By CodeBlue
KUALA LUMPUR, April 17 — Two doctors’ groups have suggested using either antibody or antigen rapid tests to screen some 400,000 workers approved during the third phase of the Movement Control Order (MCO).
The Malaysian Medical Association (MMA) said it supported the government’s announcement in using the rapid antibody test kit for those who are returning to work, while the Federation of Private Medical Practitioners’ Associations, Malaysia (FPMPAM) highlighted antigen rapid tests that can detect early Covid-19 infection.
Both tests have minutes-long turnaround times and can be done in clinics instead of sending samples to laboratories, compared to the gold-standard PCR tests that take 24 to 48 hours to yield results at laboratories.
MMA urged the Ministry of Health (MOH) to announce a list of reliable tests for use at private general practitioner (GP) clinics to test these workers, since no antibody rapid test kit has been approved for diagnosis of Covid-19 so far.
“This is a point-of-care testing which is done at the clinic itself unlike the antigen test that is done by taking the nasopharynx and oropharynx swab, which needs full personal protective equipment (PPE) and needs training with MOH,” MMA president Dr N. Ganabaskaran told CodeBlue.
“To conduct the finger-prick procedure may take less than three minutes and waiting time for the results is 10 to 15 minutes.”
When pointed out that antibody tests are not recommended for coronavirus diagnosis, as antibodies take days to weeks to develop after a viral infection, Dr Ganabaskaran said these serology tests are meant for screening people returning to work who are not Covid-19 patients-under-investigation (PUI).
Serology tests identify antibodies to the virus that causes Covid-19, whereas antigens are viral proteins expressed only when the virus is actively replicating, so tests based on antigen detection can identify acute or early infection.
“We believe MOH will issue clear guidelines and also interpretation criteria before it’s rolled out,” Dr Ganabaskaran said.
He pointed out that a South Korean antigen rapid test kit that will be procured soon by MOH cannot be used in private GP clinics at the moment as these facilities lack full PPE and biosafety cabinets.
“The GPs are already used to conduct other point-of-care testing like dengue serology which is done using similar methods. The only difference is the GPs need to pre-qualify them as non-PUI and wear appropriate PPEs like face mask, face shield, disposable gloves and a plastic apron,” he said.
The MMA president also said clinics would question patients before testing to get their travel history, symptoms, or possible links with Covid-19 patients, adding that the 3,000 GP clinics identified to screen the 400,000 workers had sufficient testing capacity.
“We believe majority of these workers are in urban and semi-urban area, of which the 80 per cent of clinics are well distributed.”
Tests Only Mandatory For Newly Approved Workers
International Trade and Industry Minister Mohamed Azmin Ali announced yesterday that all workers of companies allowed to operate during the third phase of the MCO are required to undergo Covid-19 screening at any of the Social Security Organisation’s (Socso) over 3,000 panel clinics nationwide. He said Socso will bear the cost of screenings.
An International Trade and Industry Ministry official told CodeBlue that the coronavirus tests were only mandatory for newly approved workers during MCO 3, not those who were already allowed to operate during the earlier phases of the nationwide partial lockdown.
The number of workers from the additional sectors allowed to reopen during the third phase of the MCO are estimated at 400,000, he said. These sectors are the automotive industry; machinery and equipment industry; aerospace industry; construction projects; science, professional and technical services; social health services; hardware shops and electrical and electronic shops; and full-service laundry services.
“Still, not all companies will open operations. Some may just wait till MCO over,” he said.
Testing In Private Clinics Includes Various Costs
FPMPAM urged the government to expand Covid-19 testing for the 400,000 workers to all 7,000 over private family doctors, including those on the Fomema panel. Fomema is a concession company appointed by the government to provide medical examinations for foreign workers in Malaysia.
“To be practical and meaningful, these 400,000 workers will need to be checked and screened as soon as possible. If they are already in the country this will have to be done within a week or so.
“It would work out to more than 10 patients per day for each clinic. This is a massive undertaking,” FPMPAM president Dr Steven Chow told CodeBlue.
Instead of antibody rapid tests, FPMPAM highlighted the currently approved antigen rapid test kits with a turnaround time of 30 minutes.
“The question is whether there is enough stock of these approved tests in the country to cater for 400,000 tests in the weeks to come. Can this be delivered to all the participating clinics nationwide?” Dr Chow questioned.
He highlighted the requirements for a biosafety cabinet and training with Cawangan Kawalan Amalan Perubatan Swasta (CKAPS) in Putrajaya. Dr Chow said.
“The logistics and the fulfillment of the present requirements for Covid-19 testing in private health care facilities will be the bottle-neck and a Catch-22 for its implementation,” he said.
According to FPMPAM, tests currently cost RM50 each, with a minimum doctor’s fee at RM30 per patient, including clinical consultation and examination. This excludes the cost of a biosafety cabinet, PPE and supplies, extra staff, time spent on prerequisite training, and disinfection if Covid-19 cases turn up.
“Will the cost of all this be borne by Socso?” Dr Chow questioned.
“Presently the cost per test per patient is about RM300 when done by mobile teams visiting the place of work. Imagine you have a factory employing 1,000 workers, this is already a disincentive for businesses to restart operations.”
He also asked what would happen if private clinics found positive Covid-19 cases.
“What treatment is the GP allowed to give? Will all the positive cases need to be referred to the government hospitals? As with existing SOP, in the event of any positive case, the doctor and all clinic staff will need to get themselves screened, clinic to be closed and quarantined for 14 days even if negative.
“The operational income will be disrupted for the next 14 days, but operational expenditure will need to be met,” he said.
FPMPAM said the best approach was routine medical screening for all workers and certification by their own company doctors and for the company doctor to do the needful if cases that need further investigation are suspected.
“A question that is often asked is, will all government employees be required to be tested before they resume work following the MCO?”
The Ministry of Human Resources and Socso have yet to reply CodeBlue’s questions about the matter at the time of writing.
https://codeblue.galencentre.org/2020/04/17/antibody-antigen-rapid-tests-mooted-at-private-clinics-for-400000-workers/
MOH Sends Socso Covid-19 Testing SOP For Workers
By MP Durgahyeni
The Ministry of Health recommends PCR tests or rapid antibody tests at private or Socso panel clinics to screen workers for Covid-19.
KUALA LUMPUR, April 24 – The Ministry of Health (MOH) has advised the Social Security Organisation (Socso) on Covid-19 screening procedures and suitable tests at private clinics for workers returning to work.
Health director-general Dr Noor Hisham Abdullah said the Covid-19 screening for workers from industries approved to operate during the Movement Control Order (MCO), of which Socso will bear the costs, could be done at private or Socso panel clinics, using MOH-collaborating private laboratories, through PCR tests or rapid antibody tests.
“At the same time, MOH recommends that all Socso panel medical practitioners take complete medical history, including overseas travel history, exposure to positive Covid-19 cases, and attendance at any gathering or exposure to people who attended gatherings,” Dr Noor Hisham said in a letter to Socso CEO Mohammed Azman Aziz Mohammed on April 21, as sighted by CodeBlue.
According to MOH’s screening standard operating procedure (SOP), if the PCR tests for coronavirus show negative, workers can start working. But it is positive, they will be treated as Covid-19 patients as per MOH guidelines.
PCR tests in the private sector cost between about RM400 and RM700 for individual users, and take 24 to 48 hours to yield results at laboratories.
As for the antibody test, also known as serology tests, MOH recommended the usage of serology rapid test kits (RTK) that are validated by Institute of Medical Research (IMR) or the National Public Health Laboratory (NPHL). The rapid antibody tests recommended are Lionrun Shanghai Liangrun Diagnostics Kit, Wondfo, Vazyme, Standard Q Covid-19 igM/IgG Combo, and Healgen.
Even if the antibody test shows negative, the worker is still not allowed to go to work and will have to retake the test on the seventh day since the first testing. If it shows negative again, only then can the worker resume work. If the serology RTK shows positive, whether on Day 1 or Day 7, clinics are ordered to perform a nasopharyngeal swab for PCR testing on the worker.
“All PCR positive result must be treated as Covid-19 positive patients, as per MOH guidelines,” said Dr Noor Hisham’s letter.
On RTK for antigen detection, clinics are recommended to use tests that are validated by IMR or NPHL. The recommended MOH test is Standard Q Covid-19 Ag SD BIOSENSOR.
MOH noted, however, that rapid antigen tests need the usage of biosafety cabinets and may not be suitable to be used in private clinics.
If the rapid antigen test shows negative, workers can go to work. If it is positive, workers will not be allowed to go to work and will be referred to the hospital.
Dr Noor Hisham said the list of recommended tests, which will be reviewed every two months, was based on testing sensitivity and specificity.
Doctors’ groups previously suggested using rapid antibody or antigen tests, both of which have minutes-long turnaround times that can be taken in clinics without needing to send samples to laboratories. The serology test simply requires a finger-prick to get a drop of blood, whereas antigen tests need a nasopharynx and oropharynx swab, biosafety cabinets, as well as trained medical staff wearing full protective gear. Most general practitioner (GP) clinics do not have full personal protective equipment (PPE).
The Malaysian Medical Association has said GP clinics had sufficient testing capacity in antibody tests to screen some 400,000 workers, most of whom are likely based in the cities or sub-urban areas where private clinics are also located.
The Ministry of International Trade and Industry said an estimated 400,000 workers were approved for work during the third phase of the MCO that ends on April 28. Prime Minister Muhyiddin Yassin said yesterday that more business sectors may be reopened when the partial lockdown is extended from April 28 to May 12.
https://codeblue.galencentre.org/2020/04/24/moh-sends-socso-covid-19-testing-sop-for-workers/
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