scholarly journals Bicentric Evaluation of Six Anti-Toxoplasma Immunoglobulin G (IgG) Automated Immunoassays and Comparison to the Toxo II IgG Western Blot

2009 ◽  
Vol 16 (9) ◽  
pp. 1322-1326 ◽  
Author(s):  
Arnaud Maudry ◽  
Gautier Chene ◽  
Rémi Chatelain ◽  
Hugues Patural ◽  
Bahrie Bellete ◽  
...  

ABSTRACT A comparative study of the Toxoplasma IgGI and IgGII Access (Access I and II, respectively; Beckman Coulter Inc.), AxSYM Toxo IgG (AxSYM; Abbott Diagnostics), Vidas Toxo IgG (Vidas; bioMerieux, Marcy l'Etoile, France), Immulite Toxo IgG (Immulite; Siemens Healthcare Diagnostics Inc.), and Modular Toxo IgG (Modular; Roche Diagnostics, Basel, Switzerland) tests was done with 406 consecutive serum samples. The Toxo II IgG Western blot (LDBio, Lyon, France) was used as a reference technique in the case of intertechnique discordance. Of the 406 serum samples tested, the results for 35 were discordant by the different techniques. Using the 175 serum samples with positive results, we evaluated the standardization of the titrations obtained (in IU/ml); the medians (second quartiles) obtained were 9.1 IU/ml for the AxSYM test, 21 IU/ml for the Access I test, 25.7 IU/ml for the Access II test, 32 IU/ml for the Vidas test, 34.6 IU/ml for the Immulite test, and 248 IU/ml for the Modular test. For all the immunoassays tested, the following relative sensitivity and specificity values were found: 89.7 to 100% for the Access II test, 89.7 to 99.6% for the Immulite test, 90.2 to 99.6% for the AxSYM test, 91.4 to 99.6% for the Vidas test, 94.8 to 99.6% for the Access I test, and 98.3 to 98.7% for the Modular test. Among the 406 serum samples, we did not find any false-positive values by two different tests for the same serum sample. Except for the Modular test, which prioritized sensitivity, it appears that the positive cutoff values suggested by the pharmaceutical companies are very high (either for economical or for safety reasons). This led to imperfect sensitivity, a large number of unnecessary serological follow-ups of pregnant women, and difficulty in determining the serological status of immunosuppressed individuals.

2000 ◽  
Vol 38 (7) ◽  
pp. 2628-2632 ◽  
Author(s):  
Marta A. Guerra ◽  
Edward D. Walker ◽  
Uriel Kitron

Serum samples obtained from healthy, asymptomatic dogs in areas of Wisconsin and northern Illinois where Lyme disease is endemic or nonendemic were assayed for antibodies to Borrelia burgdorferi by enzyme-linked immunosorbent assay (ELISA), and positive results were confirmed by immunoblot assay. We found that 56.9% (562 of 1,077) of the samples were positive by ELISA and 82.0% (461 of 562) were positive by immunoblotting. A logistic regression model was developed to distinguish between nonvaccinated dogs naturally infected with B. burgdorferi from areas where the disease is endemic and dogs from areas where the disease is nonendemic that were vaccinated against Lyme disease. Of the 18 protein bands analyzed, 8 were found to be significantly different (P < 0.05) between the two groups. p93, p34, p31, and p28 occurred with increased frequency in vaccinated dogs, while p58, p37, p35, and p30 occurred more frequently in naturally infected dogs. The logistic regression equation obtained was used to determine the probability of natural infection among vaccinated dogs residing in areas where the disease is endemic. Of 125 samples, 87.2% had a very low probability of natural infection and only 2.4% were highly likely to be infected. Logistic regression is a useful method for distinguishing between vaccinated and naturally infected dogs and predicting the serological status of vaccinated dogs from areas where Lyme disease is endemic.


1994 ◽  
Vol 40 (10) ◽  
pp. 1944-1949 ◽  
Author(s):  
S H Mishalani ◽  
J Seliktar ◽  
G D Braunstein

Abstract We evaluated the performance of four visually read pregnancy tests (TestPack Plus hCG Combo, ICON II hCG, SureCell hCG-Serum/Urine and PregnaGen 1-Step) designed to detect increased concentrations of choriogonadotropin (hCG) in either serum or urine samples. The biochemical sensitivities and specificity in both serum and urine samples were similar for each kit. All kits correctly identified pregnancy serum samples: The TestPack Plus hCG Combo and SureCell hCG-Serum/Urine were 100% specific; the other two kits exhibited a few false-positive results. For urine samples the ICON II hCG test was 100% sensitive, and the other three were 99.5% sensitive, with false-positive urine results occasionally reported by the PregnaGen 1-Step and ICON II hCG tests. Quantitative hCG concentrations could be estimated in pregnancy serum samples, but not urine samples, through determination of the time elapsed from the sample application or addition of the final reagent to the first appearance of a positive result.


1964 ◽  
Vol 62 (2) ◽  
pp. 179-184 ◽  
Author(s):  
Alexander L. Terzin

Complement-fixation tests with psittacosis-trachoma group antigens, if set up with complement prepared from guinea-pigs cross-infected with any of the Bedsonia agents, may give completely false positive results. The use of C.F. positive or C.F. inhibition positive samples of guinea-pig sera as a source of complement can induce also a significant increase or decrease, respectively, of the actual C.F. titres in Bedsonia-positive serum samples tested. Observations made both in routine serology and in experimental studies show the necessity of testing carefully, for possible presence of Bedsonia titres, individual sera of guinea-pigs intended for use as source of complement in C.F. tests performed with Bedsonia group antigens.I have pleasure in thanking Dr F. B. Gordon and Dr E. Weiss for the valuable suggestions made and HM3 C.O. Wiese for the technical assistance.


2016 ◽  
Vol 41 (6) ◽  
Author(s):  
Eren Vurgun ◽  
Osman Evliyaoğlu ◽  
Sembol Yıldırmak ◽  
İbrahim Akarsubaşı

AbstractObjective:We aimed to find out whether there is significant carryover effect which causes false-positive hematuria on red blood cells (RBCs) in automatic urine chemistry (DIRUI H-800) and sediment (DIRUI FUS-200) analyzers.Methods:Twenty-four samples with gross hematuria selected as containing high RBC concentration and forty-eight samples which had both negative result in dipstick and 0/hpf in microscopic examination selected as containing low RBC concentration. Carryover% was calculated via the formula [carryover%=100×(bResults:Carryover% was very high (67%) in urine chemistry analyzer. Carryover% of urine sediment analyzer was found 0.4% whilst false-positive hematuria percentage was 87.5% for the first samples came after gross hematuria and 6.6% for the second samples. The first samples analyzed after gross hematuria had significantly higher (p<0.001) results than the second samples in both analyzers.Conclusion:In urine sediment analyzer, carryover% calculated by formula was found analytically sufficient, but it causes highly false-positive results due to diagnostic limit of hematuria (RBC>3/hpf) is low. To prevent carryover in both urine analyzers; washing procedures should be revised and the diagnostic effect of carryover should also be taken into account by biochemists.


Author(s):  
Himadri Nath ◽  
Abinash Mallick ◽  
Subrata Roy ◽  
Soumi Sukla ◽  
Keya Basu ◽  
...  

AbstractFive of thirteen Dengue antibody-positive serum samples, dated 2017 (pre-dating the COVID-19 outbreak) produced false-positive results in SARS-CoV-2 IgG/IgM rapid strip tests. Our results emphasize the importance of NAT and/or virus antigen tests to complement sero-surveillance for definitive diagnosis of COVID-19/Dengue in regions where both viruses are co-endemic.


2021 ◽  
Vol 70 (6) ◽  
Author(s):  
Himadri Nath ◽  
Abinash Mallick ◽  
Subrata Roy ◽  
Soumi Sukla ◽  
Keya Basu ◽  
...  

Co-endemicity of SARS-CoV-2 and dengue virus (DV) infection is becoming a matter of serious concern as it has been already reported that antibodies (Ab) elicited by SARS-CoV-2 infection can produce false-positive results in dengue IgG and IgM rapid tests and vice versa. Here we communicate that five of thirteen DV antibody-positive serum samples from Kolkata, archived in 2017 (predating the COVID-19 outbreak), produced false-positive results in SARS-CoV-2 IgG/IgM lateral flow-based rapid tests. Our results emphasize the importance of implementing tests with higher specificity to conduct sero-surveillance for accurate estimation of SARS-CoV-2/DV prevalence in regions where both viruses now co-exist.


2002 ◽  
Vol 63 (10) ◽  
pp. S102
Author(s):  
Jeremy Goodman ◽  
Martin D Jendrisak ◽  
Surendra Shenoy ◽  
Jeffrey A Lowell ◽  
T Mohanakumar

2020 ◽  
Vol 58 (4) ◽  
Author(s):  
Caleb Skipper ◽  
Kiiza Tadeo ◽  
Emily Martyn ◽  
Elizabeth Nalintya ◽  
Radha Rajasingham ◽  
...  

ABSTRACT Early cryptococcal disease can be detected via circulating antigen in blood before fulminant meningitis develops, when early antifungal therapy improves survival. Two semiquantitative cryptococcal antigen (CrAg) lateral flow assays (LFAs) have been developed, but their diagnostic performance has not been defined. Cryopreserved serum samples from HIV-infected Ugandans obtained as part of a prospective CrAg-screening cohort were tested in duplicate for CrAg by the CrAgSQ (IMMY) and CryptoPS (Biosynex) lateral flow assays. Case-controlled diagnostic performance was measured using the FDA-approved CrAg LFA (IMMY) as a reference standard via McNemar’s test. Of 99 serum samples tested, 57 were CrAg positive (CrAg+) by the CrAg LFA reference standard. By CrAgSQ, 57 were read as positive, with 98% sensitivity (56/57; 95% confidence interval [CI], 0.91 to 0.99) and 98% specificity (41/42; 95% CI, 0.88 to 0.99) (McNemar’s, P = 0.99). The sample with a false-negative result by CrAgSQ (n = 1) had a titer of <1:5, while the sample with a false-positive result (n = 1) yielded a 1+ result. By CryptoPS, 52 samples were read as positive, with 88% sensitivity (50/57; 95% CI, 0.76 to 0.95) and 95% specificity (40/42; 95% CI, 0.84 to 0.99) (McNemar’s, P = 0.18). The CryptoPS false-negative results included samples with titers of <1:5 (n = 1), 1:5 (n = 5), and 1:20 (n = 1), while samples with false-positive results by CryptoPS (n = 2) yielded Positive results. The CryptoPS assay missed 35% (7/20) of samples with CrAg LFA titers of ≤1:20. The new semiquantitative CrAg LFAs allow rapid estimation of titer levels in easy-to-perform platforms. The CrAgSQ demonstrated better qualitative sensitivity and specificity than the CryptoPS compared to the reference standard. The exact grading of the CrAgSQ results has some subjectivity, with interreader variability; however, qualitative reads were generally concordant for both assays.


2006 ◽  
Vol 13 (3) ◽  
pp. 409-414 ◽  
Author(s):  
Mimoun Maache ◽  
Florence Komurian-Pradel ◽  
Alain Rajoharison ◽  
Magali Perret ◽  
Jean-Luc Berland ◽  
...  

ABSTRACT To evaluate the reactivity of the recombinant proteins expressed in Escherichia coli strain BL21(DE3), a Western blot assay was performed by using a panel of 78 serum samples obtained, respectively, from convalescent-phase patients infected with severe acute respiratory syndrome-associated coronavirus (SARS-CoV) (30 samples) and from healthy donors (48 samples). As antigen for detection of SARS-CoV, the nucleocapsid protein (N) showed high sensitivity and strong reactivity with all samples from SARS-CoV patients and cross-reacted with all serum samples from healthy subjects, with either those obtained from China (10 samples) or those obtained from France (38 serum samples), giving then a significant rate of false positives. Specifically, our data indicated that the two subunits, S1 (residues 14 to 760) and S2 (residues 761 to 1190), resulted from the divided spike reacted with all samples from SARS-CoV patients and without any cross-reactivity with any of the healthy serum samples. Consequently, these data revealed the nonspecific nature of N protein in serodiagnosis of SARS-CoV compared with the S1 and S2, where the specificity is of 100%. Moreover, the reported results indicated that the use of one single protein as a detection antigen of SARS-CoV infection may lead to false-positive diagnosis. These may be rectified by using more than one protein for the serodiagnosis of SARS-CoV.


2001 ◽  
Vol 47 (2) ◽  
pp. 308-315 ◽  
Author(s):  
Laurence A Cole ◽  
Shohreh Shahabi ◽  
Stephen A Butler ◽  
Hugh Mitchell ◽  
Edward S Newlands ◽  
...  

Abstract Background: Patients with trophoblastic diseases produce ordinary and irregular forms of human chorionic gonadotropin (hCG; e.g., nicked hCG, hCG missing the β-subunit C-terminal segment, hyperglycosylated hCG, and free β subunit) that are recognized to differing extents by automated immunometric hCG (or hCGβ) assays. This has led to low or false-negative results and misdiagnosis of persistent disease. False-positive hCG immunoreactivity has also been detected, leading to needless therapy for trophoblastic diseases. Here we compare seven commonly used hCG assays. Methods: Standards for five irregular forms hCG produced in trophoblastic diseases, serum samples from 59 patients with confirmed trophoblastic diseases, and serum samples from 12 women with previous false-positive hCG results (primarily in the Abbott AxSYM assay) were blindly tested by commercial laboratories in the Beckman Access hCGβ, the Abbott AxSYM hCGβ, the Chiron ACS:180 hCGβ, the Baxter Stratus hCG test, the DPC Immulite hCG test, the Serono MAIAclone hCGβ tests, and in the hCGβ RIA. Results: Only the RIA and the DPC appropriately detected the five irregular hCG standards. Only the Beckman, DPC, and Abbott assays gave results similar to the RIA in the patients with confirmed trophoblastic diseases (values within 25% of RIA in 49, 49, and 54 of 59 patients, respectively). For samples that were previously found to produce false-positive hCG results, no false-positive results were detected with the DPC and Chiron tests (5 samples, median &lt;2 IU/L), but up to one-third of samples were false positive (&gt;10 IU/L) in the Beckman (1 of 5), Serono (2 of 9), and Baxter assays (1 of 5), and the hCGβ RIA (3 of 9; median for all assays, &lt;5 IU/L). These samples, which produced false-positive results earlier in the Abbott AxSYM assay, continued to produce high values upon reassessment (median, 81 IU/L). Conclusions: Of six frequently used hCG immunometric assays, only the DPC detected the five irregular forms of βhCG, agreed with the RIA, and avoided false-positive results in the samples tested. This assay, and similarly designed assays not tested here, seem appropriate for hCG testing in the diagnosis and management of trophoblastic diseases.


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