Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigen

<p><strong>Objectives:</strong> Two rapid tests, <em>CORTEZ’S HBsAg one step</em> and <em>CTK Biotech’s Onsite HBsAg, </em>for the detection of HBsAg in the serum were compared using the SURASE B-96 (TMB) enzyme immunoassay (EIA) as the comparator.</p>...

Full description

Bibliographic Details
Main Authors: EWS Chameera, F Noordeen, H Pandithasundara, AMSB Abeykoon
Format: Article
Language:English
Published: Sri Lankan Society for Microbiology 2013-07-01
Series:Sri Lankan Journal of Infectious Diseases
Subjects:
Online Access:https://sljid.sljol.info/articles/5172
_version_ 1828332873610952704
author EWS Chameera
F Noordeen
H Pandithasundara
AMSB Abeykoon
author_facet EWS Chameera
F Noordeen
H Pandithasundara
AMSB Abeykoon
author_sort EWS Chameera
collection DOAJ
description <p><strong>Objectives:</strong> Two rapid tests, <em>CORTEZ’S HBsAg one step</em> and <em>CTK Biotech’s Onsite HBsAg, </em>for the detection of HBsAg in the serum were compared using the SURASE B-96 (TMB) enzyme immunoassay (EIA) as the comparator.</p><p><strong>Methods:</strong> Fifty blood samples (n=50) were tested using the two rapid tests and the EIA.</p><p><strong></strong><strong>Results:</strong> Based on the EIA, 5 sera were positive for HBsAg and 45 sera were negative for HBsAg. However, 4 sera were positive while 46 sera were negative for HBsAg when tested by Biotech’s Onsite HBsAg. Three (n=3) sera were positive while 47 sera were negative for HBsAg when tested by CORTEZ’S HBsAg one step detection kit. The specificity and the positive predictive value (PPV) were 100% for both rapid tests. However, the sensitivity and negative predictive value (NPV) for Biotech’s Onsite HBsAg assay and CORTEZ’S HBsAg one step assay were 80% and 97.82% and 60% and 95.74%, respectively.</p><p><strong></strong><strong>Conclusions:</strong> Both rapid tests showed less sensitivity and NPV than the EIA. Sensitivity and NPV were higher with <em>Onsite HBsAg</em> than the <em>CORTEZ’S HBsAg</em> making the former slightly better than the latter for detecting serum HBsAg. According to our findings, the accuracy of rapid tests for HBsAg detection varied compared to EIA, suggesting the importance of validating rapid tests routinely when used in diagnostic laboratories.</p><p class="Default">DOI: <a href="http://dx.doi.org/10.4038/sljid.v3i2.5172">http://dx.doi.org/10.4038/sljid.v3i2.5172</a></p> <p class="Default"><em>Sri Lankan Journal of Infectious Diseases 2013; Vol.3(2):21-27</em></p>
first_indexed 2024-04-13T21:13:11Z
format Article
id doaj.art-45f34b73d243477fac3a71c190f353e3
institution Directory Open Access Journal
issn 2012-8169
2448-9654
language English
last_indexed 2024-04-13T21:13:11Z
publishDate 2013-07-01
publisher Sri Lankan Society for Microbiology
record_format Article
series Sri Lankan Journal of Infectious Diseases
spelling doaj.art-45f34b73d243477fac3a71c190f353e32022-12-22T02:29:47ZengSri Lankan Society for MicrobiologySri Lankan Journal of Infectious Diseases2012-81692448-96542013-07-0132212710.4038/sljid.v3i2.51724625Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigenEWS Chameera0F Noordeen1H Pandithasundara2AMSB Abeykoon3Faculty of Medicine, University of Peradeniya.Faculty of Medicine, University of PeradeniyaFaculty of Medicine, University of PeradeniyaFaculty of Medicine, University of Peradeniya<p><strong>Objectives:</strong> Two rapid tests, <em>CORTEZ’S HBsAg one step</em> and <em>CTK Biotech’s Onsite HBsAg, </em>for the detection of HBsAg in the serum were compared using the SURASE B-96 (TMB) enzyme immunoassay (EIA) as the comparator.</p><p><strong>Methods:</strong> Fifty blood samples (n=50) were tested using the two rapid tests and the EIA.</p><p><strong></strong><strong>Results:</strong> Based on the EIA, 5 sera were positive for HBsAg and 45 sera were negative for HBsAg. However, 4 sera were positive while 46 sera were negative for HBsAg when tested by Biotech’s Onsite HBsAg. Three (n=3) sera were positive while 47 sera were negative for HBsAg when tested by CORTEZ’S HBsAg one step detection kit. The specificity and the positive predictive value (PPV) were 100% for both rapid tests. However, the sensitivity and negative predictive value (NPV) for Biotech’s Onsite HBsAg assay and CORTEZ’S HBsAg one step assay were 80% and 97.82% and 60% and 95.74%, respectively.</p><p><strong></strong><strong>Conclusions:</strong> Both rapid tests showed less sensitivity and NPV than the EIA. Sensitivity and NPV were higher with <em>Onsite HBsAg</em> than the <em>CORTEZ’S HBsAg</em> making the former slightly better than the latter for detecting serum HBsAg. According to our findings, the accuracy of rapid tests for HBsAg detection varied compared to EIA, suggesting the importance of validating rapid tests routinely when used in diagnostic laboratories.</p><p class="Default">DOI: <a href="http://dx.doi.org/10.4038/sljid.v3i2.5172">http://dx.doi.org/10.4038/sljid.v3i2.5172</a></p> <p class="Default"><em>Sri Lankan Journal of Infectious Diseases 2013; Vol.3(2):21-27</em></p>https://sljid.sljol.info/articles/5172rapid immunochromatography assayshepatitis b virusserum hbsagenzyme immunoassays
spellingShingle EWS Chameera
F Noordeen
H Pandithasundara
AMSB Abeykoon
Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigen
Sri Lankan Journal of Infectious Diseases
rapid immunochromatography assays
hepatitis b virus
serum hbsag
enzyme immunoassays
title Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigen
title_full Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigen
title_fullStr Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigen
title_full_unstemmed Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigen
title_short Diagnostic efficacy of rapid assays used for the detection of hepatitis B virus surface antigen
title_sort diagnostic efficacy of rapid assays used for the detection of hepatitis b virus surface antigen
topic rapid immunochromatography assays
hepatitis b virus
serum hbsag
enzyme immunoassays
url https://sljid.sljol.info/articles/5172
work_keys_str_mv AT ewschameera diagnosticefficacyofrapidassaysusedforthedetectionofhepatitisbvirussurfaceantigen
AT fnoordeen diagnosticefficacyofrapidassaysusedforthedetectionofhepatitisbvirussurfaceantigen
AT hpandithasundara diagnosticefficacyofrapidassaysusedforthedetectionofhepatitisbvirussurfaceantigen
AT amsbabeykoon diagnosticefficacyofrapidassaysusedforthedetectionofhepatitisbvirussurfaceantigen