Unauthorized saliva testing kits

Ho Chi Minh CityThere are many commercially available saliva rapid test kits on the market, many of which have not been licensed by the Ministry of Health.

Ms. Thuy Trang (29 years old, Bien Hoa Dong Nai) said that after an hour of searching on websites, she chose to buy a saliva test kit introduced from Germany for 600,000 VND/box of 5 pieces.

“I’m very scared when taking nasal swabs, every time I go to the ward to take samples for screening, it’s very stressful. Recently, unfortunately, my family has F0, I have no symptoms but have to be tested continuously, so I need to buy a kit. saliva test”, Ms. Trang said the reason. The seller instructed Ms. Trang how to use “just get up early in the morning, don’t rinse your mouth, don’t eat or drink, the results will be more accurate”.

Ms. Nguyen Thi Hien (37 years old, Thu Duc City) has also bought a set of 5 saliva test kits for family use. Among the saliva test kits with many designs, Ms. Hien bought from a person living in the same apartment and sold for 95,000 VND/kit, she bought 5 kits for 90,000/kit. She said that the reason for buying the saliva kit was that the family had children and the elderly, and at the same time, she herself was afraid when taking nasal secretions, “painful tears”.

According to Ms. Hien, buying a saliva test kit is very easy, just send an online message to order, about 15 minutes after the seller delivers, pays, and has a video tutorial on how to use it.

“The sellers all claim that their kits are quality products, genuine imported. The price is different for each place, but they can’t provide licenses or documents to prove origin from Germany, the US as they say. I chose to buy a kit from a Chinese company that was licensed by the Ministry of Health at the end of October,” said Hien. After using, Ms. Hien introduced her neighbors to buy this kit.

Vendors recommend saliva test kits

On online sales sites, saliva test kits are sold for many prices from 60,000 to several hundred thousand dong. For example, a test kit originating from China is offered for retail sale at 60,000-105,000 VND/kit, buying a whole box of 20 kits costs 62,000-75,000 VND/kit, cheaper than the test kit price.

Another brand’s saliva test kit, introduced by the seller as imported from Germany, has 5 kits in each box, for sale from VND 450,000 to VND 600,000. A type is also advertised from Germany, priced at 140,000-150,000 VND/kit. One type is introduced by the seller from the US, priced at 600,000 VND to 650,000 VND/box of 5 pieces. The seller cannot prove the provenance and license of these biologicals, but advertises the product as “over 98% accuracy, no cross-reactivity, no pain, no discomfort”.

A saliva test kit. Photo: Characters provided

Answer VnExpress, a woman selling the kit said: “For the group of people who are afraid of taking nasal secretions, the saliva kit is very suitable. Many people think that the saliva test kit is easy to sample, in fact not following the instructions correctly leads to easy results. The results are wrong, so I give instructions very carefully to the customer”. This person, like many other kit sellers, said “the product is selling well” but did not disclose sales.

Meanwhile, the health authorities are quite Use caution when approving salivary test kits versus nasopharyngeal test kits. In 2020, the US Food and Drug Administration (FDA) is providing emergency use and authorization for a test kit that uses saliva (generally) to diagnose Covid-19 in laboratories. However, it was not until June 2021 that the FDA gave emergency approval to the Diabetomics saliva test kit for use at health care facilities for adults and children in the United States.

At the end of 2020, the Health Sciences Authority of Singapore for the first time approved the nCoV test kit using a saliva sample, called Resolute 2.0 from Advanced MedTech Holdings. This method is said to be less invasive because the tester only needs to discharge saliva into a sample vial.

Japan has been using Shinogi’s saliva test kit since August 2020. Currently, biological products are used by this country for rapid inspection for passengers entering from seaports and airports because the processing time only takes about 25-30 minutes/sample and can make many samples at the same time. Positive results for nCoV will be further checked by PCR molecular biology test.

Similarly, in Vietnam as of August 2021, the Ministry of Health has approved 16 types of rapid test for nCoV antigen using nasal and nasopharyngeal secretions; until October Only one type of saliva test kit has been licensed is Antigen Rapid W-AgS04-B20 manufactured by Wuhan (China) company. However, currently, most hospitals, medical centers, and testing points nationwide still use test kits for nasopharyngeal disease. Doctors believe that the accuracy of test results depends greatly on the behavior of the person being sampled, so medical facilities do not use saliva kits.

Dang Van Thanh (General Director of Saigon South General Hospital) explained the reason why the hospital has not implemented a rapid saliva test: “It is required that the person receiving the saliva sample must not drink or eat at least one hours before taking samples for testing. Therefore, just being careless, drinking water or eating before taking foam samples will easily lead to erroneous test results.”

According to Dr. Truong Huu Khanh (Advisor of Department of Neurological Infections, Children’s Hospital 1, Vice President of Ho Chi Minh City Infectious Association), the saliva test kit can detect Covid-19 antigens through saliva samples taken from back of the throat. The test mechanism is similar to the test kit for fluid collected from the oropharynx (through the nose and oropharynx) being used today.

Before taking a saliva sample for testing, the person being sampled should not drink or eat for at least an hour, relax the cheek area and gently rub it for 15-30 seconds with the finger. Then, the collected saliva sample is mixed with the solution provided by the manufacturer and put in the test tray, giving results after 15 minutes – this method is similar to the nasopharyngeal test kit. Thus, the difference between a saliva test kit and a nasopharyngeal test kit is the sampling location and secretions; In addition, taking saliva does not give the same uncomfortable feeling as when taking fluid in the nose.

Doctor Khanh also acknowledges the fact that many people are afraid of “picking their nose”., especially for children, should buy a saliva test kit. “According to research, the salivary gland located under the tongue, from the back of the throat, contains a high viral load, so testing for Covid-19 with a saliva kit still gives the same effectiveness as the fluid taken from the oropharynx. However, it is necessary to choose choose reputable test kits, have clear origin, strictly follow the instructions when using,” said Dr. Khanh.

Answer VnExpress On December 15, Mr. Nguyen Tu Hieu (Deputy Director of Medical Equipment and Construction Department, Ministry of Health) said: “Through the quality inspection process, currently the Ministry of Health has only approved one type of test kit. saliva put into circulation in the market”. He advised people “should select the test kits included in the approval list Ministry of Health to ensure quality”

Doctor Hung evaluates the accuracy of two test kits

According to Dr. Le Quoc Hung (Head of Department of Tropical Diseases, Cho Ray Hospital), each test method has different meaningful goals. PCR tests are affirmative, diagnostic and 100% accurate, while rapid test kits have lower accuracy and are Covid screening properties. According to Dr. Hung with many years of experience working in the infectious disease specialty, the test results for nasopharyngeal disease have an accuracy of 85%, while the test results through Salivary fluid accuracy about 65-70%.

Director of the HCM City Department of Health Tang Chi Thuong said: “The test kit uses samples of saliva or nasal secretions, the results are almost the same. It is important to choose a quality test kit that has quality assurance. clear origin approved by the Ministry of Health”.

People who are sensitive to nasal discharge, are allergic to nosebleeds, children who have difficulty getting nasal secretions, etc., can use a saliva test kit for screening purposes before going to the office. medical. “However, regardless of the test method, it is necessary to carefully learn about the sensitivity and accuracy of the kit under the license of the medical regulatory authority to reduce the rate of negative and false positives,” said Dr. Dr. Hung recommended.

Deputy Director of Ho Chi Minh City Department of Health Nguyen Hoai Nam, in a press conference in mid-July, also advised people Don’t buy test kits fast for sale online but not listed in the license list. Accordingly, many types of rapid tests sold on the market have low sensitivity and inaccurate results. People who test negative results will lose vigilance, go to many places, come into contact with many people, when in fact that result may be positive, the risk of spreading and spreading the disease to the community.

Testing has always been one of the pillars in the strategy to fight the epidemic and adapt to Covid-19, opening borders in many countries. In Vietnam, in the context of a high and rapid increase in the number of infections, the Ministry of Health allowed F0 to be treated at home, encouraging people to take samples for quick test at home, even in some localities such as Ho Chi Minh City and Hanoi. can use rapid test results to determine F0 and quickly take appropriate preventive measures to prevent community infection.

Le Cam


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