HIV antibody screening remains indispensable for ensuring viral safety of blood components despite NAT implementation

Laperche, Syria; Morel, Pascal; Deschaseaux, Marie; Bouchardeau, Françoise; Alimardani, Gulie; Guillaume, Nicolas; Rouger, Philippe; Lefrère, Jean‐Jacques

doi:10.1046/j.1537-2995.2003.00541.x

Cited by 22 publications

(24 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These ECs have been identified among HIV-infected blood donors in several countries and the proportion varies between 1 and 4% depending on the sensitivity of the NAT screening systems employed. 19 None of these EC donations in South Africa had quantifiable viral load results in the Roche TaqMan dual target (LTR/gag) viral load assay, confirming that the Ultrio dual target (LTR/pol) assay did not fail to detect any strains of HIV-1. 20,21 In a considerable proportion (25%) of EC donors HIV-RNA could not be detected despite 10 to 33 replicate Ultrio assays.…”

Section: Discussionmentioning

confidence: 69%

Comparison of human immunodeficiency virus assays in window phase and elite controller samples: viral load distribution and implications for transmission risk

et al. 2013

View full text Add to dashboard Cite

BACKGROUND After 3 years of individual-donation nucleic acid test (ID-NAT) screening by the South African National Blood Service (SANBS), a repository of 73 human immunodeficiency virus antibody (anti-HIV)-negative window period (WP)-yield samples and 28 anti-HIV–positive, HIV-RNA–negative elite controllers (ECs) became available for comparison of a p24 antigen (p24 Ag) assay (Innogenetics), two viral load assays (Siemens branch DNA [bDNA] 3.0 and Abbott real-time polymerase chain reaction [RT-PCR]), and three triplex NAT assays (Novartis Diagnostics Ultrio and Ultrio-Plus and Roche TaqScreen) by replicate testing of dilutions. STUDY DESIGN AND METHODS Viral loads were assessed by bDNA and RT-PCR assays and if below 100 copies (cps)/mL, by Ultrio limiting dilution probit analysis. The probability of virus transmission by WP and EC donations was estimated for different levels of the 50% minimum infectious dose (ID50) using Poisson distribution statistics. RESULTS The equal distribution of WP donations plotted by log HIV-RNA levels indicated a random appearance of donors in the ramp-up phase. The HIV p24 Ag assay detected 45% of WP samples and the cutoff crossing point was estimated at 8140 (bDNA)/ 22,710 (RT-PCR) cps/mL. On replicate retesting of 40 HIV p24 Ag–negative ID-NAT WP-yield samples Ultrio minipool (MP)8, Ultrio-Plus MP8, and TaqScreen MP6 detected 79, 81, and 78%, respectively. Modeling with an estimated ID50 of 31.6 virions/RBC indicated that 15% of p24 Ag–negative ID-NAT WP-yield donations would have transmitted HIV if MP6–8 NAT had been used. Only 2% of RBC transfusions from ECs are estimated to be infectious with a worst-case ID50 estimate of 316 virions. CONCLUSION Our analysis of viremia and infectivity of WP and EC donations enables comparison of the efficacy of NAT options in preventing HIV transmission risk.

show abstract

Section: Discussionmentioning

confidence: 69%

Comparison of human immunodeficiency virus assays in window phase and elite controller samples: viral load distribution and implications for transmission risk

et al. 2013

View full text Add to dashboard Cite

show abstract

“…NAAT is an appealing addition in that it detects virus directly and uses technology that does not share features with the antibody tests. However, it is less sensitive for detection of established infection than the serologic tests (Table 1) (1,19,30,42). On the other hand, it is more sensitive than the serologic tests for early infection (Fig.…”

Section: Resultsmentioning

confidence: 99%

Alternative Algorithms for Human Immunodeficiency Virus Infection Diagnosis Using Tests That Are Licensed in the United States

et al. 2008

View full text Add to dashboard Cite

Serodiagnosis of human immunodeficiency virus (HIV) infection in the UnitedStates has traditionally relied on a sequential two-test algorithm: an initial screen with an enzyme immunoassay (EIA) and reflex testing of EIA-reactive specimens with a more specific supplemental test such as Western blotting or immunofluorescence. The supplemental tests are tedious, subjective, and expensive. In addition, there have been major improvements in the performance and accuracy of the EIA tests as well as the introduction of rapid serologic tests (RT) and HIV nucleic acid amplification tests (NAAT). Related to these improvements is the possibility that alternative algorithms using combinations of currently approved HIV tests may function as well as if not better than the current algorithm, with more flexibility, improved accuracy, and lower cost. To this end, we evaluated the performance of 12 currently licensed tests and 1 in-house HIV test (6 EIA, 4 RT, and 3 NAAT) on panels of plasma samples from HIV-infected (n ‫؍‬ 621 HIV type 1 [HIV-1] and 34 HIV-2) and uninfected (n ‫؍‬ 513) people and of sequential specimens from people early in seroconversion (183 specimens from 15 patients). Test combinations were analyzed in two dual-test (sensitivity-optimized and specificity-optimized) algorithms and in a three-test (tie-breaking) algorithm, and performance was compared to the conventional algorithm. The results indicate that alternative algorithm strategies with currently licensed tests compare favorably with the conventional algorithm in detecting and confirming established HIV infection. Furthermore, there was a lower frequency of discordant or indeterminate results that require follow-up testing, and there was improved detection of early infection.

show abstract

“…Assays are ranked on the basis of the total number of samples identified as reactive; results of these studies are published in the literature. Only the top-performing assays are recommended to laboratories for continued use [68,[89][90][91].…”

Section: The Three-legged Racementioning

confidence: 99%

HIV Testing Updates and Challenges: When Regulatory Caution and Public Health Imperatives Collide

Branson¹

2015

Curr HIV/AIDS Rep

View full text Add to dashboard Cite

Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV. Access to these developments, however, is often delayed by the regulatory apparatus for approval and oversight of HIV testing in the USA. This article summarizes recent developments in HIV diagnostic testing technology, outlines their implications for clinical management and public health, describes current systems of regulatory oversight for HIV testing in the USA, and proposes alternatives that could expedite access to improved tests as they become available.

show abstract

HIV antibody screening remains indispensable for ensuring viral safety of blood components despite NAT implementation

Abstract: The results clearly demonstrate that anti-HIV screening should not be withdrawn from biologic qualification procedures of blood donations, even when single NAT is performed.

Cited by 22 publications

References 24 publications

Comparison of human immunodeficiency virus assays in window phase and elite controller samples: viral load distribution and implications for transmission risk

Comparison of human immunodeficiency virus assays in window phase and elite controller samples: viral load distribution and implications for transmission risk

Alternative Algorithms for Human Immunodeficiency Virus Infection Diagnosis Using Tests That Are Licensed in the United States

HIV Testing Updates and Challenges: When Regulatory Caution and Public Health Imperatives Collide

Contact Info

Product

Resources

About