The effect of NAT sensitivity on the yield of HBV DNA, HCV RNA and HIV RNA detection in seronegative donations

1
The effect of NAT sensitivity on the yield of
HBV DNA, HCV RNA and HIV RNA detection in
seronegative donations

• Ewa Brojer, Grzegorz Liszewski, Aneta Kopacz,
• Piotr Grabarczyk, Magdalena Letowska and Polish
  Blood Transfusion Service Viral Study Group
• Institute of Haematology and Transfusion
  Medicine, Warsaw, Poland

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NAT screening systems - Poland1 million
donation/year
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The aim of the study

• to compare the analytical and clinical
  sensitivity of three NAT screening systems
• Cobas Ampliscreen - in pools of 24
• Cobas S201 - in pools of 6
• Procleix Ultrio (Tigris) - IDT
• for detection of window period of HIV, HCV and
  HBV infection and occult HBV infection

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Material and methods

• 1 595 534 donations - screened by Cobas
  Ampliscreen in pools of 24
• 632 670 donations - by Cobas 201 in pools of
  6
• 1 439 221 single donations - screened by Procleix
  TMA
• 238 971 screened by Procleix HCV/HIV-1 TMA
• 1 151 652 - screened by Procleix Ultrio TMA
• The sensitivity of methods was tested using WHO
  HCV 96/790, 96/798 WHO HIV-1 97/650 WHO HBV
  97/746 standards.

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Analitical sensitivity of NAT assays
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. The yield of HCV RNA, HBV DNA and HIV RNA in
seronegative blood donors
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Conclusions

• The yield of HCV RNA is not influenced by the
  sensitivity of the NAT
• The yield of HBV window period and occult is
  highly influenced by the sensitivity of the test
• The screening using Cobas s201 in pools of 6 and
  Procleix Ultrio TMA in single donations give
  similar yield of both window period and occult
  HBV infection,
• The frequency of HIV window period donations is
  to low for conclusion