TY - JOUR
T1 - Cutoff Value of Qualitative HBsAg for Confirmatory HBsAg Using the Chemiluminescence Microparticle Immunoassay Method
AU - Pasaribu, Merci Monica
AU - Wonohutomo, Jessica Purwanti
AU - Immanuel, Suzanna
AU - Kumalawati, July
AU - Indrasari, Nuri Dyah
AU - Yusra, Yusra
N1 - Publisher 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: [email protected].
PY - 2022/9/1
Y1 - 2022/9/1
N2 - BACKGROUND: Confirmatory hepatitis B surface antigen (HBsAg) is an assay used to distinguish weakly reactive from false-positive HBsAg results. 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: 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: 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: 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.
AB - BACKGROUND: Confirmatory hepatitis B surface antigen (HBsAg) is an assay used to distinguish weakly reactive from false-positive HBsAg results. 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: 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: 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: 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.
KW - CMIA
KW - false positive
KW - HBsAg Qualitative II
KW - HBsAg Qualitative II Confirmatory
KW - hepatitis B
KW - S/CO value
UR - http://www.scopus.com/inward/record.url?scp=85137138165&partnerID=8YFLogxK
U2 - 10.1093/labmed/lmac021
DO - 10.1093/labmed/lmac021
M3 - Article
C2 - 35394549
AN - SCOPUS:85137138165
SN - 0007-5027
VL - 53
SP - 475
EP - 478
JO - Laboratory Medicine
JF - Laboratory Medicine
IS - 5
ER -
