title: 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.
abstract: Assessing treatment efficacy and early infant diagnosis (EID) are critical issues in HIV disease management. Point-of-care assays may greatly increase the possibility to access laboratory monitoring also in rural areas. Recently two new laboratory tests have been developed by Cepheid (Sunnyvale, California) the Xpert HIV-1 Viral Load for viral load determination and the Xpert HIV-1 Qualitative for early infant diagnosis. We conducted a study in Blantyre, Malawi, comparing the 2 methods versus the Abbott real time quantitative and qualitative assays, for viral load and EID respectively. We tested 300 plasma samples for viral load determination and 200 samples for infant diagnosis. HIV-1 RNA values of the 274 samples quantified by both assays were highly correlated (Pearson r=0.95, R(2)=0.90). In 90.9% of the cases the two methods were concordant in defining the HIV-1 RNA levels as detectable or undetectable. For EID, the Xpert HIV-1 Qualitative assay yielded the same identical results as the Abbott assay. Both the quantitative and the qualitative Xpert assays are promising tools to monitor treatment efficacy in HIV patients receiving treatment and for early diagnosis in HIV-exposed infants.
authors.affiliation: DREAM Program, Community of S. Egidio, via di San Gallicano 25, 00153 Rome, Italy.
authors.forename: Susanna
authors.initials: S
authors.lastname: Ceffa
authors.affiliation: DREAM Program, Community of S. Egidio, DREAM Health Center, Jacaranda Avenue P.O BOX 30355 Mandala Chichiri Blantyre 3, 265, Malawi.
authors.forename: Richard
authors.initials: R
authors.lastname: Luhanga
authors.affiliation: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Viale Regina Elena n.299, 00161 Rome, Italy. Electronic address: mauro.andreotti@iss.it.
authors.forename: Mauro
authors.initials: M
authors.lastname: Andreotti
authors.affiliation: DREAM Program, Community of S. Egidio, via di San Gallicano 25, 00153 Rome, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Brambilla
authors.affiliation: Department of Clinical Science and Translational Medicine, University of Rome Tor Vergata, via di Tor Vergata, Rome, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Erba
authors.affiliation: DREAM Program, Community of S. Egidio, DREAM Health Center, Jacaranda Avenue P.O BOX 30355 Mandala Chichiri Blantyre 3, 265, Malawi.
authors.forename: Haswel
authors.initials: H
authors.lastname: Jere
authors.affiliation: Department of Biomedicine and Prevention, University of Roma Tor Vergata, via Montpellier n.1, 00133 Rome, Italy.
authors.forename: Sandro
authors.initials: S
authors.lastname: Mancinelli
authors.affiliation: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Viale Regina Elena n.299, 00161 Rome, Italy.
authors.forename: Marina
authors.initials: M
authors.lastname: Giuliano
authors.affiliation: Department of Biomedicine and Prevention, University of Roma Tor Vergata, via Montpellier n.1, 00133 Rome, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Palombi
authors.affiliation: Department of Community Health, LUMSA University, Via Transpontina n.21, 00193 Rome, Italy.
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Marazzi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D016903:Drug Monitoring / Q000379:methods*; D042241:Early Diagnosis; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008295:Malawi; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012367:RNA, Viral / Q000097:blood; D019562:Viral Load / Q000379:methods*; D055815:Young Adult
chemical_list: D012367:RNA, Viral
keywords: Early infant diagnosis; HIV-1; POC tests; Viral load