Comparison of Two Test Strategies for Clarification of Reactive Results for Anti-HBc in Blood Donors
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Comparison of Two Test Strategies for Clarification of Reactive Results for Anti-HBc in Blood Donors. / Juhl, David; Knobloch, Johannes K-M; Görg, Siegfried; Hennig, Holger.
in: TRANSFUS MED HEMOTH, Jahrgang 43, Nr. 1, 01.2016, S. 37-43.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Comparison of Two Test Strategies for Clarification of Reactive Results for Anti-HBc in Blood Donors
AU - Juhl, David
AU - Knobloch, Johannes K-M
AU - Görg, Siegfried
AU - Hennig, Holger
PY - 2016/1
Y1 - 2016/1
N2 - OBJECTIVE: Testing for antibodies against hepatitis B core antigen (anti-HBc) was introduced to detect blood donors suffering from occult hepatitis B infection. Confirmation of specification of reactive results in the anti-HBc screening assay is still a challenge for blood donation services.METHODS: Two different test strategies for confirmation of specification of reactive anti-HBc tests, one performed in our institute and one suggested by the German authority (Paul-Ehrlich-Institut (PEI)), were compared. The first strategy is based on one supplemental anti-HBc test, the other requires two supplemental anti-HBc tests.RESULTS: 389 samples from 242 donors were considered. Both test strategies yielded concordant results in 117 reactive samples termed 'true-positive' or 'specificity confirmed', in 156 reactive samples termed 'false-positive' or 'specificity not confirmed', and in 99 negative samples. In 17 samples obtained from 11 donors, both test strategies gave discrepant results ('false-positive' but 'specificity confirmed'). In 10 of 11 donors, a real HBV infection was very unlikely, one remained unclear. 30 donors considered 'false-positive' became negative in all anti-HBc tests after follow-up testing and thus eligible for donor re-entry.CONCLUSIONS: The test strategy suggested by the PEI yielded no additional information but induced an overestimation of HBV infections and unnecessary look-back procedures. Many anti-HBc-reactive donors can be regained after follow-up testing.
AB - OBJECTIVE: Testing for antibodies against hepatitis B core antigen (anti-HBc) was introduced to detect blood donors suffering from occult hepatitis B infection. Confirmation of specification of reactive results in the anti-HBc screening assay is still a challenge for blood donation services.METHODS: Two different test strategies for confirmation of specification of reactive anti-HBc tests, one performed in our institute and one suggested by the German authority (Paul-Ehrlich-Institut (PEI)), were compared. The first strategy is based on one supplemental anti-HBc test, the other requires two supplemental anti-HBc tests.RESULTS: 389 samples from 242 donors were considered. Both test strategies yielded concordant results in 117 reactive samples termed 'true-positive' or 'specificity confirmed', in 156 reactive samples termed 'false-positive' or 'specificity not confirmed', and in 99 negative samples. In 17 samples obtained from 11 donors, both test strategies gave discrepant results ('false-positive' but 'specificity confirmed'). In 10 of 11 donors, a real HBV infection was very unlikely, one remained unclear. 30 donors considered 'false-positive' became negative in all anti-HBc tests after follow-up testing and thus eligible for donor re-entry.CONCLUSIONS: The test strategy suggested by the PEI yielded no additional information but induced an overestimation of HBV infections and unnecessary look-back procedures. Many anti-HBc-reactive donors can be regained after follow-up testing.
KW - Journal Article
U2 - 10.1159/000441676
DO - 10.1159/000441676
M3 - SCORING: Journal article
C2 - 27022321
VL - 43
SP - 37
EP - 43
JO - TRANSFUS MED HEMOTH
JF - TRANSFUS MED HEMOTH
SN - 1660-3796
IS - 1
ER -