4T's score: 4–7). In 9 patients, ELISA tests and STic HIT Expert® were positive but SRA was negative. These patients had a low HIT suspicion (4T's score: 1–4) and underwent ECC (6 out of 9), were hemodialyzed (3 out of 9) or complicated by sepsis (2 out of 9). On the other hand 13 out of 72 patients had ELISA tests positive but STic HIT Expert® and SRA negative. The prevalence of sepsis was high in these patients (8 out of 13), 3 patients underwent ECC and one patient was hemodialysed. STic HIT Expert®, polyspecific and IgG specific ELISA had an excellent sensitivity and negative predictive value at 100%. Moreover STic HIT Expert® was associated with a smaller number of false positive results than the ELISAs. (Table) Conclusion STic HIT Expert® has an excellent performance with a high negative predictive value (100%) and a satisfactory specificity (85%). Less false positive results are detected with STic HIT Expert® than with polyspecific and IgG specific ELISAs. Moreover the test offers a shorter turnaround than ELISA tests and is an easy-to-use single sample test. These characteristics could help avoid HIT over diagnosis in ICU patients. Disclosures: No relevant conflicts of interest to declare.
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Aubert, D., G. T. Maine, I. Villena, J. C. Hunt, L. Howard, M. Sheu, S. Brojanac, L. E. Chovan, S. F. Nowlan, and J. M. Pinon. "Recombinant Antigens To Detect Toxoplasma gondii-Specific Immunoglobulin G and Immunoglobulin M in Human Sera by Enzyme Immunoassay." Journal of Clinical Microbiology 38, no. 3 (2000): 1144–50. http://dx.doi.org/10.1128/jcm.38.3.1144-1150.2000.

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We have evaluated the diagnostic utility of eleven Toxoplasma gondii recombinant antigens (P22 [SAG2], P24 [GRA1], P25, P28 [GRA2], P29 [GRA7], P30 [SAG1], P35, P41 [GRA4], P54 [ROP2], P66 [ROP1], and P68) in immunoglobulin G (IgG) and IgM recombinant enzyme-linked immunosorbent assays (Rec-ELISAs). Following an initial evaluation, six recombinant antigens (P29, P30, P35, P54, P66, and P68) were tested in the IgG and IgM Rec-ELISAs with four groups of samples which span the toxoplasmosis disease spectrum (negative, chronic infection, acute infection, and recent seroconversion). Our results suggest that the combination of P29, P30, and P35 in an IgG Rec-ELISA and the combination of P29, P35, and P66 in an IgM Rec-ELISA can replace the tachyzoite antigen in IgG and IgM serologic tests, respectively. The relative sensitivity, specificity, and agreement for the IgG P29-P30-P35 Rec-ELISA were 98.4, 95.7, and 97.2%, respectively. The resolved sensitivity, specificity, and agreement for the IgM P29-P35-P66 Rec-ELISA were 93.1, 95.0, and 94.5%, respectively. Relative to the tachyzoite-based immunocapture IgM assay, the IgM P29-P35-P66 Rec-ELISA detects fewer samples that contain IgG antibodies with elevated avidity from individuals with an acute toxoplasmosis.
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Francis, John L., Alane Drexler, Mary Kathryn Duncan, Hina Desai, Mildred Amaya, Theresa Robson, Todd V. Meyer, Edward Reyes, Kristin Rathmann, and Ali Amirkhosravi. "Prospective Evaluation of Laboratory Tests for the Diagnosis of Heparin-Induced Thrombocytopenia." Blood 108, no. 11 (November 16, 2006): 1051. http://dx.doi.org/10.1182/blood.v108.11.1051.1051.

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Abstract The laboratory diagnosis of heparin-induced thrombocytopenia (HIT) relies on the demonstration of antibodies to the heparin-platelet factor 4 (H-PF4) complex. Assays are based on the functional ability of H-PF4 antibodies to activate platelets, or detect the antibody directly by immunological methods. Multiple assays in each category are currently in clinical use and newer, rapid immunological assays are becoming available. The aim of this study was to compare available methods for detecting H-PF4 antibodies in a prospective study of patients with clinically suspected HIT. Functional assessment included serotonin release assay (SRA) and lumi-aggregometry (LA). Immunological assessment included ELISA (GTI), and particle gel immunoassay (PGIA; Diamed and Akers). Circulating platelet microparticles (PMP) were assessed by flow cytometry. Patients were also assessed for the pre-test probability of HIT using the Warkentin 4-T scoring system. 151 patients were enrolled. 54/151 patients (35.8%) had a positive GTI ELISA, while 53/151 (35.1%) and 39/151 (25.8%), respectively, had positive Akers and Diamed PGAI tests. Only 15/149 (10.1%) patients had a positive SRA, while only 5/150 (3.3%) gave a positive result by lumi-aggregometry. There was a strong correlation between the ELISA OD values obtained in serum and plasma using both fresh (r=0.98) and frozen (r=0.99) samples, although slightly more positive results were obtained using serum. Differences were only seen with OD values around the cut-off of 0.4. The majority (77.8%) of H-PF4 antibodies detected by ELISA were neutralized by heparin in the ‘confirmatory’ procedure. Weak antibodies (OD 0.4–0.5) were more likely to be non-neutralizable (5/12; 42%) than strong antibodies (OD>1.0; 4/23; 17%). 47 patients positive by ELISA were retested to determine the predominant immunoglobulin subclass. 15/47 (32%) were positive (OD>0.4) for IgG; 27/47 (57%) for IgM, and 12/47 (25%) for IgA. The Diamed assay more closely correlated with the GTI ELISA than the Akers test (82.1% vs. 56.7%, respectively). The PGIAs were only moderately correlated with each other (64%) with the Akers assay giving more “false positive” results relative to the ELISA. PMP were higher in patients with a positive ELISA (6.2 vs 4.7 × 106/ml) or positive SRA (5.5 vs. 5.1 ×106/ml) but this was not statistically significant due to the wide range of results. Of 119 patients assessed, 87 had a low pre-test probability of HIT (4-T score 0–3), 27 had an intermediate probability (4–5), and 5 had a high probability (6–8). The GTI ELISA was positive in 24, 56 and 80% of low, intermediate and high probability cases. The Akers PGIA was positive in 39, 41 and 40% respectively; the Diamed assay in 21, 33 and 40%, and the SRA in 7, 11 and 40%, respectively. This study was conducted in a patient population biased towards cardiovascular surgery, and confirms previously reported observations that immunoassays are more frequently positive than functional assays. The ELISA correlated better than the PGIA tests with the pre-test probability of HIT, although the Diamed test showed acceptable correlation with the ELISA. In contrast, the Akers assay correlated poorly with the ELISA, often producing positive results when the latter test was negative. We conclude that while the PGIA tests are rapid and convenient, further studies are needed to determine the basis for disparate results relative to the widely used ELISA.
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Muvunyi, Claude, Laurens Claeys, Tineka De Sutter, Petra De Sutter, Marleen Temmerman, Lieve Van Renterghem, Geert Claeys, and Elizaveta Padalko. "Comparison of four serological assays for the diagnosis of Chlamydia trachomatis in subfertile women." Journal of Infection in Developing Countries 6, no. 05 (November 30, 2011): 396–402. http://dx.doi.org/10.3855/jidc.1740.

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Introduction: Chlamydia antibody testing (CAT) in serum has been introduced as a screening method in the infertility workup. We evaluated the test characteristics of two ELISA tests compared to micro-immunofluorescence tests (MIFs). MIFs are considered the gold standard in the C. trachomatis IgG antibodies detection. We also compared the accuracy of all CAT tests in predicting tubal subfertility, using laparoscopy as a reference. Methodology: Four commercial serological methods were used to analyse 101 serum samples for the presence of C. trachomatis IgG antibodies from patients at the Infertility Clinic of Ghent University Hospital. The diagnostic utility for prediction of tubal infertility of serological methods was evaluated based on patients' medical records. Results: A comparison of the serological assays showed little difference in the major performance characteristics: the sensitivities of all MIFs and ELISAs were 100% for all assays (except the ELISA Vircell, with a sensitivity of 90%), and the specificities ranged from 92% for MIF Ani Labsystems to 98% for the MIF Focus and ELISA Vircell. As compared to laparoscopy data, CAT positivity in subfertile women with tubal damage (n=40) did not significantly differ from that of subfertile women without tubal damage (n=61): Positive predictive values (PPV) of CAT ranged from 53% to 60% and negative predictive values (NPV) ranged from 62% to 64%. Conclusion: evaluated ELISAs are comparable to MIFs in the detection of C. trachomatis IgG antibodies and should be preferred for large serological studies, especially in resource poor settings.
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Villa-Mancera, Abel, Pedro Molina-Mendoza, Karina Hernández-Guzmán, Jaime Olivares-Pérez, Jorge Sarracent-Pérez, and José Zumaquero-Ríos. "Comparative Diagnosis of Serum IgG1 and Coproantigen ELISA for Fasciolosis Detection of Goats in Mexico." BioMed Research International 2016 (2016): 1–7. http://dx.doi.org/10.1155/2016/3860928.

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The objective of present study was to determine the prevalence of natural caprine fasciolosis in the Mixteca region of Mexico using coproantigen and serum IgG1 ELISA tests for comparative purposes. A total of 1070 serum and faecal samples were analyzed for IgG1 antibodies and coproantigens, using ELISA with E/S products as antigen and a monoclonal antibody-based sandwich ELISA. Prevalence of 73.46% was found using the serological ELISA and a percentage of 77.20 was found for coproantigen ELISA. The diagnostic sensitivity and specificity for serum ELISA were 86.7% and 96.4%, and for the coproantigen ELISA they were 93.1% and 97.8%, respectively. The seropositive samples were further categorized as low, medium, or high positivity. Results show a great proportion of low and medium positive goats when the serum ELISA test was used. Correlation coefficients between coproantigens and seropositivity were statistically significant (P<0.01) for low seropositivity (r=0.93) and medium seropositivity (r=0.84). The accuracy of faecal antigen ELISA was higher compared to indirect ELISA serological test. Two ELISAs were shown to be useful for demonstrating the current status ofF. hepaticainfection in the endemic areas and can be employed in studies on epidemiology as well as anthelmintics treatment for preventing economic loss and the risk of transmission to humans.
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47

Bezerra, A. C., M. C. Barros, P. Loureiro, G. B. Medeiros, J. LO Magalhães, S. B. Barreto, M. DF Magno, M. BA Pinto, and W. Rocha. "COMPARISON OF ELISA TESTS IN THE SCREENING OF BLOOD DONORS." Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 20, no. 4 (April 1999): A67. http://dx.doi.org/10.1097/00042560-199904010-00250.

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48

Ibarra, Froylán, Natividad Montenegro, Yolanda Vera, Chantal Boulard, Hector Quiroz, Jaime Flores, and Pedro Ochoa. "Comparison of three ELISA tests for seroepidemiology of bovine fascioliosis." Veterinary Parasitology 77, no. 4 (June 1998): 229–36. http://dx.doi.org/10.1016/s0304-4017(98)00111-3.

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Ivanov, Alexander, Eugenia Dragunsky, Olga Ivanova, Gennady Rezapkin, Svetlana Potapova, and Konstantin Chumakov. "Determination of poliovirus-specific IgA in saliva by ELISA tests." Journal of Virological Methods 126, no. 1-2 (June 2005): 45–52. http://dx.doi.org/10.1016/j.jviromet.2005.01.030.

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50

Sutehall, G. M., and T. G. Wreghitt. "False positive latex tests negative by ELISA for toxoplasma IgG." Journal of Clinical Pathology 42, no. 2 (February 1, 1989): 204–5. http://dx.doi.org/10.1136/jcp.42.2.204.

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