NAT Proficiency Study Program in Japan

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NAT Proficiency Study Program in Japan
Saeko Mizusawa, Yoshiaki Okada National Institute
of Infectious Diseases, Japan
SoGAT XXI In Brussels, Belgium 28-29 May 2009
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Background

• National Standards for NAT Calibrated against WHO
  IS
• HCV(1999 ), HBV(2002 ), HIV(2002)

• Guideline for Industry on NAT 2004
• HCV, HBV, HIV
• Validated method with 100 IU/ml (95DL)

• Guideline for Look Back Study 2005
• HCV core antigen
• HBV NAT
• HIV antibody

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Objectives

• To assess the proficiency and sensitivity of the
  validated routine NAT implemented in plasma pool
  and blood screening.

To assess the performance of diagnostic HBV-NAT
to test recipients according to Look-back
guideline. To chose the suitable HBV-NAT kits if
necessary.
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Materials and Methods
Panels Prepared by NIID by diluting the
respective national Standard. Each panel
consists of 8 coded samples, 7 positive and one
negative samples. AssayThree independent
assays on different days with validated routine
NAT methods Data Reported positive or
negative for qualitative assays and
concentration for quantitative assays.The
presented data were analyzed by NIID.
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The 1st NAT Control Surveillance 2006HBV-NAT
Participants
Organization Location No. of Organizations No. of Laboratories
Blood Product Manufacturer blood center Japan 4 6
Blood Product Manufacturer blood center US/EU 3 4
Diagnostic Laboratory Japan 7 7
Kit Manufacturer Japan 2 3
OCL Japan 1 1
Total Total 17 21

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NAT Control Surveillance 2006HBV-NAT Methods
Assay Number of Assay Sets Number of Assay Sets Number of Assay Sets Number of Assay Sets Number of Assay Sets
Assay Manufact. blood c. OCL Diagnostic Lab Kit maker Total
Qualitative
AmpliScreen 6 1 1 8
Monitor 1 1 2
In-house (5 kinds) 7 2 9
TMA 1 1
Total 15 1 4 20
Quantitative Diagnostic kit
Kit A 7 1 8
Kit B 3 1 4
Total 10 2 12
Overall 15 1 10 6 31
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HBV-NAT Control Surveillance 2006(1) Assays
Required by NAT-Guideline
8
HBV-NAT Control Surveillance 2006(2) Assays
Recommended by Guideline for Look-back
Study
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The 2nd NAT Control Surveillance 2007HCV-NAT
HIV-NAT Participants
Organization Location HCV-NAT HCV-NAT HIV-NAT HIV-NAT
Organization Location Org Lab Org Lab
Blood Product Manufacturer blood center Japan 4 6 4 6
Blood Product Manufacturer blood center US/EU 2 3 2 3
Diagnostic Lab Japan 7 7 3 3
Kit Manufacturer Japan 1 1 1 1
OCL Japan 1 1 1 1
Total Total 15 18 11 14
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HCV-NAT Control Surveillance 2007Methods
(Qualitative)
Assay Number of Assay Sets Number of Assay Sets Number of Assay Sets Number of Assay Sets Number of Assay Sets
Assay Manufact. Blood C. OCL Diagnostic Lab Kit maker Total
AmpliScreen 4 1 1 6
TaqScreen MPX 1 1
TMA Assay 1 1
In-house (4 kinds) 6 1 7
Total 12 1 2 15
Amplicap/Amplicor 4 1 5
COBAS Amplicor 2 2
TMA Assay 1 1
Total 7 1 8
Overall 12 1 7 3 23
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HCV-NAT Control Surveillance 2007
44/45
45/45
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HIV-NAT Assay Methods
Assay Number of Assay Sets Number of Assay Sets Number of Assay Sets Number of Assay Sets Number of Assay Sets
Assay Manufacture Blood c. OCL Diagnostic Lab Kit maker Total
Qualitative
AmpliScreen 4 1 1 6
TaqScreen 1 1
TMA 1 1
In-house (4 kinds) 6 1 7
?? 12 1 2 15
Quantitative
Monitor 2 1 3
Monitor Standard 1 1 2
?? 3 2 5
?? 12 1 3 4 20
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HIV-NAT Control Surveillance2007
44/45
37/45
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Summary (1) NAT for Plasma Pool and Blood
Screening

1. All the samples containing 1000 IU/ml virus or
   more were detectable HBV in 60/60, HCV in 45/45,
   HIV in 45/45.No false positive results were
   observed.
2. Samples containing 300 IU/ml, which is three
   times the 95DL , were positive for HBV in 60/60
   (100), for HCV in 45/45 (100), for HIV in
   44/45 (98). The laboratory which failed to
   detect 1/3 of 300 IU/ml of HIV samples was able
   to detect 100 IU/ml in 2/3.
3. Samples containing 100 IU/ml (95DL) were
   positive for HBV in 60/60 (100), for HCV in
   44/45 (98), for HIV in 37/45 (82).
4. Overall, the qualities of NAT, proficiency and
   the sensitivity , were satisfactory .

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Summary (2) NAT for Look-back Study

• Two quantitative HBV-DNA kits were available (Kit
  A and B).No false positive results were observed
  in both kit A and kit B.
• Kit A was able to measure all the positive
  samples (10 10000 IU/ml) while kit B was able
  to measure samples containing 3000 IU/ml or
  more.

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Summary (3)

• NAT control surveillance should be continued
• To reflect the results on regulations.
• To improve the performance of participants
• To confirm that routine NAT is able to detect all
  the genotypes/subtypes.
• To assess performance of newly developed assay
  systems.

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Collaboration with
Department of Bacteriology II, NIID Yoshinobu
Horiuchi Department of Blood and Safety
Research, NIID Toshiaki Mizuochi Kazunari
Yamaguchi
Working Group on NAT Control Surveillance Chaired
by Dr. Teruhide Yamaguchi National Institute of
Health Sciences