Validation of Dried Tube Sample Format Quality Controls for the Monitoring of Viral Load and Blood Screening Assays.
J Virol Methods
; 285: 113957, 2020 11.
Article
em En
| MEDLINE
| ID: mdl-32805272
ABSTRACT
HIV viral load (VL) and donor screening assays experience variation and require quaity assurance (QA). NRL sought to confirm a dried tube sample format (HIVDTS) sample type for use in quality control (QC) programs for HIV molecular testing. 50 µL of HIV supernatant at 1 × 105 copies per millilitre (copies/mL)) was dried for 48 hours at room temperature. Post-production and shipped integrity studies were undertaken. Dried HIVDTS was reconstituted in PBS buffer and tested in HIV VL (six participants) or blood screening assays (four participants). Results were entered into NRL's QC monitoring software (EDCNet™) for analysis. The mean of 224â¯VL results when HIVDTS QCs were tested in Biocentric HIV GENERIC Charge Virale assay was 4.54 log10 copies/mL, with the percentage coefficient of variation (CV%) ranging from 1.75 to 13.20%. The mean Ct value for HIVDTS QCs tested on Roche Cobas MPX assay results was 28.71 (range 28.33 to 29.14), with CV% ranging from 1.56 to 3.98%. The study confirms HIVDTS QCs can effectively monitor the performance of HIV molecular testing and offers a cheaper alternative to commercial QC samples that require cold-chain shipping on dry ice and UN3373 conditions.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Controle de Qualidade
/
Infecções por HIV
/
HIV-1
/
Carga Viral
/
Teste em Amostras de Sangue Seco
Tipo de estudo:
Diagnostic_studies
/
Screening_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article