Saliva testing is a technology that detects the corona 19 virus gene in the saliva when a tester spits it into a plastic container to determine whether it is infected. Seegene offer
Seegene, a molecular diagnostic company, has been approved for a test method to diagnose novel coronavirus infections (COVID-19, Corona 19) with saliva (saliva) in Europe. The saliva test method is simple to collect a sample, and unlike the existing sample collection method, it does not require a medical staff to collect, so the test speed can be increased.
Seegene announced on the 7th that it has recently obtained permission to change the European In Vitro Diagnostic Reagent Certification (CE-IVD) for applying the saliva test method to two types of Corona 19 Gene Amplification (PCR) diagnostic kits. This means that it is permitted to diagnose with acupuncture in addition to the conventional method of obtaining a sample to be used in the diagnostic kit with a cotton swab deep in the nose. The diagnostic kits that have been approved for modification are the All-Flex kit that diagnoses four types of Corona 19 genes, and a kit that simultaneously diagnoses Corona 19, flu, and cold.
In the saliva test method, when an examiner spits on a plastic tube, the corona 19 test is performed with that saliva. As the Corona 19 virus multiplies throughout the respiratory tract, such as the nose, mouth, and throat, the virus is used not only in the nose, throat, but also in saliva. After collecting the sample, the diagnosis follows the method used by other PCR diagnosis methods.
Andrew Brooks, a research team at Rutgers University’s genetics department, received emergency use approval (EUA) from the US Food and Drug Administration (FDA) in April last year. As a result of conducting a clinical trial on 60 patients, it was found that the accuracy was 100% consistent with the existing specimen collection method. Seegene also announced in September of last year that when the Seegene diagnostic kit was used as a saliva test, it obtained the same accuracy as the conventional specimen collection method as a result of an analysis of the Washington Children’s National Hospital.
Saliva testing can reduce medical overload by eliminating the need for a medical staff to collect samples. The nasopharyngeal smear, which is currently mainly used, requires a medical staff to collect a sample by scraping the mucous membrane located deep in the nose with a cotton swab. The saliva test method only needs to be submitted by spitting, so anyone can collect a sample.
The saliva test method also has the advantage of not requiring separate facilities and quarantine measures. The nasopharyngeal smear also poses a risk of infection for the examiner as the patient being tested may sneeze during the examination. Therefore, the medical staff collects the specimen in a separate space and discards all medical tools such as protective clothing, gloves, and masks used during the collection process. There is no direct contact with the saliva test method, saving the cost of this process.
The background of Europe’s approval of the saliva test method is that the test volume is rapidly increasing due to the recent Corona 19 relapse in Europe. Korea also introduced a saliva test method for diagnosis on the 7th of last month as the number of corona19 patients increased due to the third epidemic. You can choose a nasopharyngeal smear or saliva test at a temporary screening laboratory to be diagnosed.
An official from Seegen said, “I hope that the approval of the application of the saliva test method for this Corona 19 product will help to improve the situation in Europe where the number of confirmed cases is rapidly increasing.”