Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentiation assay for CLSI M53 algorithm-I

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
L MallochJ Kim

Abstract

The CLSI-M53-A, Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus (HIV) Infection; Approved Guideline includes an algorithm in which samples that are reactive on a 4th generation EIA screen proceed to a supplemental assay that is able to confirm and differentiate between antibodies to HIV-1 and HIV-2. The recently CE-marked Bio-Rad Geenius HIV-1/2 Confirmatory Assay was evaluated as an alternative to the FDA-approved Bio-Rad Multispot HIV-1/HIV-2 Rapid Test which has been previously validated for use in this new algorithm. This study used reference samples submitted to the Canadian - NLHRS and samples from commercial sources. Data was tabulated in 2×2 tables for statistical analysis; sensitivity, specificity, predictive values, kappa and likelihood ratios. The overall performance of the Geenius and Multispot was very high; sensitivity (100%, 100%), specificity (96.3%, 99.1%), positive (45.3, 181) and negative (0, 0) likelihood ratios respectively, high kappa (0.96) and low bias index (0.0068). The ability to differentiate HIV-1 (99.2%, 100%) and HIV-2 (98.1%, 98.1%) Ab was also very high. The Bio-Rad Geenius HIV-1/2 Confirmatory Assay is a suitable alternative to the validated Multispot for use in th...Continue Reading

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References

Mar 26, 2011·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Bernard M Branson
Oct 11, 2011·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Silvina MasciotraS Michele Owen
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Citations

Sep 7, 2014·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Lakshmi ChandramohanPaula A Revell
Jun 17, 2014·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Isabel MontesinosMarie-Luce Delforge
Dec 3, 2014·Enfermedades infecciosas y microbiología clínica·Marta Álvarez EstévezFederico García García
Jul 31, 2014·Journal of Virological Methods·Natacha HerssensKatrien Fransen
Jul 20, 2014·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·I AbbateM R Capobianchi
Mar 5, 2016·Clinical and Vaccine Immunology : CVI·Thomas S Alexander
Jun 20, 2014·Clinical and Vaccine Immunology : CVI·Anne Hawthorne HallenGordana Bogdanovic
Jul 28, 2017·Journal of Clinical Microbiology·Cara S KosackAnne-Laure Page
Nov 30, 2018·Clinical Microbiology Reviews·Bharat S ParekhJohn N Nkengasong
Jan 24, 2020·MMWR. Morbidity and Mortality Weekly Report·Anne H PeruskiM Patricia Joyce
Jul 7, 2020·Clinical Chemistry·Bijal A Parikh, Neil W Anderson
Sep 26, 2020·Access Microbiology·S J ShepherdR N Gunson
Apr 8, 2021·Southern African Journal of HIV Medicine·Rendani T MafuyekaSimnikiwe H Mayaphi

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