Cutoff Value of Qualitative HBsAg for Confirmatory HBsAg Using the Chemiluminescence Microparticle Immunoassay Method.
CMIA
HBsAg Qualitative II
HBsAg Qualitative II Confirmatory
S/CO value
false positive
hepatitis B
Journal
Laboratory medicine
ISSN: 1943-7730
Titre abrégé: Lab Med
Pays: England
ID NLM: 0250641
Informations de publication
Date de publication:
01 Sep 2022
01 Sep 2022
Historique:
pubmed:
9
4
2022
medline:
8
9
2022
entrez:
8
4
2022
Statut:
ppublish
Résumé
Confirmatory hepatitis B surface antigen (HBsAg) is an assay used to distinguish weakly reactive from false-positive HBsAg results. To determine the signal to cutoff (S/CO) value of chemiluminescence microparticle immunoassay (CMIA) HBsAg assay that should trigger follow-up confirmatory HBsAg testing. All specimens with an initial S/CO value of 0.90-100.00 were subjected to repeat HBsAg testing after high-speed centrifugation. The specimens with an initial S/CO value in that range remained in the same range and were then followed up with confirmatory HBsAg testing. In total, 132 specimens had an S/CO value between 0.90 and 100.00 after high-speed centrifugation, followed by confirmatory HBsAg retesting. The S/CO value of HBsAg specimens for which the results required verification with confirmatory HBsAg was 0.98 (100% sensitivity, 3.3% specificity) through 9.32 (47.1% sensitivity, 100% specificity). The HBsAg S/CO values (as determined by the chemiluminescent microparticle immunoassay [CMIA] method) that should trigger confirmatory HBsAg testing are 0.98-9.32.
Sections du résumé
BACKGROUND
BACKGROUND
Confirmatory hepatitis B surface antigen (HBsAg) is an assay used to distinguish weakly reactive from false-positive HBsAg results.
OBJECTIVE
OBJECTIVE
To determine the signal to cutoff (S/CO) value of chemiluminescence microparticle immunoassay (CMIA) HBsAg assay that should trigger follow-up confirmatory HBsAg testing.
METHODS
METHODS
All specimens with an initial S/CO value of 0.90-100.00 were subjected to repeat HBsAg testing after high-speed centrifugation. The specimens with an initial S/CO value in that range remained in the same range and were then followed up with confirmatory HBsAg testing.
RESULT
RESULTS
In total, 132 specimens had an S/CO value between 0.90 and 100.00 after high-speed centrifugation, followed by confirmatory HBsAg retesting. The S/CO value of HBsAg specimens for which the results required verification with confirmatory HBsAg was 0.98 (100% sensitivity, 3.3% specificity) through 9.32 (47.1% sensitivity, 100% specificity).
CONCLUSION
CONCLUSIONS
The HBsAg S/CO values (as determined by the chemiluminescent microparticle immunoassay [CMIA] method) that should trigger confirmatory HBsAg testing are 0.98-9.32.
Identifiants
pubmed: 35394549
pii: 6565498
doi: 10.1093/labmed/lmac021
doi:
Substances chimiques
Hepatitis B Surface Antigens
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
475-478Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.