Method verification study for nucleic acid test system
  
View Full Text  View/Add Comment  Download reader
DOI:
KeyWord:nucleic acid, verification, lowest limit of detection, specificity, accuracy, anti-interference
                    
AuthorInstitution
Libo Zhang Nanjing Red Cross Blood Center, Nanjing 210003, Jiangsu, China
Chengping Ma Nanjing Red Cross Blood Center, Nanjing 210003, Jiangsu, China
Rongrong Pang Nanjing Red Cross Blood Center, Nanjing 210003, Jiangsu, China
Yuan Ke Nanjing Red Cross Blood Center, Nanjing 210003, Jiangsu, China
Min Huang Nanjing Red Cross Blood Center, Nanjing 210003, Jiangsu, China
Wenping Han Nanjing Red Cross Blood Center, Nanjing 210003, Jiangsu, China
Xiaojun Lu Nanjing Red Cross Blood Center, Nanjing 210003, Jiangsu, China
Hits: 138
Download times: 375
Abstract:
      To identify a suitable method for nucleic acid test(NAT) system verification, several methods were used to verify the system's key parameters, such as the lowest limit of detection, specificity, accuracy and anti-interference ability. The lowest limit of detection for Grifols' Procleix Tigris System were HBV DNA 3.1 U/mL, HCV RNA 5.0 U/mL, HIV RNA 21.2 U/mL; accuracy 100%; anti-interference lipemia (triglyceride)< 33.23 mmol/L, hemolysis (hemoglobin concentration)<5 g/L. There were no significant differences between the claimed specification of both the Grifols' Procleix Tigris Systems and reagents, which both met with published test requirements. New equipment installation or regular verification are necessary to ensure the reliable operation of equipment, which ensure the quality of analysis and test. A systematic method was practiced in our laboratory, which was able to confirm that commercial NAT reagents meet the rigorous standards of blood screening. This study provides a very useful model for other blood screening laboratories and NAT kits.
Close