Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0.
J Clin Lab Anal
; 34(7): e23280, 2020 Jul.
Article
in En
| MEDLINE
| ID: mdl-32167624
ABSTRACT
BACKGROUND:
The Daan HCV RNA quantitative assay was a recently developed kit with high sensitivity for the detection of HCV RNA. We aimed to evaluate the analytical performance of the Daan HCV RNA quantitative assay and compare it with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0.METHOD:
WHO HCV RNA standard, NIBSC 06/102 standard, and CLSI EP documents were used to evaluate the precision, accuracy, linearity, anti-interference ability, and cross-reactivity of the Daan HCV RNA quantitative assay. Overall 198 clinical serum specimens were used to make comparison between the Daan HCV RNA quantitative assay and the Roche Cobas test.RESULTS:
The within-run precision (Swithin ), and total precision (Stotal ) for 6.11 log IU/mL, 4.22 log IU/mL, and 2.32 log IU/mL HCV RNA were 0.13 and 0.15, 0.07 and 0.09, and 0.11 and 0.10, respectively. The linear range was 20-108 IU/mL, and the limit of detection was 15 IU/mL. It did not display any interference with commonly encountered conditions and cross-reactivity with some common virus. A good agreement was observed between the Daan HCV RNA quantitative assay and the Roche Cobas test.CONCLUSION:
The Daan HCV RNA quantitative assay has shown satisfactory performances and excellent agreement with COBAS HCV Quantitative Test on clinical specimens with lower cost, which provides an alternative choice for the diagnosis and monitoring of HCV infection in developing countries.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Reagent Kits, Diagnostic
/
RNA, Viral
/
Hepatitis C
/
Real-Time Polymerase Chain Reaction
Type of study:
Evaluation_studies
Limits:
Humans
Language:
En
Journal:
J Clin Lab Anal
Journal subject:
TECNICAS E PROCEDIMENTOS DE LABORATORIO
Year:
2020
Document type:
Article
Affiliation country:
China