HONG KONG – Diagnostic kits are in the spotlight as Vietnam battles a resurgence of COVID-19 cases, after a wave of community infections started appearing in late July.

A new outbreak has infected more than 220 people since July 25, most of whom came from the coastal city of Da Nang. The infections have since spread to at least eight other cities and provinces in the Southeast Asian country, including Hanoi and Ho Chi Minh City.

Of the over 88,000 people that have returned to Hanoi from Da Nang since July 8, only 70,689 have been tested, according the Vietnamese Health Ministry. Only two of those were found positive.

A shortage of rapid testing kits, which are used to screen thousands of residents at a time, was the reason for the gap, according to state media reports.

The Vietnamese Ministry of Health has stated that it would assist medical institutions and hospitals in Hanoi to give the testing capacity a boost.

However, not all agree that supplies are to blame.

Phan Quoc Viet, the chairman of test kit manufacturer Viet A Corp., said his company has enough supplies for 2 million PCR tests and were willing to provide enough kits for the country to conduct a widespread testing program.

Viet A had previously said it could ensure a supply of three million test kits monthly. The company did not provide more details in response to BioWorld’s queries.

In fact, Vietnam has done quite a significant U-turn where test kits are concerned.

In March, Vietnam initially struggled with widespread testing due to its limited health care budget and lack of equipment. It bought 200,000 tests from South Korea, but it also quickly developed its own test kits.

In May, Viet A claimed to have exported 20,000 of its test kit product to eight countries and was in negotiations with 20 other nations.

Hanoi-based Sunstar Joint Stock Co. also launched a new RT-PCR diagnostic kit in late April.

Launched under the name RT-PCR COVID-19 Thai Duong, the kit includes nine primer and probe sequences to detect three beta coronavirus target genes including SARS-CoV, SARS-CoV-2 and bat SARS-CoV.

"The new test kit has proved to have a 100% sensitivity, which detect the virus even at low levels, 100% specificity, which prevents cross reactions with other viruses and bacteria in the human respiratory tracks, and an agreement ratio of 100% following the process recommended by the World Health Organization (WHO),” said Doan Huu Thien, the head of the research group behind the Sunstar kit.

“It can even detect errors in the collection of samples, as well as safeguarding the entire diagnostic process.”

The main causes of false-negative results are errors committed when samples are taken.

The National Institute for Control of Vaccine and Biologicals of Vietnam (NICVB) helped to develop Sunstar’s kit to tackle this issue. Beside the use of diagnostic target genes, it included an internal control to detect human DNA in samples.

Any clinical samples that have been incorrectly collected will not have sufficient DNA in them and will be excluded. This way, there is a significant improvement in the percentage of false-negative results.

The test kit has completed trials at the National Institute of Hygiene and Epidemiology (NIHE) and the National Hospital for Tropical Diseases (NHTD) using 150 negative clinical samples, 35 positive samples, and 30 positive control mimic samples.

Negative test results are a source of increasing concern as in many cases, as some studies suggest an estimated 20%-30% of those tested have false-negative results.

The Vietnamese COVID-19 test kits have been well received so far. Sakshi Sikka, a senior pharmaceuticals and health care analyst at Fitch Solutions, described them as “effective, affordable and fast, diagnosing suspected infections in just an hour.”

“Using WHO-approved techniques, these test kits make it possible to isolate infected people and track down their contacts,” Sikka told BioWorld.

This is important not just to its med-tech industry but also to the country’s fight against the pandemic. Unlike other countries that rely on mass testing, in Vietnam tests are only done on those likely to be infected.

“At least 110 laboratories across the country can perform real-time polymerase chain reaction testing for COVID-19 diagnosis, with a capacity of 27,000 samples per day. As of April 30, 2020, Vietnam had conducted 261,004 tests, with 967 tests per positive case or 2,691 tests per million population,” she added.

The testing regime is related to a general push for medical self-sufficiency in Vietnam: “Even prior to the pandemic, the Vietnamese government's support for the local pharmaceutical industry was steadfast. This has been in part driven by the authorities' push to meet domestic health care needs,” said Sikka.

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