[단독] Corona tests using saliva

A PCR (gene amplification) saliva diagnostic kit that can diagnose corona infection with just saliva without taking samples by stabbing deep into the nose has been approved by the Ministry of Food and Drug Safety for the first time in Korea. AMS Bio, a subsidiary of the Biosmart Group with a pharmaceutical biobusiness unit and developer of in vitro diagnostic devices and diagnostic reagents, said, “A + CheQ, a corona saliva PCR kit developed by the company, was approved by the Ministry of Food and Drug Safety on the 3rd We have officially received item approval,” he said on the 9th. Before Aplus CheckQ, the PCR saliva diagnostic kit was officially recognized for safety and effectiveness by a national organization last year, Thermo Fisher Scientific’s ‘TaqPath Combo Kit’ approved by the US Food and Drug Administration (FDA 2.0) is known.

The Aplus CheckQ saliva test corona diagnostic kit was approved by AMS Bio in June 2021 by adding a saliva sample method to the PCR diagnostic kit product which is deeply stabbed in the nose (nasopharyngeal swab). To collect a corona sample by inserting a cotton swab into the nose, skilled medical personnel such as nurses, doctors and clinical pathologists are needed, but in the saliva test, the sample is collected by simply spitting into the container. It’s less psychologically taxing than getting stabbed in the nose. If you spit out the reagent and run the extractor, the result comes out in about an hour.

Since the onset of COVID-19 in early 2020, many bio companies have been working on developing saliva test diagnostic kits, but quarantine authorities have made it a rule to test nasopharyngeal swabs. Oral samples were only allowed in exceptional cases where it was medically impossible to collect samples from inside the nose. At the end of 2020, during the third corona epidemic, the government only introduced saliva tests in temporary screening centres. However, it was noted that the saliva test was relatively less accurate than the conventional method of sticking a cotton swab in the nose, even for the same gene amplification test. At that time, the sensitivity (the ability to positively identify an infected person) was more than 98% for the swab collection method by sticking the inside of the nose, but only 92% for the saliva test method.

In fact, the key to saliva testing is to prevent contamination that can occur when foreign substances such as food, drugs, or mouthwash are mixed with saliva. This is because the higher the contamination, the lower the accuracy. An official from AMS Bio said, “We performed all 50 tests specified in the US FDA saliva test guide in accordance with the requirements of the Food and Drug Safety Administration, but there was no interference.” As with the horse test, the saliva test the sensitivity and specificity of a diagnostic kit (the ability to discriminate an uninfected person as negative) is 100% each.”

AMS Bio said, “After receiving a corona diagnosis test where a cotton swab is placed in a child’s nose, there were many complaints that the mask was wet due to a nosebleed. It can be conveniently used to collect influenza (flu) or RSV (respiratory syncytial virus) Samples, so it will be particularly useful for hospitalized patients and young patients.” At present, it is known that three or four domestic diagnostic kit manufacturers are conducting clinical trials or conducting experiments to increase the accuracy of saliva PCR in order to obtain official item approval from the Ministry of Food and Drug Safety.