title: Field evaluation of Abbott Real Time HIV-1 Qualitative test for early infant diagnosis using dried blood spots samples in comparison to Roche COBAS Ampliprep/COBAS TaqMan HIV-1 Qual test in Kenya.
abstract: Timely diagnosis and treatment of infants infected with HIV are critical for reducing infant mortality. High-throughput automated diagnostic tests like Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Qual Test (Roche CAPCTM Qual) and the Abbott Real Time HIV-1 Qualitative (Abbott Qualitative) can be used to rapidly expand early infant diagnosis testing services. In this study, the performance characteristics of the Abbott Qualitative were evaluated using two hundred dried blood spots (DBS) samples (100 HIV-1 positive and 100 HIV-1 negative) collected from infants attending the antenatal facilities in Kisumu, Kenya. The Abbott Qualitative results were compared to the diagnostic testing completed using the Roche CAPCTM Qual in Kenya. The sensitivity and specificity of the Abbott Qualitative were 99.0% (95% CI: 95.0-100.0) and 100.0% (95% CI: 96.0-100.0), respectively, and the overall reproducibility was 98.0% (95% CI: 86.0-100.0). The limits of detection for the Abbott Qualitative and Roche CAPCTM Qual were 56.5 and 6.9copies/mL at 95% CIs (p=0.005), respectively. The study findings demonstrate that the Abbott Qualitative test is a practical option for timely diagnosis of HIV in infants.
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: ckc7@cdc.gov.
authors.forename: Joy
authors.initials: J
authors.lastname: Chang
authors.affiliation: Kenya Medical Research Institute (CDC/KEMRI), Kisumu, Kenya.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Omuomo
authors.affiliation: Kenya Medical Research Institute (CDC/KEMRI), Kisumu, Kenya.
authors.forename: Emily
authors.initials: E
authors.lastname: Anyango
authors.affiliation: Kenya Medical Research Institute (CDC/KEMRI), Kisumu, Kenya.
authors.forename: Leonard
authors.initials: L
authors.lastname: Kingwara
authors.affiliation: Centers for Disease Control and Prevention (CDC), Kenya.
authors.forename: Frank
authors.initials: F
authors.lastname: Basiye
authors.affiliation: Kenya Medical Research Institute (CDC/KEMRI), Kisumu, Kenya.
authors.forename: Alex
authors.initials: A
authors.lastname: Morwabe
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
authors.forename: Vedapuri
authors.initials: V
authors.lastname: Shanmugam
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
authors.forename: Shon
authors.initials: S
authors.lastname: Nguyen
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sabatier
authors.affiliation: Kenya Medical Research Institute (CDC/KEMRI), Kisumu, Kenya.
authors.forename: Clement
authors.initials: C
authors.lastname: Zeh
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.
authors.forename: Dennis
authors.initials: D
authors.lastname: Ellenberger
mesh_terms: D057205:Automation, Laboratory; D001769:Blood / Q000821:virology*; D003890:Desiccation; D042241:Early Diagnosis; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007630:Kenya; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Dried blood spots; Early infant diagnosis; HIV
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