Clinical performance of the Multispot HIV-1/HIV-2 rapid test to correctly differentiate HIV-2 from HIV-1 infection in screening algorithms using third and fourth generation assays and to identify cross reactivity with the HIV-1 Western Blot

ABSTRACT The rapid confirmatory Bio-Rad Geenius HIV 1/2 assay was evaluated as an alternative to the HIV-1 Western blot (WB) confirmatory assay. A total of 370 retrospective samples collected from 356 patients were tested. Sensitivity of the Geenius assay to detect HIV-1 and HIV-2 infections was 100% and 97%, respectively, and that of the WB assay was 86% and 39%, respectively. Geenius reduced the number of indeterminate results by 85% and exhibited a differentiation capacity for HIV-1 and HIV-2 of 100% and 89%, respectively. Three of 10 patients presenting with an early HIV infection (1 to 2 weeks before seroconversion by WB) were positive using Geenius. None of the HIV-negative samples were positive using Geenius or WB. However, 7% and 10% of them were indeterminate with Geenius and WB, respectively, leading to a specificity rate of 93% for Geenius and 90% for WB. Ninety cadaveric samples (54 negative, 23 HIV-1 positive, and 3 HIV-1 indeterminate) were tested with Geenius, leading to a sensitivity of 100%, a specificity of 96%, and an indeterminate rate of 4%. Our results indicate that the Bio-Rad Geenius HIV 1/2 rapid test exhibits better sensitivity to detect HIV-1 infections and better performance than WB to confirm and differentiate between HIV-1 and HIV-2 infections. The performance of this new confirmatory assay to detect early infections, to reduce the rate of indeterminate status, and to confirm HIV-1 infection in cadaveric blood samples makes Geenius a potent reliable alternative to the WB.

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Analytical and Clinical Performance of an Improved Qualitative Troponin T Rapid Test in Laboratories and Critical Care Units

Archives of Pathology & Laboratory Medicine ◽

10.5858/2000-124-0583-aacpoa ◽

2000 ◽

Vol 124 (4) ◽

pp. 583-587 ◽

Cited By ~ 1

Author(s):

Michael M. Hirschl ◽

Harald Herkner ◽

Anton N. Laggner ◽

Christer Sylvén ◽

Gundars Rasmanis ◽

...

Keyword(s):

Critical Care ◽

Clinical Performance ◽

Troponin T ◽

Rapid Test ◽

Cross Reactivity ◽

Enzyme Linked Immunosorbent Assay ◽

Critical Care Units ◽

Hospital Units ◽

Risk Patients ◽

Coronary Syndromes

Abstract Objective.—To evaluate the performance of a visual troponin T rapid test in the hands of nontraditionally trained personnel of 2 critical care units in comparison to 3 laboratories. Methods.—Method comparisons of the troponin T rapid test versus cardiac troponin T enzyme-linked immunosorbent assay were performed with 804 samples from 510 patients with suspected acute coronary syndromes. Cross-reactivity with skeletal troponin T was studied up to 5000 μg/L. Results.—Laboratories and critical care units obtained comparable results in the analytical cutoff of the test (0.11 and 0.10 μg/L) and in the diagnostic sensitivities in the detection of acute myocardial infarction (96% and 93% after 8 hours) and of high-risk patients with unstable angina pectoris (100% and 100%). Different percentages of false-positive results (0.2% and 3%) were found, which may reflect different objectives and strategies in these hospital units. The cross-reactivity with skeletal troponin T was less than 0.01%. Conclusions.—The troponin T rapid test gives reliable results not only when used by laboratory personnel experienced in the execution of analytical methods, but also in the hands of nurses and physicians working in clinical units outside the laboratory.

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Comparison of alternative interpretive criteria for the HIV-1 Western blot and results of the Multispot HIV-1/HIV-2 Rapid Test for classifying HIV-1 and HIV-2 infections

Journal of Clinical Virology ◽

10.1016/j.jcv.2011.09.020 ◽

2011 ◽

Vol 52 ◽

pp. S23-S27 ◽

Cited By ~ 16

Author(s):

Muazzam Nasrullah ◽

Steven F. Ethridge ◽

Kevin P. Delaney ◽

Laura G. Wesolowski ◽

Timothy C. Granade ◽

...

Keyword(s):

Western Blot ◽

Rapid Test ◽

Hiv 1

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Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection

American Journal of Clinical Pathology ◽

10.1093/ajcp/aqaa221 ◽

2020 ◽

Author(s):

Clarence W Chan ◽

Sajid Shahul ◽

Cheyenne Coleman ◽

Vera Tesic ◽

Kyle Parker ◽

...

Keyword(s):

Clinical Performance ◽

Reference Sample ◽

Rapid Test ◽

Antibody Test ◽

Cross Reactivity ◽

Antibody Detection ◽

Antibody Assay ◽

Widespread Application ◽

Global Pandemic ◽

Polymerase Chain

Abstract Objectives To evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test. Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic. However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore, rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation. Methods The Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set. Results The Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%. Conclusions The Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.

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Poor Performance of the Determine HIV-1/2 Ag/Ab Combo Fourth-Generation Rapid Test for Detection of Acute Infections in a National Household Survey in Swaziland

Journal of Clinical Microbiology ◽

10.1128/jcm.01989-14 ◽

2014 ◽

Vol 52 (10) ◽

pp. 3743-3748 ◽

Cited By ~ 39

Author(s):

Y. T. Duong ◽

Y. Mavengere ◽

H. Patel ◽

C. Moore ◽

J. Manjengwa ◽

...

Keyword(s):

Rapid Test ◽

Poor Performance ◽

Household Survey ◽

Fourth Generation ◽

Acute Infections ◽

National Household Survey ◽

Hiv 1

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ENVELOPE CROSS-REACTIVITY IN WESTERN BLOT FOR HIV-1 AND HIV-2 MAY NOT INDICATE DUAL INFECTION

The Lancet ◽

10.1016/s0140-6736(88)92598-6 ◽

1988 ◽

Vol 332 (8617) ◽

pp. 927-930 ◽

Cited By ~ 40

Author(s):

R.S Tedder ◽

A Hughes ◽

T Corrah ◽

T O'Connor ◽

H N'JIE ◽

...

Keyword(s):

Western Blot ◽

Dual Infection ◽

Cross Reactivity ◽

Hiv 1

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Post-Study Point-of-Care Oral Fluid Testing in HIV-1 Vaccinees

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa606 ◽

2020 ◽

Author(s):

Karina Oganezova ◽

Elvin J Fontana-Martinez ◽

Jon A Gothing ◽

Alisha Pandit ◽

Esther Kwara ◽

...

Keyword(s):

Diagnostic Tests ◽

Oral Fluid ◽

Point Of Care ◽

Antibody Test ◽

Cross Reactivity ◽

Fourth Generation ◽

Hiv Screening ◽

Hiv Test ◽

Hiv 1

Abstract Background Experimental HIV-1 vaccines frequently elicit antibodies against HIV-1 which may react with commonly used HIV diagnostic tests, a phenomenon known as vaccine-induced seropositivity/seroreactivity (VISP/VISR). We sought to determine under clinic conditions if a patient-controlled HIV test, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, detected HIV-1 vaccine-induced antibodies. Methods Plasma assessment of HIV-1 cross-reactivity was examined in end-of-study samples from 57 healthy, HIV-uninfected participants who received a candidate vaccine which has entered Phase 2B and 3 testing. We also screened 120 healthy, HIV-uninfected, unblinded HIV-1 vaccine participants with VISP/VISR for an assessment using saliva. These participants came from 21 different parent vaccine protocols representing 17 different vaccine regimens, all of which contained an HIV-1 envelope immunogen. OraQuick ADVANCE was compared to results from concurrent blood samples using a series of commercial HIV screening immunoassays. Results Fifty-seven unique participant plasma samples were assayed in vitro and only one (1.8%) was reactive by OraQuick ADVANCE. None of the 120 clinic participants (0%, [95% CI 0% to 3.7%]) tested positive by OraQuick ADVANCE and all were confirmed to be uninfected by HIV-1 viral RNA testing. 118 of the 120 (98.3%) participants had a reactive HIV test for VISP/VISR: 77 (64%) had at least one reactive fourth-generation HIV-1 diagnostic test (p<0.0001 vs no reactive OraQuick ADVANCE results) and 41 (34%) only had a reactive test by the less specific third-generation Abbott Prism assay. Conclusion These data suggest that this widely available patient-controlled test has limited reactivity to HIV-1 antibodies elicited by these candidate HIV-1 vaccines.

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Evaluation of the Bio-Rad Multispot HIV-1/HIV-2 Rapid Test as an alternative to Western blot for confirmation of HIV infection

Journal of Clinical Virology ◽

10.1016/j.jcv.2013.08.021 ◽

2013 ◽

Vol 58 ◽

pp. e97-e103 ◽

Cited By ~ 14

Author(s):

Ana María Cárdenas ◽

Eleonore Baughan ◽

Richard L. Hodinka

Keyword(s):

Hiv Infection ◽

Western Blot ◽

Rapid Test ◽

Hiv 1

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HIV-1/2 differentiation in a South African public laboratory

Southern African Journal of HIV Medicine ◽

10.4102/sajhivmed.v22i1.1185 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Rendani T. Mafuyeka ◽

Lynne M. Webber ◽

Piet Becker ◽

Simnikiwe H. Mayaphi

Keyword(s):

Human Immunodeficiency Virus ◽

South African ◽

Cross Reactivity ◽

Fourth Generation ◽

Rapid Assay ◽

Immunodeficiency Virus ◽

Testing Algorithm ◽

Public Laboratory ◽

Hiv 1 ◽

Human Immunodeficiency Virus 1

Background: The human immunodeficiency virus type-2 (HIV-2) prevalence in South Africa (SA) is unknown, however, sporadic cases have been reported. Human immunodeficiency virus -1 and 2 differentiation is not part of most South African public laboratories’ testing algorithm. Human immunodeficiency virus -2 diagnosis using serology assays may be complicated by HIV-1 and HIV-2 antibody cross-reactivity.Objectives: To determine the proportion of HIV-2 infections in specimens that tested HIV-1/2 positive at a public laboratory in Tshwane.Method: A total of 480 specimens that were previously tested with fourth generation ELISA platforms (Modular E170 [Roche, Switzerland] and Architect i2000 [Abbott, Germany]) were randomly selected. Human immunodeficiency virus -1 and 2 antibody differentiation testing was carried out using the Multispot HIV-1/2 rapid assay (Bio-Rad Laboratories, USA). An in-house nested HIV-2 PCR assay targeting the 5′-long terminal repeats (5′-LTR) region was evaluated and used as a confirmatory test.Results: The study tested 480 HIV-1/2 seropositive patients and their mean age was 36.7 years (range 3–82 years). Of the 480 patients, 292 (60.8%) were female, 182 (37.9%) were male and 6 (1.3%) were not specified. Human immunodeficiency virus differentiation results were as follows: 466 (97.1%) were positive for only HIV-1 antibodies, 11 (2.3%) [95%CI: (0.98%; 3.74%)] were positive for both HIV-1 and HIV-2 antibodies, 3 (0.6%) were negative for both antibodies and none were positive for only HIV-2 antibodies. Of the 11 specimens with both HIV-1 and HIV-2 antibodies, seven had sufficient volume for confirmatory testing and were all negative on the in-house HIV-2 PCR assay.Conclusion: The multispot HIV-1/2 rapid assay demonstrated cross-reactivity between HIV-1 and HIV-2 antibodies. Human immunodeficiency virus -2 infections were not detected.

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Potential for false-positive HIV test results using rapid HIV testing algorithms

African Journal of Laboratory Medicine ◽

10.4102/ajlm.v4i1.178 ◽

2015 ◽

Vol 4 (1) ◽

Cited By ~ 3

Author(s):

Rosemary A. Audu ◽

Rosemary N. Okoye ◽

Chika K. Onwuamah ◽

Fehintola A. Ige ◽

Adesola Z. Musa ◽

...

Keyword(s):

Western Blot ◽

False Positive ◽

Scale Up ◽

Rapid Test ◽

Test Results ◽

Rapid Testing ◽

Hiv Test ◽

Hiv Counselling And Testing ◽

Testing Algorithm ◽

Hiv 1

Background: In order to scale up access to HIV counselling and testing in Nigeria, an HIV diagnostic algorithm based on rapid testing was adopted. However, there was the need to further evaluate the testing strategy in order to better assess its performance, because of the potential for false positivity.Objectives: The objective of this study was to compare positive HIV test results obtained from the approved rapid testing algorithm with results from western blot tests performed on samples from the same patient.Methodology: A retrospective review was conducted of HIV screening and confirmatory results for patients seen between 2007 and 2008. Rapid test and western blot results were extracted and compared for concordance. Discordant results were further reviewed using a combination of HIV-1 RNA viral load and CD4+ cell count test results and clinical presentation from medical records.Results: Analysis of 2228 western blot results showed that 98.3% (n = 2191) were positive for HIV-1, 0.4% (n = 8) were positive for HIV-2 and 0.3% (n = 7) were dual infections (positive for both HIV-1 and HIV-2); 0.6% (n = 13) were indeterminate and 0.4% (n = 9) were negative. Further investigation of the 13 indeterminate results showed nine to be HIV-1 positive and four to be HIV-negative, for a total of 13 negative results. The positive predictive value of the HIV counselling and testing algorithm was 99.4%.Conclusion: Using the rapid testing algorithm alone, false positives were detected. Therefore, effective measures such as training and retraining of staff should be prioritised in order to minimise false-positive diagnoses and the associated potential for long-term psychological and financial impact on the patients.

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