Rapid test kit – a murky landscape
– Ben Kiatkwankul
rkiatkwankul@mcg-asia.com
Thailand is in a serious need of an effective system to screen out those who are infected from those who are not. As experts constantly remind the public of a possibility of an exponential increase in the number of patients, ordinary citizens are living in fear of shortage for necessities – COVID-19 test equipment being one of many.
The relatively low number of cases in Thailand may not in any way represent the actual carriers of the virus who might have now scattered across the country after the partial lockdown of the capital. As the cases emerge, many public health analysts have suggested a thorough screening with speedy results and systematic provision of a closed arrangement whereby patients can be accommodated and treated separately to avoid further spread.
What test methods do we have now?
Currently, the public health personnel and officials are considering several potentials of COVID-19 test equipment, one being the polymerase chain reaction (PCR). Introduced during the onset of the pandemic and despite being one of the most reliable tests yet, PCR testing is still seemingly costly and too time-consuming for the increasing demand from anxious population as they flock into hospitals waiting in queues for the results to come out. This can take up to 48 hours where high-risk population will make their journey back home, exposing the risk to other people’s lives while traveling or those residing under the same roof.
Another major concern is the fact that there are ever-expanding circles of risk group around the country exceeding the capacity of the currently available test facilities. As of 31st March 2020, the Department of Medical Sciences (DMSC), Ministry of Public Health has authorized 57 medical labs around Thailand as Sars-COV-2 (or COVID-19) ready. Only 28 labs are concentrated in Bangkok (14 public hospitals, 14 private medical institutes), and 29 are scattered around the country (27 public, 2 private). With the shortage of facilities, the public is calling for a more time-efficient and safer methods.
The Issues with "Rapid" Tests
While countries are in a quest for a vaccine or a cure, the so-called “rapid tests” are introduced as a quicker alternative. The main types of rapid tests differ in the bio-substances, namely one type detects antibody, another antigen. These rapid tests are not without flaws, and the problem in the name can lead to misconception.
Popularly coiled “rapid”, some medical device producers using these new methods boast their test kits to be able to show results within less than an hour. While those who have contracted the virus can start spreading the illness from day 1, rapid tests will need 5 to 10-day window period of infection before the test can diagnose the infection. Some of the rapid test kits have been made available on the online market, to which the government has voiced out against it straight away and imposed control for it to be sold through certified pharmacies and hospitals.
Rapid test gave a slight beam of hope for the population as the DMSC approved the marketability of at least 5 rapid tests, all imported from China PRC.
Notwithstanding the hope rapid tests will provide a timelier method of screening, the immediate halt on the roll out of rapid tests in Spain amidst the sky-rocketing number of cases has shook the confidence off the Chinese-made products, alarming the Thai administration and the international governments alike. The announcement released by the Chinese Embassy itself in Spain claimed that Shenzhen Bioeasy Biotechnology had not yet been licensed by the Chinese National Medical Products Administration. The Chinese government however countered with the argument that they have provided the Spanish government with a list of certified producers, which the Spanish did not fully observe.
Thai authorities have approved 3 rapid test kits from Shenzhen Bioeasy Biotechnology:
To be imported by MP Med Group and Bangkok Genomics Innovation;
2019-Novel Coronavirus (2019-nCoV) IgG/IgM Rapid Test (Colloidal Gold)
Diagnostic Kit for 2019-Novel Coronavirus (2019-nCoV) Ag Test (Fluorescence immunochromatographic Assay)
To be imported by Bangkok Genomics Innovation;
2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test (Colloidal Gold)
30th March - the Minister of Public Health established a working committee to investigate the legitimacy of the approval procedure conducted by the Thai FDA and DMSC on Shenzhen Bioeasy Biotechnology's rapid test kits. While the investigation is in progress, MP Med Group has announced its withdrawal of import license for products from the Chinese company in question.
RT-PCR as the way forward for Thailand?
Thailand’s authorized labs presently use the SARS-CoV-2 Real-Time PCR (RT-PCR) method which can provide result in 3 hours. Should the patient be tested negative, s/he is advised to retest for accuracy; should however the patient be tested positive, the nucleotide sequencing method is employed to confirmed the infection. Result will come out within 24 hours. There are 16 DMSC-approved solution liquids available in Thailand to conduct RT-PCR.
Government spokesperson reassured that with the current facilities and equipment, if used efficiently, up to 10,000 cases can be tested in Bangkok and 10,000 more outside of Bangkok daily. Still, in order to fulfil what critics have suggested, the current capacity falls short of the population that needs to be screened.
Recently, Chulalongkorn University has presented the Prime Minister with proprietary rapid test kits, “Chula COVID-19 Strip Test Service”, an IgG & IgM serology test as another alternative for preliminary blood test. The test kit is developed by networks of Chulalongkorn academics and alumni, public and private sectors, including Thailand Tech Startup Association, and Baiya Phytopharm Co., Ltd. Another beam of hope comes from King Chulalongkorn Memorial Hospital aims to bring at least 50,000 units of US-FDA-approved SARS-CoV-2 test reagent for gold standard RT-PCR testing method by Roche into Thailand. The reagent has been proven to work accurately with COBAS 6800/8800 (fully automation LIS/HIS testing device costing over THB 20 million). The method is capable of reading over 1,400 specimens consecutively per day, and results are claimed to be of 99.8% accuracy. There are approximately 20 COBAS 6800/8800 in Thailand.
The root cause in the bureaucracy ...
Throughout the public and private effort to mitigate the crisis, one of the persistent issues lies in the process for importation of devices and equipment necessary for medical personnel to serve population in need. Most COVID-19 test kits are categorized as medical device, and fall under the control of the Medical Device Act B.E. 2551 (2008). The approval process for producing or importing such equipment need to be granted by the FDA with consultation with the DMSC. The Cabinet has approved the exemption of import duties of surgical masks under the HS Code 6307.90.40 and 6307.90.90. With the recent recalls of substandard products, COVID-19-related equipment is however, still being heavily monitored by the government putting extra burden on entities seeking approval for importation and production. The Thai Customs Department will consider the exemption of import duties of devices used to treat, diagnose and prevent COVID-19 as the next immediate measure to mitigate the crisis.
What remain to be seen
Despite all potential capacity for Thai medical institutions to conduct screening and quarantine, the record during the week beginning March 15 by WHO for total COVID-19 tests performed in Thailand remain relatively low at a little over 7,000 cases, only half of that conducted by Malaysia at approximately 13,800, and Vietnam at 15,600.
The World Bank projected that the Thai national economic growth would be hit most drastically amongst the Southeast Asian neighbors at -3% to -5% at the worst. Thailand needs to balance their effort to contain the spread of the virus as quick as possible while trying to recover the economy. As of 1st April, the number of COVID-19 patients gradually exceeds 2k mark at 1,771, with 12 fatalities. We are to see whether the relatively low number reflects the actual situation, or the “technical difficulties” faced by the good medical personnel results in yet another April fools’.