20 COVID-19 testing kits approved by China

As of March 23, a total of 20 of nucleic acid and antibody testing kits for COVID-19 have gained approval for clinical use, according to National Medical Products Administration. National Medical Products Administration is the authority in China to supervise the safety and regulate the registration of drugs, medical devices and cosmetics.

At present, the nucleic acid testing kit and antibody testing kit are the two main types of detection kits approved by China's National Medical Products Administration for clinical us.

Nucleic acid testing currently remains the primary detection method for the novel coronavirus in China. The average detection time for the nucleic acid testing takes two to three hours with strong specificity and relatively high sensitivity.  

An antibody testing method can screen patients within 15 minutes. However, antibody testing cannot replace nucleic acid testing, because the antibody testing can provide an auxiliary diagnosis for those negative cases detected by nucleic acid testing.

More detection kits and methods are on their way to be put into use as China continues to make progress in developing detection kits and gaining more knowledge of the novel coronavirus, according to China's National Medical Products Administration.

The following is the latest list of testing kits for COVID-19 approved by China's National Medical Products Administration. Please click here for the list.



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