Performance of an alternative laboratory-based algorithm for HIV diagnosis in a high-risk population

Evaluation of the CDC proposed laboratory HIV testing algorithm among men who have sex with men (MSM) from five US metropolitan statistical areas using specimens collected in 2011

“…This study demonstrated that the proposed laboratory-based algorithm performs well in high-risk populations and the incorporation of NAAT improved the detection of acute infections. These data add to several previous studies [6,[20][21][22] to further support the use of the CDC proposed algorithm. The results also substantiate previous findings regarding reduced sensitivity of OF testing during acute infection and in the presence ARVs [28][29][30][31][32][33] and highlight the importance of selecting the right sample type and diagnostic tests when choosing testing strategies in populations with high rates of acute infection and potential confounding effects of ARVs.…”

“…In addition, the sensitivity and specificity of the algorithm in established infections has been shown to be higher than 99% [6]. Initial screening with 3rd generation IA in the context of the proposed algorithm also showed high sensitivity and specificity in persons with established infections, blood donors, high-risk populations, and has allowed correct classification of specimens [21,22]. The current study was initiated to obtain additional performance data for the CDC proposed algorithm in high risk individuals.…”

Delaney et al. respond to Dr. Apfelroth

“…None of the 4 false-positive specimens about which Dr. Apelfroth inquired, nor any of the 8 other singly reactive false-positive specimens, were reactive on any of the immunoassays in the current study. 2 Because the Vironostika assay is no longer commercially available, we focused our evaluation of the alternative algorithm on the contemporary IgM-sensitive immunoassays. Consistent with Dr. Apfelroth's concern, we paid particular attention to the ability of the algorithm to correctly classify specimens that were false positive on one or more of these immunoassays.…”

Use of the Abbott Architect HIV antigen/antibody assay in a low incidence population

“…If the specimen is negative or indeterminate for HIV-1 and HIV-2 antibodies on the second or supplemental test it is then tested for HIV-1 RNA. In using this algorithm, there are very few specimens which will require HIV-1 RNA testing [7]. The algorithm is structured to have a high predictive value for positive results with the minimum number of tests.…”

“…The 4th generation testing is beneficial in all incidence settings. The performance of the algorithm in a high incidence population has been studied [7].…”