title: Generation of dried tube specimen for HIV-1 viral load proficiency test panels: a cost-effective alternative for external quality assessment programs.
abstract: Participation in external quality assessment programs is critical to ensure quality clinical laboratory testing. Commercially available proficiency test panels for HIV-1 virus load testing that are used commonly in external quality assessment programs remain a financial obstacle to resource-limited countries. Maintaining cold-chain transportation largely contributes to the cost of traditional liquid proficiency test panels. Therefore, we developed and evaluated a proficiency test panel using dried tube specimens that can be shipped and stored at ambient temperature. This dried tube specimens panel consisted of 20 μl aliquots of a HIV-1 stock that were added to 2 ml tubes and left uncapped for drying, as a preservation method. The stability of dried tube specimens at concentrations ranging from 10² to 10⁶·⁵ RNA copies/ml was tested at different temperatures over time, showing no viral load reduction at 37 °C and a decrease in viral load smaller than 0.5 Log₁₀ at 45 °C for up to eight weeks when compared to initial results. Eight cycles of freezing-thawing had no effect on the stability of the dried tube specimens. Comparable viral load results were observed when dried tube specimen panels were tested on Roche CAPTAQ, Abbott m2000, and Biomerieux easyMAG viral load systems. Preliminary test results of dried proficiency test panels shipped to four African countries at ambient temperature demonstrated a low inter assay variation (SD range: 0.29-0.41 Log₁₀ RNA copies/ml). These results indicated that HIV-1 proficiency test panels generated by this methodology might be an acceptable alternative for laboratories in resource-limited countries to participate in external quality assessment programs.
authors.affiliation: International Laboratory Branch, Division of Global HIV/AIDS, Center for Global Health, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA, USA.
authors.forename: Artur
authors.initials: A
authors.lastname: Ramos
authors.forename: Shon
authors.initials: S
authors.lastname: Nguyen
authors.forename: Albert
authors.initials: A
authors.lastname: Garcia
authors.forename: Shambavi
authors.initials: S
authors.lastname: Subbarao
authors.forename: John N
authors.initials: JN
authors.lastname: Nkengasong
authors.forename: Dennis
authors.initials: D
authors.lastname: Ellenberger
mesh_terms: D003890:Desiccation; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000191:economics* / Q000379:methods*; D015203:Reproducibility of Results; D013696:Temperature; D019562:Viral Load / Q000379:methods* / Q000592:standards*