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Int J STD AIDS ; 22(6): 310-4, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21680665

ABSTRACT

We evaluated the accuracy of heat-denatured, amplification-boosted ultrasensitive p24 assay (Up24) compared with reverse transcriptase polymerase chain reaction (RT-PCR). We tested 394 samples from Ugandans infected with HIV-1 non-B subtypes. We compared Up24 levels (HIV-1 p24 Core Profile enzyme-linked immunosorbent assay (ELISA), NEN Life Science Products) to RNA viral loads (Amplicor HIV-1 Monitor 1.5, Roche) by linear regression, and calculated sensitivity, specificity, positive and negative predictive values. Median viral load was 4.9 log10 copies/mL (interquartile range [IQR], 2.6-5.5); 114 samples (29%) were undetectable (<400 copies/mL). Sensitivity of the Up24 assay to detect viral load ≥400 copies/mL was 69%, specificity was 67%, and positive and negative predictive values were 84% and 47%, respectively. Sensitivity of Up24 was 90%, 80%, 68%, 62% and 45% to detect viral loads of >500,000, 250,000-500,000, 100,000-250,000, 50,000-100,000 and 400-50,000 copies/mL, respectively. In conclusion, when compared with RT-PCR for patients infected with non-B subtypes, the Up24 demonstrated limited sensitivity especially at low viral loads. Moreover, the Up24 was positive in 33% of samples deemed undetectable by RT-PCR, which may limit the use of the Up24 to detect viral suppression.


Subject(s)
HIV Core Protein p24/analysis , HIV Infections/diagnosis , Adult , Developing Countries , Enzyme-Linked Immunosorbent Assay/methods , HIV Infections/blood , HIV Infections/immunology , HIV-1/isolation & purification , Humans , Linear Models , Protein Denaturation , Reverse Transcriptase Polymerase Chain Reaction/methods , Sensitivity and Specificity , Uganda , Viral Load/economics , Viral Load/methods
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