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Specificity of 2019-nCoV nucleic acid detection kit (fluorescence PCR)
Chinese Journal of Biologicals ; 34(5):560-565, 2021.
Article in Chinese | EMBASE | ID: covidwho-1857139
ABSTRACT
Objective To evaluate the specificity of three consecutive batches of 2019-nCoV nucleic acid detection kit (fluorescence PCR) manufactured by Shanghai GeneoDx Biotech Co., LTD. Methods A total of 55 common respiratory pathogens, including endemic human coronaviruses (HKU1, OC43, NL63 and 229E), severe acute respiratory syndrome conronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS), seasonal influenza virus, rhinovirus, adenovirus, Klebsiella pneumonia and Mycobacterium tuberculosis, were grouped and used for verification of cross reactivity of the detection kit. According to the requirements in the Key Points of Technical Review for Registration of 2019 New Coronavirus Nucleic Acid Detection Reagents issued by Center for Medical Device Evaluation, National Medical Products Administration (NMPA), human mucoprotein, human blood, phenylephrine, oxymetazoline, sodium chloride (including those as preservatives) and other 29 interfering substances were selected to verify the anti-interference substances of this kit. Results In the verification for cross reactivity, the test results of mixed positive samples by the three consecutive batches of kit were positive, while those of negative samples were negative, indicating a coincidence rate of accuracy of 100%. The cross-reactive substances showed no effect on the test result by the kit. All the test results of positive and borderline positive samples were positive, while those of negative samples were negative, indicating a coincidence rate of accuracy of 100%. All the 29 kinds of endogenous / exogenous interfering substances showed no influence on the test results by this kit. Conclusion Hie new coronavirus 2019-nCoV nucleic acid detection kit (fluo¬rescence PCR method) manufactured by Shanghai GeneoDx Biotech Co., LTD. showed no cross-reactivity with 55 common respiratory pathogens, while showed anti-interference properties against endogenous and exogenous interfering substances such as host tissue, common respiratory pathogen and common drugs for respiratory diseases in clinic. The specificity test result of the kit met the requirements for registration of 2019 new coronavirus nucleic acid detection reagents. The test results of three consecutive batches of kits were highly stable.
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Collection: Databases of international organizations Database: EMBASE Type of study: Diagnostic study Language: Chinese Journal: Chinese Journal of Biologicals Year: 2021 Document Type: Article

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Collection: Databases of international organizations Database: EMBASE Type of study: Diagnostic study Language: Chinese Journal: Chinese Journal of Biologicals Year: 2021 Document Type: Article