Page 175 - MALAYSIA HEALTH SECTOR RESPONSE TO COVID-19 PANDEMIC: PERSPECTIVES FROM THE FIELD

Besides, IMR is also conducting a similar ongoing study to develop a simple
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close-tube RT-LAMP assay for COVID-19 that can be carried out by personnel
with minimal training and without needing any sophisticated equipment.
Therefore, an in-house diagnostic assay developed with minimal machine-
dependence should be preferable for detecting SARS-CoV-2 in the local
setting.

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Unfalteringly exploring other alternatives, IMR conducted a study to
evaluate the performance of the COVID-19 in vitro diagnostic test kits for
the detection of the COVID-19 antigen RNA by reverse transcriptase
polymerase chain reaction and antibody. Of the 43 RT-PCR test kits received
for evaluation, 69.7% (30 kits) met the acceptance criteria. Meanwhile, for
antibody and antigen kits, the percentage of test kits that reached the
acceptance criteria for local marketing was 34% (15/44) and 33.3% (4/12),
respectively. The final decision on the test kit's approval would be decided
by the Medical Device Authority (MDA) expert committee, based on the
performance report published by the IMR laboratory.

Exploring alternative specimens for the detection of SARS-CoV-2

The comparability of patient-performed testing using a morning saliva
sample with the current standard testing method of sampling via a
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nasopharyngeal swab (NPS) done by a HCW was also explored by IMR . The
findings demonstrated that saliva was a better alternative specimen for the
detection of SARS-CoV-2. Considering the simplicity of specimen collection,
shortage of PPE, and the virus's transmissibility, saliva sampling could assist
in the sampling protocol, management of patients, and reduce the hazard
exposure among HCWs. Furthermore, the detection rate of SARS-CoV-2
between healthcare worker-collected nasopharyngeal and oropharyngeal
(NP+OP) swabs compared to that of patient-performed self-collected
random saliva was also assessed in another IMR study . The findings
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demonstrated that random saliva was a better alternative diagnostic
specimen for detecting SARS-CoV-2; however, it might be subject to several
limitations as well.

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