![]() The samples (VTM) were opened in biosafety cabinet class‐II and 300 μl of the VTM was further processed for viral nucleic acid extraction by a chemagic Viral DNA/RNA Kit on a chemagic™ 360 instrument (Perkin Elmar) as per the manufacturer's protocol. Performance of RT‐PCR on direct unpooled clinical specimens Thus, this study was planned to compare and evaluate seven commercially available COVID‐19 RT‐PCR kits for pooled samples' testing (Table (Table1 1).Ģ.3. 10 Several countries are performing pooled sample testing for COVID‐19, however, none of the available RT‐PCR kits has been tested for pooled sample either by kit manufacturer or research groups. 8, 9 In a recent study from the University of Nebraska Medical Centre, Omaha, the authors have used a web‐based application and determined the most efficient pool size to be five samples when the incidence rate of SARS‐CoV‐2 infection is 10% or less and concluded that group testing will result in saving of reagents and increase in the testing capability of at least 69%. ![]() Several researchers are advocating that it is time to reintroduce the Dorfman theory 7 of sample pooling in the era of molecular testing. However, at the same time, the disease is new it is important to validate modifications to the testing protocol before universal adoption. It has become important to come up with novel ideas to conserve the reagents used for molecular tests. Many countries are experiencing acute shortages of diagnostic kits and manufacturers of molecular testing kits and consumables are also struggling to keep with the demand. 6 RT‐PCR is an expensive test and requires a well equipped molecular laboratory with trained manpower. There are more than 350 Conventional RT‐PCR COVID‐19 testing kits available commercially, of which 29 kits have been approved by the United States food and drug administration (US‐FDA). Amongst them, conventional RT‐PCR is the preferred and most widely used test for COVID‐19 diagnosis. The test available for laboratory diagnosis of COVID‐19 includes point of care antigen detection, Conventional real‐time polymerase chain reaction (RT‐PCR), cartridge‐based test molecular test like GeneXpert (Cepheid) and Truenat (Molbio), and automated high throughput molecular assays like Roche Cobas, Abbot molecular SARS CoV‐2 assay, Glenmark ePlex assay, and so forth. 1 World Health Organization (WHO) declared a pandemic on Ma2 and urged that the most effective way to prevent infections and save lives is breaking the chains of transmission, and to do that escalation of COVID‐19 testing is urgently required. The on‐going coronavirus disease‐2019 (COVID‐19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) started in December 2019 from Wuhan, China. However, regarding performing pooled sample testing, it might be advisable to use those kits that performed best regarding positive identification in samples' pool, that is TRUPCR SARS‐CoV‐2 Kit, TaqPath RT‐PCR COVID‐19 Kit, Allplex 2019‐nCOV Assay, and BGI Real‐time RT‐PCR kit for detecting SARS CoV‐2. ![]() We conclude that all seven commercially available RT‐PCR kits included in this study can be used for routine molecular diagnosis of COVID‐19. ![]() However, the Fosun kit, LabGun Kit, and Patho detect kit could detect only 90%, 85%, and 75% of weakly positive samples, respectively. All seven kits detected all sample pools with low C t values (30) the TRUPCR Kit, TaqPath Kit, Allplex Assay, and BGI RT‐PCR kit showed 100% sensitivity, specificity, and accuracy. Diagnostic accuracy of (1) TRUPCR SARS‐CoV‐2 Kit (Black Bio), (2) TaqPath RT‐PCR COVID‐19 Kit (Thermo Fisher Scientific), (3) Allplex 2019‐nCOV Assay (Seegene), (4) Patho detect COVID‐19 PCR kit (My Lab), (5) LabGun COVID‐19 RT‐PCR Kit (Lab Genomics, Korea), (6) Fosun COVID‐19 RT‐PCR detection kit (Fosun Ltd.), (7) Real‐time Fluorescent RT‐PCR kit for SARS CoV‐2 (BGI) was evaluated on precharacterised 40 positive and 10 negative COVID‐19 sample pools. Thus, this study was planned to compare and evaluate seven commercially available kits for pooled samples testing. There are more than 350 real‐time polymerase chain reaction (RT‐PCR) coronavirus disease‐2019 (COVID‐19) testing kits commercially available but these kits have not been evaluated for pooled sample testing. ![]()
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