The German city of Hamburg recently decided to stop the use of COVID-19 rapid antigen testing kits from Korean-based firm SD Biosensor.

The move came after German media company Welt revealed that the over 2 million tests acquired by the city government from SD Biosensor contain the potentially poisonous substance octylphenol. The European Union identifies octylphenol as a Substance of Very High Concern (SVHC) and as a possible toxin.

The Hamburg government acquired the antigen tests as part of a batch of six million rapid tests of various brands to be used by authorities, schools and daycare centers. The total acquisition cost was over €9.8 million.

The SD Biosensor test kits were reportedly modified so that they may be used as self-tests. In some German schools, the kits were administered by the students themselves under the supervision of their teachers instead of health professionals.

School authorities defended the use of the testing product, saying that almost no other test kit brands were available in quantity at the time of acquisition. The German distributor, Roche, says the SD Biosensor product is safe if used properly.

Meanwhile, some district schools have already dropped the test following the government’s decision.

This is not the first time that SD Biosensor products had been pulled from usage. In July last year, the Indian Central Drugs Standard Control Organisation (CDSCO) banned the use of SD Biosensor’s Standard Q Covid-19 IgM/IgG Duo in July. The United States Food and Drugs Administration also decided in June to ban the test kits. With all these, one wonders why German authorities decided to accept the test kits in the first place.

SD Biosensor however is approved by local authorities for use in the Philippines.

Before the current debate on vaccine effectiveness, the early days of the COVID-19 pandemic were marked by questions on the safety and accuracy of various COVID-19 testing methods. Doctors are among those who questioned the accuracy of rapid antibody tests. Questions were raised even on the Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, although the Department of Health still considers it the gold standard.

I have no intention of undermining any company or their chances of doing business in this country. However, as the SD Biosensor case demonstrates, there are products that have been declared unfit in more advanced countries, but have somehow slipped through scrutiny in our country. If Welt’s claim that the product in question contains a toxic substance is true, why isn’t there any effort to have it reviewed again and removed from circulation if necessary?

With the attention of most people on vaccines these days, there seems to be a need to refocus attention on the quality of testing methods. The DOH and FDA have approved numerous testing kits of various types.

With this year’s summer surge of COVID-19 cases, some may question whether the numbers are accurate. Some may raise the issue whether the test products are providing accurate results.

To be fair, the DOH at least counts only PCR results for its nationwide COVID-19 statistics. But some local governments and institutions find access to PCR prohibitive and, as a result, resort to using other test types. Antigen testing is required in some local governments and institutions and clients are directed to go for PCR only when the antigen result is positive.

However, confusion can rise from non-PCR and PCR test results differing from each other. Which one is right? Despite PCR being the only one counted for positive results, could it be possible that the antigen test is right and the PCR one is wrong? What if they are both wrong? This can indeed be confusing and worrying at the same time.

The FDA is expected to screen out products of dubious performance and protect the public from possible harmful effects as well as doubts on accuracy. If some defective or poor quality products slip through the cracks despite intense screening, then the repercussions might be bigger than we think.

We all want the best, safest, most accurate and more reliable COVID-19 test to be used. However, more vigilance is required to ensure this. Perhaps more attention should be given to questionable products that may have slipped through FDA screening. There may be more than the product mentioned above. We should also ensure that approved products have not been rejected elsewhere in the world.