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ORIGINAL ARTICLE
Year : 2020  |  Volume : 5  |  Issue : 2  |  Page : 139-145

Evaluation of a NATSpert test developed for low-resource countries for enhancing blood safety


R and D Department, Mylab Discovery Solutions Pvt. Ltd., Pune, India

Correspondence Address:
Minal Dakhave Bhosale
R and D Department, Mylab Discovery Solutions Pvt. Ltd., Pune
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/GJTM.GJTM_17_20

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Background: NATSpert ID TripleH Detection test is a qualitative multiplex real time PCR test for simultaneous screening of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type 1/2 in donated blood. Objective of the study was to evaluate NATSpert ID TripleH Detection test, developed indigenously for low resource countries for enhancing blood safety without compromising on blood safety in terms of sensitivity and specificity. Methods: The NATSpert ID TripleH Detection test consists of viral nucleic acid extraction using magnetic beads and multiplex real-time PCR based on hydrolysis probe technology for amplification and detection of the viral target. Quality controls are included for validity of the test. The performance of the test was evaluated for analytical sensitivity and specificity and precision using the World Health Organization international standards. Results: Analytical sensitivity of NATSpert ID TripleH Detection test is 2 IU/ml for HBV, 7 IU/ml for HCV, human immunodeficiency virus-1(HIV-1) M – 17.5 IU/ml, HIV-1O – 18.5 copies/ml, and HIV-2 8.17IU/ml using 1 ml sample input at 95% CI. The NATSpert ID TripleH Detection test detected all three viruses and their genotypes with high repeatability and reproducibility in validation studies. Conclusion: The NATSpert ID TripleH Detection test developed as a cost-effective solution was demonstrated to have the capability to identify either individually or simultaneously the presence of viral targets – HBV, HCV, and HIV in the donated blood. The NATSpert ID Triple H Detection test serves as a highly sensitive, specific, and accurate test for screening of donated blood for transfusion-transmitted viral infections.


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