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Accreditation of Private Laboratories to perform

COVID-19 rRT-PCR

The first engagement with private laboratories and universities was held in early March in
MKAK Sg Buloh. We invited them for training and asked whether they can offer testing.

Both IMR and MKAK are involved in the accreditation of private laboratories to perform
COVID-19 rRT-PCR. Initial stage, they have to show that their laboratories are able to detect
the SARS-CoV-2 screening gene target and confirmation gene target, show their sigmoidal
curve and testing report. Then we will provide the known positive samples for testing as the
first line of evaluation. Once the laboratory has shown that they can detect the positive
samples and provide the graph (basic model), then IMR will provide the blinded samples
(some are positive and some are negative) to see if they can detect according to our Ct values.
This is the second line of evaluation. Once the laboratories started to provide COVID-19
testing service, they also had to send the first 5 positive and negative COVID-19 samples to
IMR to see correlation. This is the third line of evaluation. After they passed all three
evaluations, these laboratories will be listed in the Laboratories Guidelines Annex 4a [1]. The
private laboratories listed in Annex 4a is to notify people who want to send their samples to
the accredited private laboratories. This will help to increase the testing capacity in the
country.