Diagnostic Test at MRL

  • Hepatitis A Antibodies (Total)
  • Hepatitis B surface Antigen
  • Hepatitis B surface Antibodies
  • Hepatitis B e Antigen
  • Hepatitis B e Antibodies
  • Hepatitis C Antibodies

Molecular Tests

  • Hepatitis B DNA Real-Time PCR, Quantitative
  • Hepatitis B Drug Resistance
  • Hepatitis B Genotyping
  • Hepatitis C RNA Real Time PCR, Qualitative
  • Hepatitis C RNA Real Time PCR, Quantitative
  • Hepatitis C Genotyping
  • HIV-1 RNA Real Time PCR, Quantitative

Hepatitis Serology

Molecular Diagnostic Test

Tests

Hepatitis B DNA Quantitative


Hepatitis C RNA Quantitative


Hepatitis C RNA Qualitative


HIV-1 RNA Quantitative


Hepatitis B Drug Resistance






Hepatitis B Genotyping


Hepatitis C Genotyping

 

Method

Real Time PCR


Real Time PCR


Real Time PCR


Real Time PCR


Line-probe assay





Line-probe assay

Line-probe assay

Kit

COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0


COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, v2.0

COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative Test, v2.0

COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0


Fujirebio INNO-LIPA® HBV MULTI-DR






Fujirebio INNO-LiPA HBV Genotyping (HBV DNA Polymerase Domain B & C)

VERSANT HCV Genotype 2.0 Assay (LiPA)
(5’ non-coding region and core region)

 

Detection Limit

20 IU/ml – 170,000,000 IU/m

15 IU/ml – 100,000,000 IU/ml

15 IU/ml


20 copies/ml – 10,000,000 copies/ml

wild-type motif, lamivudine, telbivudine, emtricitabine, adefovir, and entecavir resistance-associated mutations.

Genotypes A to H


Genotype 1 to 6 Common subtypes

Breakdown Number of Diagnostic Test (2000 - September 2015)

Breakdown of Molecular Diagnostic Test (2000 - September 2015)

% Breakdown of Molecular Diagnostic (2000 - September 2015)

The MRL top 10 clients 2014

No.

1

2

3

4

5

6

7

8

9

10

Clients

Island Hospital

Sime Darby Medical Centre Subang Jaya

Penang Adventist Hospital

Sunway Medical Specialist Hospital

KPJ Johor Specialist Hospital

Lam Wah Ee Hospital

Gleneagles Penang

Prince Court Medical Centre

Low Gastro & Medical Clinic, J. Bahru

Loh Guan Lye Specialist Centre

Request (N-4322)

662

491

352

331

242

221

154

129

113

109

2804

% Request

15.32

11.36

8.14

7.66

5.60

5.11

3.56

2.98

2.61

2.52

64.88

Tests sponsored by pharmaceuticals companies:

Sponsor

Test

Quantity - 2013

Duration

Roche Malaysia

HCV RNA Quantitative

HCV RNA Qualitative

HCV Genotyping

HBV DNA Quantitative

HBV Genotyping

HBV Drug Resistance

500

331

212

50

1

1

Nov 2005 – on going
(1095 tests sponsored)

DKSH

HBV DNA Quantitative

76

Oct 2006 – on going
(76 tests sponsored)

MSD

HCV RNA Quantitative

HCV RNA Qualitative

HCV Genotyping

HBV DNA Quantitative

271

107

117

1

Dec 2007 – on going
(496 tests sponsored)

Roche Diagnostics & DKSH

HBsAg

HCV-Ab

467

127

World Hepatitis Day 2013, Selayang Hospital

PROFICIENCY TESTING

The Molecular Research Laboratory is currently enrolled with the:

  • Royal College for Pathologist Australia for Hepatitis Serology and Molecular Diagnostics (HBV, HCV and HIV) proficiency testing (RCPA)
  • Quality Control for Molecular Diagnostics (QCMD), Scotland for the HBV, HCV and HIV Proficiency programmes
  • Accutest, US for Hepatitis C Genotyping proficiency testing
  • Internal QC samples

The overall achievement for the external proficiency testing for the year 2013 was 96%.

External Quality Proficiency Test

EQA

Royal College for Pathologies
Australia (RCPA)

Quality Control for Molecular
Diagnostics (QCMD), Scotland

OneWorld Accuracy, US

2001 to 2004

Hepatitis Serology

HBV DNA

HCV RNA

HIV-1 RNA

HCV Genotyping

2005

Hepatitis Serology

HBV DNA

HCV RNA

HIV-1 RNA

HCV Genotyping

HCV Genotyping

2006

Hepatitis Serology

HBV DNA

HCV RNA

HIV-1 RNA

HCV Genotyping

HBV Genotyping

HCV Genotyping

2007 to 2012

Hepatitis Serology

HBV DNA

HCV RNA

HIV-1 RNA

HCV Genotyping

HBV DNA

HCV RNA

HIV-1 RNA

HCV Genotyping

HBV Genotyping

HCV Genotyping

2013 to 2015

Hepatitis Serology

HBV DNA

HCV RNA

HIV-1 RNA

HCV Genotyping

HBV DNA

HCV RNA

HIV-1 RNA

HCV Genotyping

HBV Genotyping

HBV Drug Resistance (New)

HCV Genotyping

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