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The effectiveness of the coronavirus test kit is under questioning. /VCG Photo
The effectiveness of the coronavirus test kit is under questioning after a confirmed patient failed to test the novel virus three times, Beijing News reported.
Before the patient who flew from Wuhan to Beijing was diagnosed with the 2019-nCoV in China-Japan Friendship Hospital on Friday, his oropharyngeal swabs had only been tested positive for the 2009 H1N1 virus.
So he was at first treated as a severe 2009 H1N1 virus patient when admitted to the hospital on January 30. Only after the Bronchoalveolar lavage, a lower respiratory tract test in which a bronchoscope is passed through the mouth or nose into the lungs to collect the samples did the doctors spot the coronavirus virus.
An anonymous respiratory physician in Beijing told Beijing News a routine checkup to a suspect case requires two oropharyngeal swabs tests. As long as there is one positive result, then the case can be confirmed by doctors. But if both results are negative, the patient is likely to be ruled out.
The patient's oropharyngeal swabs tests for 2019-nCoV suggested were negative for three times.
"Lesions occur in the lungs, that is, the lower respiratory tract, sometimes just testing the oropharyngeal swabs in the upper respiratory tract cannot help find the pathogen," Ding Xinmin, chief physician of respiratory department at Beijing Shijitan Hospital explained.
"That's why the patient was confirmed after the Bronchoalveolar lavage test," he added, "However, it is difficult to collect testing samples from the lower respiratory tract for every suspected patient in the current situation, which also poses a challenge to the diagnosis."
He also said that it is not a typical case, people don't have to be panic, but for the patients who have been cured and discharged from hospitals, follow-up checkups and close observation should be kept up.
A physician looks at a patient's CT scan. /VCG Photo
Diagnostic test kit in China
The nucleic acid test kit is an essential diagnostic tool to combat against the novel coronavirus pneumonia. According to Xinhua, more than 43,000 samples had been tested in Wuhan, the epicenter of the pneumonia outbreak.
As the confirmed cases spiral, the demand for the test kit is also growing. China's National Medical Products Administration (NMPA) has granted medical device registration certificates to seven companies who have produced the diagnostic test kit within just seven days.
On Sunday's press conference held by the National Health Commission, CCTV reporter raised questions to NMPA's staff responsible for company's qualifications about the effectiveness and safety of the batch of test kits.
Jiang Deyuan, the specialist of the medical device inspection department at NMPA, said the products had been proved effective in the clinical trials, the reason they can have quick approval is that they are in the emergency approval list.
On January 22, NMPA organized a group of experts from China's Center for Disease Control and the best clinic physicians to evaluate and review the effectiveness of the nucleic acid test kits for the new coronavirus, in a move to speed up the products' application process.
"Products quality and safety are well guaranteed. We set strict application standards for the test kits at both provincial and national level," Jiang stressed.
