HEALTH Department director general Dr Noor Hisham Abdullah in his daily address today stated there was a delay in the arrival of 200,000 antigen rapid test kits for Covid 19 from South Korea, which were supposed to arrive yesterday and will now, supposedly, arrive next week.

However, we discover some quite baffling details, including a possibility of some alleged misinformation with regard to the procurement of test kits by the government, as revealed in this expose.

THERE are two commodities the world is scrambling for at the moment, as manufacturers struggle to up their game to meet explosive demand – personal protective equipment (PPEs) and Covid 19 rapid test kits (RTKs), more specifically the antibodyRTKs and polymerase chain reaction (PCR) test kits.

And just like any commodity, the power play involved sees the world’s top bullies like the US and their European counterparts, are putting exposing all their financial clout in order to block off supplies in order to boost their own battles against the Covid 19 pandemic.

Yesterday we reported the depleting supply of PPEs, in particular N95 category face masks, of which the world is facing shortage of supply and Malaysia’s Covid 19 front liners were dealt a blow when a shipment of KN95 face masks acquired through some allegedly questionable processes were allegedly rejected for use by the Health Ministry after failing fit tests.

In short, the KN95 face masks, said to have been sourced from a Chinese manufacturer, were unsafe to be used to protect front liners against contracting Covid 19 from the patients they treat. As such the RM20 million shipment of PPEs was relegated to use as surgical masks in regular medical services. For that story, follow the link below.

An eye-opener

Those in Malaysia’s front line battle against Covid 19 have already voiced their concern over the depleted supply of PPEs, vital for their own defence against coronavirus infection, but now comes the question of how mass testing both by the Health Ministry and screening of employees set to return to work in industries given approval to resume operations under the Movement Control Order (MCO).

Here comes some explosive news in that Dr Noor Hisham, the face of Malaysia’s battle against Covid 19, may have himself been deceived by those involved in procurement.

Our contact, who shall be known as Korean Official 1 (KO1), linked to South Korea’s largest distributor of SD Biosensor, the largest manufacturer of antibody RTKs and PCR test kits in that country.

*Go to the end for images explaining of how MOH has on its list SD Biosensor’s antigenRTK as an approved antigen type test kit, while SD Biosensor’s antibodyRTK and PCR are not. Even more baffling is the fact that antibodyRTK from non-WHO approved sources are on the list!

KO1 reveals firstly, that it is unlikely that any order of 200,000 antigenRTKs from South Korea is unlikely to be fulfilled, especially since all factories in that country had stopped producing those kits since last month, as all production lines focused on antibodyRTKs and PCRs, which are deemed more suited to dealing with a pandemic.

Questions for Dr Noor Hisham to ask those involved in procurement on behalf of the government, is why KO1 states there were in fact no orders of antigenRTKs from Malaysia, let alone the government, even if the likelihood of them being produced is now deemed as zero.

It seems the only reason antigenRTKs could be the test kit of choice for Malaysia’s procurement troops is price. But at a time when the world is paying 10 times the market price for N95 face masks just to keep their front liners safe, a double whammy has been dealt as KO1 explains:

  1. Antigen Kits have ceased production since March.
  • All the production lines have been used for Antibody and PCR. (no room for antigen)
  • Not a single kit has been made in April and especially never sent out from the factory. We will know if any numbers go out to Malaysia, SD Biosensor will notify us before the actual export from Korea.
  • Recently there was a request of claiming themselves as Malaysian government and asking for the price of Antigens but payment never came nor can be accepted because production has been stopped until end of the year or more.
  • In any case, the SD factory cannot deliver any antigen kits as an order of US$270 Million from USA is in the production line of the Antibody kit. There is simply just no way to change production line for small number of antigen requests compared to the USA’s.
  • The world is ordering PCR type and Rapid Antibody kits only because they are more functional, high range of coverage for all patients and early symptoms than what Antigens can cover.
  1. SD have requested for the certificate of FDA for two products: Only PCR type & ANTIBODY RAPID TEST KIT.
  • As of today, it was reported in the media that SD Biosensor got the actual FDA (US Food and Drug Administration) approval for PCR TYPE.
  • As for the Antibody rapid kit, it is in the process for FDA approval and as in now it is a temporary approval because of USA market.
  • As for Antigen kits, never been sold and never has been attempted to get the FDA approval at all. This is not only SD biosensor, but (other South Korean) companies like Genbody, Seegen etc.

KO1 goes on to explain why the South Korean machinery is now dedicated to production of PCR and antibodyRTKs.

“At the time of a pandemic, PCR and Rapid antibody kits are strongly recommended. USA and all of Europe is only purchasing and looking for Antibody rapid kit and PCR type,” KO1 wrote.

“Due to the massive new US$270 Million order from the USA, Antigen kits will not resume it’s production or setting up a production line until beginning of next year even if orders come in big quantity.

“Factory lines for will not be switched from antibody and pcr type kits to antigen.”

He says this is due to the advancement made in the development of antibodyRTKs and PCRs, which can cover the whole range of antigen tests, thus eventually production of antigen test kits will be stopped permanently.

Thus, following Dr Noor Hisham’s statement today (as per video below), about a shipment of antigenRTKs expected to arrive from South Korea, we would strongly suggest for his team to check what those in charge of procurement are up to.

Dr Noor Hisham informs the nation about a shipment of 200,000 antigenRTKs from South Korea being delayed and set to arrive next week. We believe this needs to be checked.

And then comes the question of senior Minister (economic affairs) Azmin Ali’s announcement last week, that employees serving industries approved to resume operations under the Movement Control Order (MCO) were to undergo screening at 3,000 Social Security Organisation (SOCSO/Perkeso) panel clinics.

While Dr Noor Hisham had aptly announced an extensive list of Health Ministry guidelines and standard operating procedures for these industries to adhere to, the preparedness of the clinics, their staff and again, the sufficient supply of WHO (World Health Organisation) approved test kits again comes into question.

For certain, antigen kits are not coming from South Korea. While world governments are purchasing, according to KO1, only antibody and PCR test kits.

And if these antigenRTKs are coming from countries other than South Korea, then apart from Dr Noor Hisham’s statement about them coming from there being wrong, there is also a question of whether the Health Ministry, as our medical industry contacts suggest, are treading on a dangerous path with non-WHO approved test kits as per excerpt from a WHO circular below.

A list of Covid 19 test kits, which the World Health Organisation (WHO) does not endorse. Note Guangzhou Wondfo in this list.
Note Nanjing Vazyme in this WHO list.

Now, let’s have a look at a list approved by the Ministry of Health of Malaysia, with the cover letter and other attachments subsequent to that.

Note that at least non-WHO endorsed test kits approved by MOH.

Also note, that the SD Biosensor antigenRTK is on the MOH list, while the company itself, as we have revealed above, has no idea and is neither producing these test kits anymore and instead are producing antibodyRTKs and PCRs which are recommended the world over, but somehow are not on MOH’s list!

More to follow…