SoGAT meeting XXI May (2009), Brussels, Belgium

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Presentation transcript:

SoGAT meeting XXI May 28-29 (2009), Brussels, Belgium Comparison of HBV NAT in small versus large test pools experience with the S 201 system SoGAT meeting XXI May 28-29 (2009), Brussels, Belgium Marco Koppelman1,3,Theo Cuypers2, Harry Bos3 and Hans Zaaijer1 Sanquin Diagnostics, Amsterdam, the Netherlands 1. Blood-borne Infections (BOI) 2. Viral Diagnostic Services 3. National Screening Laboratory Sanquin (NSS) 25 April 2019

NAT yield cases (HBsAg (-)/HBV-DNA (+) of two testing formats In the Netherlands no anti-HBc screening in the past Number of HBV infections in donors in the Netherlands is low: 2007; 4 cases in repeat donors and 25 cases in new donors Large test pools (July 2006 - October 2008) - HBV NAT in test pools of 480 donations - AmpliScreen test for HBV DNA (Roche) - 2,066,283 donations tested Small test pools (November 2008- May 2009) - HBV NAT in pools of 6 donations - MPX test on the S 201 system (Roche) - 458,365 donations tested Archive sample of previous donations allow look-back to previous donations 25 April 2019

Sensitivity of both test formats Type of screening Test Sensitivity for individual donation2 Pools of 480 Plasma1 HBV AmpliScreen 2,400 IU/ml Pools of 6 Donor MPX on S 201 26 IU/ml 1For release of plasma for manufacturing 2Determined by Sanquin based on dilution series of the HBV DNA WHO IS Testing pools of 6 is approximately 100 times more sensitive than testing pools of 480 25 April 2019

NAT only donations pool 480 format 2 cases HBV DNA (+)/ HBsAg (-) donations both repeat donors 25 April 2019

Pools of 480 format: donor 1 Date donation HBsAg HBV DNA Anti-HBc Anti-HBs (IU/L) 07-2007 NEG nt 09-2007 10-2007 POS (<2,000 IU/ml) POS (241) 11-2007 POS POS (250) Donor was vaccinated for HBV in the past Probably a recent HBV infection (HBV gt A) Anti-HBs of previous vaccination not detectable Due to boostering effect, anti-HBs detectable in early phase of infection 25 April 2019

Pools of 480 format: donor 2 Date donation HBsAg HBV DNA Anti-HBc Anti-HBs 11-2005 NEG nt 05-2007 POS (288 IU/ml) 06-2007 POS 11-2007 Recent HBV infection HBV genotype G Lower HBsAg production Associated with HBV genotype A? (14 clones tested: genotype G only)1 1Chudy et all (2006) Hepatology 44:99-107 25 April 2019

NAT only donations pools 6 format 5 cases HBV DNA (+)/ HBsAg (-) donations All repeat donors One donation during WP of HBV infection (donor 1) Index donation: no serological markers for HBV infection HBV DNA load: 21,115 IU/ml Four occult HBV infections (donors 2, 3, 4, and 5) 25 April 2019

Donor 2 Date donation HBsAg HBV DNA Anti-HBc Anti-HBs (IU/L) 10-1996 NEG nt POS POS (177) 03-2007 06-2008 10-2008 02-2009 POS (31) POS (78) nt= not tested - Low HBV DNA loads (<12 IU/ml) - Index and counseling: HBeAg (-); anti-HBe (-); anti-HBc-IgM (-) 25 April 2019

Donor 3 Date donation HBsAg HBV DNA Anti-HBc Anti-HBs 11-2008 NEG POS 03-2009 nt= not tested - Low HBV DNA loads (approx. 200 IU/ml) - Counseling: HBeAg (-); anti-HBe (-); anti-HBc-IgM (-) - Previous donations possibly implicated in post transfusion HBV infection (under investigation) 25 April 2019

Donor 4 Date donation HBsAg HBV DNA Anti-HBc Anti-HBs 06-2007 NEG POS 09-2008 12-2008 03-2009 04-2009 nt= not tested - Low HBV DNA loads (<12 IU/ml) - Index and counseling: HBeAg (-); anti-HBe (-); anti-HBc-IgM (-) 25 April 2019

Donor 5 Date donation HBsAg HBV DNA Anti-HBc Anti-HBs pending 05-2009 NEG POS (<12 IU/ml) POS POS (86) - Low HBV DNA loads (<12 IU/ml) - Index: HBeAg (-); anti-HBe (-); anti-HBc-IgM (-) 25 April 2019

HBV NAT Yield Test format Sensitivity for individual donation # donations tested NAT Yield NAT only frequency Pools of 480 2,400 IU/ml 2,066,283 2 1,033,142 Pools of 6 26 IU/ml 458,365 5 91,673 25 April 2019

Summary/Conclusion HBV NAT in small test pools has been introduced successfully in the Netherlands (MPX on S 201 system) with good performance Detection of HBV NAT only donations increased 10x due to increased sensitivity (100x) Major benefit of introduction of HBV NAT until now is detection of occult cases. This relatively high number of occult cases in a low endemic country is due to the fact that the donor population has not been tested for anti-HBc 25 April 2019