Emergency Diagnostic Kits Ignored On Site... "Inappropriate for Use on Emergency Patients"

Authorities Approve 3 Diagnostic Reagents for Emergency Surgery and Delivery Patients
Medical Field: "Only Shortens Existing Process... Difficult to Use for Emergencies"

Yeungnam University Hospital Emergency Room

[Asia Economy Reporter Choi Dae-yeol] Emergency diagnostic kits introduced to quickly determine infection status when patients about to give birth or undergo emergency surgery are suspected of having COVID-19 are being neglected in frontline medical settings. Although about ten days have passed since the authorities approved emergency diagnostic kits in late June, it is reported that no medical or testing institutions have officially adopted them yet.

According to the medical community on the 5th, 13 products were submitted following the authorities' call for applications for emergency use approval of diagnostic kits in early last month. Among these, three domestic diagnostic kits, including SML Genitree, received emergency approval after document evaluation. The authorities stated that they are reviewing whether to grant additional approvals for the remaining 10 products.

The officially recognized COVID-19 confirmation test by domestic health authorities is the molecular diagnostic method called real-time RT-PCR. This method collects specimens from the throat and inside the nose, amplifies them, and checks for the presence of the virus to determine infection status, taking about six hours. Compared to January, when COVID-19 patients first appeared and the process took about two days, this is considerably faster.

Specimens are being collected for a full PCR test survey targeting conscripts.<이미지:Yonhap News>

However, there have been consistent calls for a faster method when patients suddenly injured requiring major surgery or those about to give birth show symptoms suspicious of COVID-19, such as fever, respiratory symptoms, or unexplained pneumonia. This is the background for introducing emergency diagnostic kits. Accordingly, the authorities decided to adopt a diagnostic testing method that takes less than an hour and accepted applications. After screening, three products were selected, but medical sites have commented that these are "not suitable for use in emergency patients."

Pneumonia symptoms observed in Gyeongsan but COVID-19 suspected
Unable to receive timely treatment while waiting for test results
"Must be useful in emergency situations"

Professor Lee Hyuk-min of Yonsei University College of Medicine, who leads the COVID-19 task force at the Korean Society for Laboratory Medicine, said, "The recently approved emergency diagnostic kits are modified versions of the existing RT-PCR method, so if the existing testing equipment is running, new emergency patients cannot be tested," adding, "These products are difficult to use in emergency situations."

There are also doubts about whether the test results can be trusted. Since the tests are conducted in the same way as before but with some steps omitted or shortened to reduce time, reliability is inevitably questioned. A diagnostic expert said, "If the existing PCR method amplified 40 to 45 times, the newly approved emergency diagnostic kits claim that about 30 times is sufficient," adding, "Some companies failed to receive emergency use approval for general diagnostic kits but obtained it this time, so it is hard to consider the test results reliable."

Citizens are waiting for testing at the Yangji Hospital screening clinic near Wangseong Church in Gwanak-gu, Seoul, where a cluster infection case of the novel coronavirus disease (COVID-19) has occurred.

Recently, as COVID-19 patients have increased nationwide, the number of contacts and suspected cases has also risen, with over 10,000 diagnostic tests conducted daily. Even if emergency diagnostic kits are distributed to frontline sites, they will not widely replace existing methods. However, for patients requiring emergency surgery where every second counts, there is a call for a proper emergency kit as soon as possible to avoid wasting time determining COVID-19 infection status.

This is because the story of a high school student in Gyeongsan who showed pneumonia symptoms in March but died after failing to receive timely treatment while waiting to confirm COVID-19 status could happen again at any time. Professor Lee said, "Overseas, there have been cases where many medical staff in operating rooms were infected while performing surgery on COVID-19 patients," adding, "Considering the many asymptomatic cases of COVID-19, a reliable diagnostic kit that can be trusted even in emergency situations must be prepared."

This content was produced with the assistance of AI translation services.