Validation of Commercial Kits Using Standard ICMR Protocol
VirusDisease
; 34(1):112-113, 2023.
Article
in English
| EMBASE | ID: covidwho-2318268
ABSTRACT
Background:
SARS-CoV-2 highlighted worldwide, the need of enhance testing capacity. Government of India, under Atmanirbhar Bharat provided platform to private/public companies to develop and manufacture diagnostic reagents /kits for SARS CoV 2 testing. Objective(s) * Performance evaluation of commercial kits. * Handholding of private/public companies to improve the kits quality for its diagnostic accuracy to use for Covid 19 diagnosis Material(s) and Method(s) The SOP for the validation of diagnostic kits were prepared and approved by ICMR technical committee. The ICMR NIV single tube assay was used as gold slandered. The panels of known positives and negatives were prepared. Validation of commercially developed RT-PCRs, RNA extraction kits and virus transport medium were undertaken. The sensitivity and specificity of the kit were calculated and reported as per ICMR's acceptance. Result(s) Real time RT-PCR kits evaluation Total 165 kits were evaluated, which includes 12 LAMP assay. Among domestic kits, 31 kits were satisfactory while 83 were not satisfactory. Among the imported kits, 25 kits were satisfactory while 26 were not satisfactory. RNA extraction kits evaluation- Total 157 kits were evaluated, Among domestic kits, 57 kits were satisfactory while 53 were not satisfactory. Among the imported kits, 31 kits were satisfactory and 17 were not satisfactory. VTM kits evaluated = Total 89 kits were evaluated among which nine kits were imported while 80 kits were of domestic origin. Performance of 10 kits was not satisfactory. Conclusion(s) Kit validation is important to access the quality of commercial kits and to enhanced the testing capacity exponentially in country.
conference abstract; controlled study; coronavirus disease 2019; diagnosis; diagnostic accuracy; diagnostic kit; diagnostic test accuracy study; human; loop mediated isothermal amplification; nonhuman; real time reverse transcription polymerase chain reaction; RNA extraction; sensitivity and specificity; testing capacity; transport medium; validation process; virus
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Prognostic study
Language:
English
Journal:
VirusDisease
Year:
2023
Document Type:
Article
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