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TAN KIAN SHING, MIMLS (Mal)
B.Sc (Hons) Biotechnology

UCSI University, Malaysia
Assistant General Manager
Synapse Laboratory (Synapse Sdn Bhd), Malaysia
Medical Laboratory Scientist with over 10 years of scientific and
managerial experience in medical diagnostics industry
Particular interest in Nucleic Acid Amplification Testing (NAT) for
Hepatitis B, Hepatitis C and HIV, Newborn Screening for Inherited
Metabolic Diseases (IEM) and Molecular Studies of Thalassaemia
Honorary Secretary
Malaysian Institute of Medical Laboratory Sciences (MIMLS)
SARS-CoV-2
Antigen Testing:
Preanalytical
and Analytical Considerations
TAN KIAN SHING BSc (Hons), MIMLS (Mal)
Assistant General Manager, Synapse Laboratory (Malaysia)
WEBINAR PATELKI IX
Honorary Secretary, Malaysian Institute of Medical Laboratory Sciences (MIMLS) 28 June 2020
SYNAPSE SDN BHD is a medical laboratory and healthcare group with
strategic focus on development and implementation of reference
technologies for healthcare testing.
• Facilitate innovative new technologies in medical sciences with focus on
molecular diagnostics
• Provides medical testing services to government and private hospitals, clinics Head Office + Laboratory:
and healthcare institutions throughout Malaysia Unit 203 & 205, Block D, Kelana Square,
Our Services: 17, Jalan SS 7/26, Kelana Jaya,
• Nucleic Acid Amplification Testing (NAT) for Hepatitis B (HBV), Hepatitis C (HCV) and HIV 47301 Petaling Jaya, Selangor, MALAYSIA.
• Newborn Screening for Inherited Metabolic Diseases (IEM) T: +603-7880 8730 / 8820
• Molecular and genetic testing services F: +603-7880 8750
• Research and experimental work www.synapselaboratory.com
Advancing Excellence In Healthcare Testing

COVID-19 Testing
by Synapse Laboratory
In light of the recent COVID-19 pandemic caused by SARS-CoV-2, Synapse Laboratory has set up testing
for COVID-19 in our laboratory to help expand testing capacity for the infection in the country.
• One of the private laboratories certified by Ministry of Health Malaysia to perform COVID-19 rRT-PCR testing
• Offers a comprehensive testing solution for COVID-19 that can meet the needs of patients, healthcare professionals,
employers and even third-party administrators
COVID-19 Triple Gene Real-Time RT-PCR

• Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) technology for detection of SARS-CoV-2 from suspected patient’s
nasopharyngeal and oropharyngeal swab sample
• Simultaneous detection of both E gene and RdRp gene RNA, as recommended by the World Health Organisation (WHO), as well as N gene RNA
COVID-19 Antigen Test

• Rapid Chromatographic Immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 in human nasopharynx
• Using rapid testing kit that has been validated by the Institute for Medical Research (IMR) and National Public Health Laboratory (MKAK), Ministry of
Health Malaysia for screening of COVID-19
Advancing Excellence In Healthcare Testing

COVID-19 Pandemic in Malaysia
A Quick Glance
• 24 Jan 2020: National Public Health Laboratory (MKAK)
detects the first 3 imported COVID-19 cases in Malaysia
from contact tracing based on communication from
Singapore.
• Institute for Medical Research (IMR) detects 1 positive case
in a symptomatic patient (Patient Under Investigation).
• 3 Feb 2020: First Malaysian tests positive for COVID-19
(Case No. 9) with history of attending a conference in
Singapore involving delegates from China.
• 6 Feb 2020: Malaysia records its first human-to-human
transmission of COVID-19.
• 16 Feb 2020: Case No. 22 marks the last case in the first
wave and Malaysia subsequently experience zero case until
11 days later – the 2nd wave. Source: The COVID-19 Chronicles of Malaysia, National
Institutes of Health, Ministry of Health Malaysia
A Quick Glance
• 27 Feb 2020: MOH detects 1 case - the starts of the
2nd wave.
• 27 Feb - 1 March 2020: A religious event took place at
a mosque in Sri Petaling, Kuala Lumpur and
subsequently become the country’s largest cluster -
The Sri Petaling Cluster.
• 11 Mar 2020: The International Health Regulations
(IHR) Focal Point for Brunei informs Malaysia of the
travel history of a case detected in Brunei Darussalam.
The patient had attended a religious gathering in Sri
Petaling. Estimates gauge 10,000 individuals from
several countries, including Malaysia, participated in
this gathering.
Source: The COVID-19 Chronicles of Malaysia, National
A Quick Glance
• 16 Mar 2020: Malaysian Government announced
Movement Control Order (Perintah Kawalan
Pergerakan) - a nationwide lockdown effective 18
March 2020.
• 17 Mar 2020: Malaysia sees first 2 death cases from
COVID-19.
• 25 Mar 2020: Movement Control Order extended for
14 days. Subsequently extended to 28 April 2020,
followed by Conditional MCO till 9 June 2020.
• 10 June 2020: Malaysia entering into Recovery
Movement Control Order (Perintah Kawalan
Pergerakan Pemulihan) through August 31, 2020.
Source: The COVID-19 Chronicles of Malaysia, National
Source: MOH Malaysia
Source:
Source: Kenyataan Akhbar Ketua Pengarah Kesihatan 26 Jun 2020 – Situasi Semasa Jangkitan Penyakit Coronavirus 2019 (COVID-19) di Malaysia
COVID-19 Testing in Malaysia
• Real-Time RT-PCR
• Performed by 53 laboratories in Malaysia:
• Virology Unit, Institute for Medical Research (IMR),
MOH
• 14 State Hospitals, MOH
• 5 Public Health Laboratories (MKA), MOH
• Hospital Angkatan Tentera Tuanku Mizan (Military
Hospital), MinDef
• Malaysia Genome Institute, MOSTI
• 14 universities and university hospital’s laboratories
• 17 private medical laboratories evaluated by MOH
• Real-Time RT-PCR
• Gold standard
• Detects presence of SARS-CoV-2 RNA
• E gene and RdRp gene RNA as recommended by WHO
• Some with additional N or S genes
• Sample type:
• Nasopharyngeal (NP) AND Oropharyngeal (OP) Swabs
in Viral Transport Medium (VTM)
• Sputum (if produced), tracheal aspirate or
bronchoalveolar lavage (for symptomatic patient)
• Used to detect current / on-going infection
• Antigen (RTK)
• Using Rapid Test Kit which has been validated by
Institute for Medical Research (IMR) and National Public
Health Laboratory (MKAK), MOH
• Performed by laboratories with Biosafety Cabinet (BSC)
• Screening at country’s entry point at KLIA and KLIA2 and
for transit passengers to Sabah and Sarawak
• For Sabah and Sarawak: Vast and logistics are challenging
• Detects presence of viral proteins
• Sample type: Nasopharyngeal swab
• Used to detect acute / early phase of infection
• Antibody (RTK)
• Using Rapid Test Kits which has been validated by
Institute for Medical Research (IMR) and National Public
Health Laboratory (MKAK), MOH
• Detects presence of antibody in infected individuals
• Day 13 of quarantine for close contact:
• Ab negative: Allow discharge
• Ab positive: Do PCR test to confirm
• Sample type: Blood (whole blood, serum or plasma)
• Used to detect convalescence phase / past infection
IgM/IgG Antibody Test
Antigen Test
PCR Test
• Malaysia is among the countries with the highest
number of COVID-19 testing among other ASEAN
nations
• Malaysia’s testing rate of 13 people per 1,000
population (as of 15th May 2020)
• Singapore: 25 tests per 1,000 population
Source: The Edge Markets, 15 May 2020
https://www.theedgemarkets.com/article/malaysia-among-asean-countries-performing-most-covid19-tests-%E2%80%94-health-dg
• Indonesia: 0.5 tests per 1,000 people

• United States’ testing rate is 16 people per 1,000 while the United
Kingdom’s is 10 per 1,000 population
Source: South China Morning Post, 28 April 2020
https://www.scmp.com/news/world/united-states-canada/article/3081819/coronavirus-latest-3-million-people-infected
Source: MOH Malaysia
Malaysia’s Daily COVID-19 Testing Capacity:

• March 18: 6,210 tests per day
• June 25: 36,812 tests per day
Testing is the key to defeating this pandemic!
Preanalytical Considerations
• All specimens must be considered potentially infectious
• Wear Personal Protection Equipment (PPE) while
processing samples:
• N95 mask or equivalent
• Eye Protection - face shield or goggles
• Disposable isolation gown (fluid-repellent longsleeved gown)
• Gloves
• Transportation of specimens to be within leak-proof
containers (triple layer packaging)
• Not recommended to use pneumatic transport systems
due to risk of aerosol release
• Within 5 to 6 days of the onset of symptoms, patients with
COVID-19 usually demonstrate high viral loads in their upper
and lower respiratory tracts
• Nasopharyngeal (NP) and/or Oropharyngeal (OP) swabs are
recommended for screening or diagnosis of early infection
• Flocked swabs feature perpendicular nylon fibers that optimize
specimen collection and elution into transport media (for PCR
samples)
• DO NOT use calcium alginate swabs or swabs with wooden
sticks as they may contain substances that inactivate some
viruses and inhibit PCR assays.
Source: Tang Y-W, Schmitz JE, Persing DH, Stratton CW. 2020. Laboratory diagnosis of COVID-19: current issues and challenges. J Clin
Microbiol 58:e00512-20.
Unlike Antibody RTK that uses blood samples from a
finger prick:
• Nasopharyngeal and/or oropharyngeal sampling need
to be performed by trained healthcare professionals
• This procedure potentially increased the risk of
transmission of the virus to healthcare workers
especially to those who lacked sufficient PPE
• Nasopharyngeal sampling is an invasive process that
can cause considerable distress to patient
• Poor sampling and inappropriate handling by
inexperienced staff might cause false negative results
• Ministry of Health Malaysia in collaboration with
hospitals and private medical service providers
launched home-based COVID-19 sampling services
• Allows those who wish to have the infection tested
but do not meet the criteria as a patient under
investigation (PUI) to get undergo testing
• Enable people with no symptoms to undergo
COVID-19 testing at home without having to
attend a health facility
• Home-based sampling service performed by
trained private medical practitioners and
paramedics
• Specimen sent to private laboratories for analysis
• Ease the presence of the public to conduct COVID-
19 testing in government hospitals and health
clinics
• Subject to charges imposed by the private service
providers
• Available for PCR testing only
• Ministry of Health Malaysia also provide drive-
thru screening services for COVID-19 testing at
selected health clinics in the country.
• Many private hospitals and laboratories in
Malaysia also offered drive-thru screening
services for COVID-19 testing
• Make COVID-19 testing more convenient and
easily available to the community
• Available for PCR testing only
Triple Layer Packaging
• First layer: Label Viral Transport Medium (for PCR
samples) or Swab Container (for Antigen RTK) with
patient’s name and ID, and ensure cap is properly
tighten before insert into a sealable biohazard bag
Source: Annex 5C Guidelines COVID-19 Management No.5/2020

Ministry of Health Malaysia
• Second layer: Put the VTM or Swab Container with
sealable biohazard bag into a clean, empty screw-
capped container
• Wipes the outer part with disinfectant
• Label the container with patient’s name and ID

• Third layer: Put container into styrofoam box with
ice pack to maintain temperature of 2-8°C
• Or alternatively specimen carrier bag or another
container

• Specimen should reach laboratory as soon as possible after collection
• Specimens that can be delivered promptly to the laboratory can be
stored at 2-8°C, or alternatively store at -80°C if transportation of
samples is more than 72 hours (only for PCR samples)
• For swab specimen of Antigen RTK, specimen should be tested within 4
hours after specimen is collected
• Samples to be processed in Class 2 Biological
Safety Cabinet (BSC Class II) as there is a risk
of spilling the specimen during the mixing
process
Analytical Considerations
• Selection of a suitable assay is very important as
laboratory testing is key to beating the COVID-
19 pandemic
• Immunoassays have been developed for rapid
detection of SARS-CoV-2 antigens or antibodies
• These rapid point-of-care immunoassays are
generally lateral flow assays for detecting
antigens or antibodies (IgM & IgG) against
COVID-19
• High-throughput immunoanalyzer assays are also
in development for population-level screening
• RTK provides advantage of a fast time to result
and low-cost but limited sensitivity especially in
early infection
• Given the variability of viral loads in COVID-19
patients, antigen detection may also miss cases
due to low infectious burden or sampling
variability
• IgM responses are nonspecific, and given the
weeks required to develop specific IgG responses,
serology detection is not likely to play a role in
active case management
• For geographically vast and resource-limited
countries, RTK testing especially Rapid Antibody
Testing is commonly being used
• Point-of-care testing: Rapid and on-site testing
• Processing of COVID-19 PCR / Ag samples require
specialised biocontainment laboratories (BSL2)
operated by highly trained laboratory personnel
• COVID-19 pandemic is pushing these testing
facilities to their capacity limit - sample backlog
and longer turnround time!
• Shortage of reagents, consumables
• A person tested Antibody (RTK) negative
needs to be re-tested again on Day 7
• A person tested Antibody (RTK) positive
needs to proceed with PCR testing as
confirmation
• 11 May 2020: Antibody RTK for COVID-19
or serological tests that use blood samples
from a finger prick cannot be used to
diagnose the disease - Director-General of
Health Malaysia, Datuk Dr Noor Hisham
Abdullah
Source: Director General of Health Malaysia’s letter to PERKESO dated 21 April 2020
• Presence of antibodies cannot confirm active
infection
• Negative antibody test result does not guarantee
that the tested individual is free of COVID-19
infection
• Can be used to conduct COVID-19 sero-prevalence
studies in the community or in targeted populations
• World Health Organization (WHO): Antibody RTK can
be used in surveillance activities and
epidemiological research
• No evidence so far that people who have recovered
from COVID-19 and produced antibodies are immune
or protected from a second infection
Source: WHO - "Immunity passports" in the context of COVID-19
https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19
Comparison of PCR vs Antigen RTK
Source: Science Valley Sdn Bhd (Distributor of SD Biosensor in Malaysia)

Rapid Antigen Testing in Malaysia
• 16 April 2020: Ministry of Health Malaysia
approved the use of Antigen RTK from South
Korea to help Malaysia boost its COVID-19
testing capacity
• The test kits undergone evaluation by IMR and
met the Ministry’s accuracy requirement with a
sensitivity rate of 84.4% and a specificity rate
of 100%
• First batch sent to Sabah and Sarawak to help
boost COVID-19 testing as the two states are
vast and the logistics are more challenging
Guideline on COVID-19 Testing Using Rapid Test
Kit (RTK-Ag) for Health Facilities, Ministry of
Health Version 2.0 (dated 22 May 2020):
• RTK-Ag has the advantage of detecting COVID-19
outbreaks quickly and in large quantities
• Since sample used is from NPS - an area with high
potential for viral content, sampling should be performed
by fully trained health personnel using appropriate PPE.
• Test should be conducted in the Biological Safety Cabinet
(BSC) Class II as there is a high risk of spilling the
specimen during the mixing process between the swab
and extraction buffer solution.
• The use of RTK-Ag is made priority in cases or samples that require urgent result for a
prompt patient management to be given.
• List of appropriate cases / samples as follows:
• Emergency and semi-emergency procedures or surgical cases with high probability of COVID-19
infection
• Brought in dead (BID) cases with high probability or high suspicion of COVID-19
• Screening for Severe Acute Respiratory Infection (SARI) and Influenza Like Illness (ILI)
• A wider coverage for screening in the area of Enforced Movement Control Order (EMCO)
• Screening under the order from Pegawai Kesihatan Daerah
• OKT (Orang Kena Tahan) to Depoh Tahanan Imigresen (DTI)
• PATI (Pendatang Asing Tanpa Izin) who is locked in prison cell less than 6 months and transfer to DTI
• Screening at the country’s entry point KLIA and KLIA2
• Government Servants who travel to Sarawak since 4 June 2020
Source: MOH Malaysia and Science Valley Sdn Bhd (Distributor of SD Biosensor in Malaysia)
• Importation and placement of a medical device in the Malaysian market requires
the device to comply with the requirements of the Medical Device Act 2012 (Act
737) and the medical device shall be registered with the Medical Device
Authority (MDA)
• Medical Device (Exemption) Order 2016 however has provided for exemption
from registration requirements of certain medical devices through special access if
they fulfill the criteria and submit a notification to the Authority
• This is to ensure the availability of medical devices in healthcare facilities, to
minimise a disruption of treatments during an emergency situation such as
during the COVID-19 pandemic period




SIMKA = Sistem Informasi Makmal Kesihatan Awam
Source: Guideline on COVID-19 Testing Using Rapid Test Kit (RTK-Ag) for Health Facilities, Ministry of Health Version 2.0 (dated 22 May 2020)
SIMKA = Sistem Informasi Makmal Kesihatan Awam
Source: Guideline on COVID-19 Testing Using Rapid Test Kit (RTK-Ag) for Health Facilities, Ministry of Health Version 2.0 (dated 22 May 2020)
COVID-19 RTK-Ag testing by team of Ministry of
Health Malaysia’s Medical Laboratory Technologists
at Kuala Lumpur International Airport (KLIA) and
klia2:
• 9 units of Biological Safety Cabinet (BSC) at KLIA
• 4 units of Biological Safety Cabinet (BSC) at klia2
• 2 operators each BSCs
Photo credit: En. Sanadi and MLT team at KLIA/klia2

Photo credit:
En. Sanadi and MLT team at KLIA/klia2
• Preanalytical and analytical challenges for COVID-19
Rapid Antigen Testing varies among different types of
laboratories
• For standalone laboratories:
• Unlike hospital lab, patient sampling is not conducted within
the same building or premise
• Nasopharyngeal swab must be properly packed in triple
packaging with ice pack to maintain temperature of 2-8°C
• Ensure specimen was brought back to the laboratory for
testing within 4 hours
• Numbers of Biological Safety Cabinet (BSC) Class II must be
sufficient to ensure testing for all samples received can be
done within the 4 hours period
• For on-site screening facilities e.g. KLIA:
• Numbers of Biological Safety Cabinet (BSC) Class II
must be sufficient to ensure testing for big batch of
samples can be performed fast enough to avoid
long queue (social distancing)
• Ensure sufficient number of laboratory personnel
to carry out the testing in a timely manner
(preferably 2 operators each BSC)
Thank you for listening!
Terima kasih!
Any enquiries, please email to:
kianshing1228@gmail.com

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TAN KIAN SHING, MIMLS (Mal)

B.Sc (Hons) Biotechnology

Advancing Excellence In Healthcare Testing

COVID-19 Triple Gene Real-Time RT-PCR

COVID-19 Antigen Test

Advancing Excellence In Healthcare Testing

• Indonesia: 0.5 tests per 1,000 people

Malaysia’s Daily COVID-19 Testing Capacity:

Source: Annex 5C Guidelines COVID-19 Management No.5/2020

Source: Annex 5C Guidelines COVID-19 Management No.5/2020

Source: Annex 5C Guidelines COVID-19 Management No.5/2020

Source: Science Valley Sdn Bhd (Distributor of SD Biosensor in Malaysia)

Source: Science Valley Sdn Bhd (Distributor of SD Biosensor in Malaysia)

Source: Science Valley Sdn Bhd (Distributor of SD Biosensor in Malaysia)

Source: Science Valley Sdn Bhd (Distributor of SD Biosensor in Malaysia)

Source: Science Valley Sdn Bhd (Distributor of SD Biosensor in Malaysia)

SIMKA = Sistem Informasi Makmal Kesihatan Awam

SIMKA = Sistem Informasi Makmal Kesihatan Awam

Photo credit: En. Sanadi and MLT team at KLIA/klia2

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