Point-of-care medical diagnostic products evaluated with the scorecard.

<p>Point-of-care medical diagnostic products evaluated with the scorecard.</p

Diagnostic technology scorecard assessment criteria with scoring thresholds and weightings.

<p>Diagnostic technology scorecard assessment criteria with scoring thresholds and weightings.</p

Spider-plot scores of the highest performing technologies.

<p>Spider-plot scores of the highest performing technologies.</p

Score, rank and inter-class correlation of point-of-care technologies assessed with the scorecard.

*<p>all p-values<0.0001.</p

Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity

<div><p>The long delay in returning test results during early infant diagnosis of HIV (EID) often causes loss-to-follow-up prior to antiretroviral treatment (ART) initiation in resource-limited settings. A point-of-care (POC) test may help overcome these challenges. We evaluated the performance of the LYNX p24 Antigen POC test in Mozambique. 879 HIV-exposed infants under 18 months of age were enrolled consecutively at three primary healthcare clinics (PHC). Lancet heel-drawn blood was tested on-site by nurses using a prototype POC test for HIV Gag p24 antigen detection. Results of POC testing were compared to laboratory-based nucleic acid testing on dried blood spots. A comparison of the effect of sensitivity and timely test results return on successful diagnosis by POC and laboratory-based platforms was also calculated. The sensitivity and specificity of the LYNX p24 Ag test were 71.9%; (95% confidence interval [CI]: 58.5–83.0%) and 99.6% (95% CI: 98.9–99.9%), respectively. The predictive value of positive and negative tests were 93.2% (95% CI: 81.3–98.6%) and 97.9% (95% CI: 96.8–98.8%), respectively. Overall agreement was high (Cohen Kappa = 0.80; 95% CI: 0.71–0.89). Despite its lower sensitivity, the POC test had the potential to provide test results to up to 81% more patients compared to the laboratory-based test. This prototype POC p24 assay was feasible for use in PHCs but demonstrated low sensitivity for HIV detection. POC EID technologies that perform below standard recommendations may still be valuable diagnostic tools in settings with inefficient EID networks.</p></div

Demographic and Clinical Characteristics of Mother—Infant Pair Study Participants.

<p>Demographic and Clinical Characteristics of Mother—Infant Pair Study Participants.</p

Comparing Technologies for Potential Patient Identification.

<p>Comparing Technologies for Potential Patient Identification.</p

Flow diagram of study participants.

<p>Flow diagram of study participants.</p

Performance of the Lynx POC EID p24 Ag test by health care facility and operator.

<p>Performance of the Lynx POC EID p24 Ag test by health care facility and operator.</p