Comparison of the Cepheid GeneXpert and Abbott M2000 HIV-1 real time molecular assays for monitoring HIV-1 viral load and detecting HIV-1 infection

Ceffa, Susanna; Luhanga, Richard; Andreotti, Mauro; Brambilla, Davide; Erba, Fulvio; Jere, Haswel; Giuliano, Marina; Palombi, Leonardo; Marazzi, Maria Cristina

doi:10.1016/j.jviromet.2015.12.007

Cited by 57 publications

(71 citation statements)

References 12 publications

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“…We observed a slight overestimation of viral load by the Xpert HIV-1 viral load assay, which is consistent with other studies (21)(22)(23)(24).…”

Section: Discussionsupporting

confidence: 92%

“…Despite the development of several POC viral load technologies over the last decade (14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24), there is a shortage of commercially available tests. In this study, we evaluated the performance of the POC Cepheid Xpert HIV-1 viral load test in rural communities in Botswana in order to provide additional data to policy makers regarding the use of this assay in decentralized HIV treatment programs.…”

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confidence: 99%

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Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable

et al. 2016

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“…We observed a slight overestimation of viral load by the Xpert HIV-1 viral load assay, which is consistent with other studies (21)(22)(23)(24).…”

Section: Discussionsupporting

confidence: 92%

mentioning

confidence: 99%

Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable

et al. 2016

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“…A study in Zimbabwean infants with a median age of 6.9 weeks revealed a sensitivity of 97% and specificity of 100%, while another study in Malawi of infants at 1 and 6 months of age revealed 100% sensitivity and specificity. 10,11 Nevertheless, our slightly reduced sensitivity at birth to 93.3% is consistent with similarly reduced sensitivities of other POC platforms in children less than 3 days of age. 15,16 …”

Section: Discussionsupporting

confidence: 84%

Brief Report: High Sensitivity and Specificity of the Cepheid Xpert HIV-1 Qualitative Point-of-Care Test Among Newborns in Botswana

Ibrahim

Moyo²,

Mohammed³

et al. 2017

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background HIV point-of-care (POC) testing allows for early infant HIV diagnosis and treatment, but POC accuracy at birth and in the setting of antiretroviral prophylaxis for the prevention of mother-to-child HIV transmission (MTCT) is unknown. Methods We evaluated the Cepheid Xpert® HIV-1 Qual POC test against the Roche Taqman HIV-1 PCR platform using dried blood spots from 15 HIV-infected and 75 HIV-exposed uninfected newborns. These infants were screened for HIV at <96 hours of life at 5 hospital maternity wards in Botswana; all infants received post-exposure antiretroviral prophylaxis (PEP) and most mothers received 3-drug antiretroviral therapy in pregnancy and at delivery. Results Fourteen of 15 PCR positive samples tested positive by Cepheid POC, yielding a sensitivity of 93.3% (95%CI: 68.1–99.8%). Baseline viral load among positive infants ranged from <40 to >10,000,000 copies/ml, with a median of 2,403 copies/mL. The HIV RNA for the infant with false negative POC testing was 1,661 copies/mL. Of note, two infants with low HIV RNA (< 40 copies/mL and 272 copies/ml) were correctly identified as HIV positive by Cepheid POC. All of the 75 PCR-negative samples tested negative by Cepheid POC, yielding a specificity of 100% (95% CI: 96.1 –100%). Discussion Our study demonstrates high sensitivity and specificity for the Cepheid POC assay in the first week of life despite early infection and antiretroviral prophylaxis. This platform may be a useful approach for adding early infant HIV diagnosis to current testing programs.

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“…Evaluation studies to date have reported good performance of the Xpert HIV-1 VL assay against existing technologies such as the Abbott HIV-1 RT and Aptima HIV Dx (Hologics®, Inc) on plasma [8–10] and therefore, warranted evaluation in the South African setting to consider criteria for implementation. This evaluation also included developing protocols for DBS and whole blood specimen types (for which the manufacturer has no claim), as well as development of a quality monitoring program to support potential VL implementation for all specimen types.…”

Section: Introductionmentioning

confidence: 99%

Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay

et al. 2016

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BackgroundExpansion of HIV viral load (VL) testing services are required to meet increased targets for monitoring patients on antiretroviral treatment. South Africa currently tests >4million VLs per annum in 16 highly centralised, automated high-throughput laboratories. The Xpert HIV-1 VL assay (Cepheid) was evaluated against in-country predicates, the Roche Cobas Taqmanv2 and Abbott HIV-1RT, to investigate options for expanding VL testing using GeneXpert’s random access, polyvalent capabilities and already established footprint in South Africa with the Xpert MTB/RIF assay (207 sites). Additionally, the performance of Xpert HIV-1VL on alternative, off-label specimen types, Dried Blood Spots (DBS) and whole blood, was investigated.MethodPrecision, accuracy (agreement) and clinical misclassification (1000cp/ml) of Xpert HIV-1VL plasma was compared to Taqmanv2 (n = 155) and Abbott HIV-1 RT (n = 145). Misclassification of Xpert HIV-1VL was further tested on DBS (n = 145) and whole blood (n = 147).ResultsXpert HIV-1VL demonstrated 100% concordance with predicate platforms on a standardised frozen, plasma panel (n = 42) and low overall percentage similarity CV of 1.5% and 0.9% compared to Taqmanv2 and Abbott HIV-1 RT, respectively. On paired plasma clinical specimens, Xpert HIV-1VL had low bias (SD 0.32–0.37logcp/ml) and 3% misclassification at the 1000cp/ml threshold compared to Taqmanv2 (fresh) and Abbott HIV-1 RT (frozen), respectively. Xpert HIV-1VL on whole blood and DBS increased misclassification (upward) by up to 14% with increased invalid rate. All specimen testing was easy to perform and compatible with concurrent Xpert MTB/RIF Tuberculosis testing on the same instrument.ConclusionThe Xpert HIV-1VL on plasma can be used interchangeably with existing predicate platforms in South Africa. Whole blood and DBS testing requires further investigation, but polyvalency of the GeneXpert offers a solution to extending VL testing services.

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Comparison of the Cepheid GeneXpert and Abbott M2000 HIV-1 real time molecular assays for monitoring HIV-1 viral load and detecting HIV-1 infection

Cited by 57 publications

References 12 publications

Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable

Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable

Brief Report: High Sensitivity and Specificity of the Cepheid Xpert HIV-1 Qualitative Point-of-Care Test Among Newborns in Botswana

Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay

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