Multicenter clinical performance evaluation of BD Veritor™ system for rapid detection of respiratory syncytial virus.

BACKGROUND: BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a new-generation lateral flow immunochromatographic assay for objective detection of RSV in respiratory specimens from children. OBJECTIVE: To evaluate the performance of BD Veritor™ System for Rapid Detection of RSV in respiratory specimens collected from pediatric patients. STUDY DESIGN: A prospective, multicenter clinical trial was undertaken at five study sites representing geographically diverse regions of the U.S. to assess the performance of the BD Veritor™ System for Rapid Detection of RSV in comparison to R-mix shell vial culture and ProFlu+ reverse transcription-PCR assay (Gen-Probe/Prodesse). RESULTS: 440 nasopharyngeal washes/aspirates (NPW/A) and 706 nasopharyngeal swab (NPS) specimens from U.S. subjects<20 years of age were collected and tested using the BD Veritor™ System and compared with shell vial culture and real-time RT-PCR results. Analysis of the data indicates the overall sensitivity and specificity for BD Veritor™ System for all sample types combined was 90% and 97.0% versus shell vial culture and 75.5% and 98.7% versus RT-PCR respectively. CONCLUSION: Overall, the BD Veritor™ System for the Rapid Detection of RSV performed well when compared to both viral cell culture and RT-PCR in children.

Long-term highly suppressed HIV-infected children and adolescents with negative rapid HIV tests due to significant antibody loss.

BACKGROUND: Rapid HIV test devices are widely used throughout the world and are important as diagnostic tools with relatively high sensitivity and specificity. Loss of HIV specific antibodies in late-stage AIDS patients has previously been reported in patients with advanced disease (i.e., AIDS). OBJECTIVE: To study rate of antibody loss that may lead to false negative HIV-antibodies results in children and adolescents who received long term antiretroviral (ARV) treatment with persistently undetectable viral loads. STUDY DESIGN: Five FDA approved rapid HIV test kits including Trinity Uni-Gold Recombigen HIV-1, OraQuick Advance HIV-1/2, Reveal G3 HIV-1, Clearview STAT-PAK HIV-1/2, and Clearview COMPLETE HIV-1/2 were used to test 98 stored samples from 27 patients. Samples were tested at baseline and at least twice in 6-14 years post initiation of ARV treatment and full viral load suppression. RESULTS: Of the 403 tests, 43 (10.7%) were found to be false-negative using rapid HIV kits. Loss of positivity was correlated with decrease of HIV antibody titer. CONCLUSIONS: There is a slow but persistent loss of HIV specific antibodies in highly suppressed HIV infected children and adolescents that may lead to false-negative results in rapid HIV antibody tests. The temporal loss of signal is dependent on the baseline level of antibodies and the type of HIV rapid test kit used.