Jasmine Samal, Anushka Soni, Amit Pandey, Gagan Chooramani, Ekta Gupta
{"title":"用于检测临床样本中乙型肝炎表面抗原的 Determine HBsAg 2 快速检测卡性能评估。","authors":"Jasmine Samal, Anushka Soni, Amit Pandey, Gagan Chooramani, Ekta Gupta","doi":"10.5005/jp-journals-10018-1403","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim and background: </strong>Hepatitis B virus is one of the leading underlying causes of chronic liver disease. Rapid diagnostic tests with improved sensitivity and specificity for detecting hepatitis B infection could aid in large-scale community screening in resource-limited settings. This study was designed to assess the clinical performance of a rapid card test to detect HBsAg.</p><p><strong>Materials and methods: </strong>In this study, archived once-thawed serum samples were tested on the Determine HBsAg 2 card and their performance was evaluated in reference to a chemiluminescence-based assay (HBsAg qualitative assay, Abbott Diagnostics, US).</p><p><strong>Results: </strong>A total of 120 patient samples (46 confirmed HBsAg-positive and 74 confirmed HBsAg-negative) were used in this study. The overall median age of the study population was 44 years (IQR: 36-51 years), with a male gender predominance (90%). A specificity of 100% (74/74) and sensitivity of 84.7% (39/46) was observed for the Determine HBsAg 2 assay compared with the reference assay. The samples that showed false-negative results (<i>n</i> = 7) by the card test had HBsAg levels below the limit-of-detection of the card assay.</p><p><strong>Conclusion: </strong>The Determine HBsAg 2 assay gives rapid results in 15 minutes with good sensitivity and specificity. This makes it a good, affordable tool for large-scale screening and public health surveillance programs.</p><p><strong>Clinical significance: </strong>Accurate and cost-effective rapid card tests for early detection of Hepatitis B infection would enable quick isolation of infected cases, thus reducing transmission in the community.</p><p><strong>How to cite this article: </strong>Samal J, Soni A, Pandey A, <i>et al</i>. Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples. Euroasian J Hepato-Gastroenterol 2024;14(1):9-11.</p>","PeriodicalId":516317,"journal":{"name":"Euroasian journal of hepato-gastroenterology","volume":"14 1","pages":"9-11"},"PeriodicalIF":0.0000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11249907/pdf/","citationCount":"0","resultStr":"{\"title\":\"Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples.\",\"authors\":\"Jasmine Samal, Anushka Soni, Amit Pandey, Gagan Chooramani, Ekta Gupta\",\"doi\":\"10.5005/jp-journals-10018-1403\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim and background: </strong>Hepatitis B virus is one of the leading underlying causes of chronic liver disease. Rapid diagnostic tests with improved sensitivity and specificity for detecting hepatitis B infection could aid in large-scale community screening in resource-limited settings. This study was designed to assess the clinical performance of a rapid card test to detect HBsAg.</p><p><strong>Materials and methods: </strong>In this study, archived once-thawed serum samples were tested on the Determine HBsAg 2 card and their performance was evaluated in reference to a chemiluminescence-based assay (HBsAg qualitative assay, Abbott Diagnostics, US).</p><p><strong>Results: </strong>A total of 120 patient samples (46 confirmed HBsAg-positive and 74 confirmed HBsAg-negative) were used in this study. The overall median age of the study population was 44 years (IQR: 36-51 years), with a male gender predominance (90%). A specificity of 100% (74/74) and sensitivity of 84.7% (39/46) was observed for the Determine HBsAg 2 assay compared with the reference assay. The samples that showed false-negative results (<i>n</i> = 7) by the card test had HBsAg levels below the limit-of-detection of the card assay.</p><p><strong>Conclusion: </strong>The Determine HBsAg 2 assay gives rapid results in 15 minutes with good sensitivity and specificity. This makes it a good, affordable tool for large-scale screening and public health surveillance programs.</p><p><strong>Clinical significance: </strong>Accurate and cost-effective rapid card tests for early detection of Hepatitis B infection would enable quick isolation of infected cases, thus reducing transmission in the community.</p><p><strong>How to cite this article: </strong>Samal J, Soni A, Pandey A, <i>et al</i>. Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples. Euroasian J Hepato-Gastroenterol 2024;14(1):9-11.</p>\",\"PeriodicalId\":516317,\"journal\":{\"name\":\"Euroasian journal of hepato-gastroenterology\",\"volume\":\"14 1\",\"pages\":\"9-11\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11249907/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Euroasian journal of hepato-gastroenterology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5005/jp-journals-10018-1403\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Euroasian journal of hepato-gastroenterology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5005/jp-journals-10018-1403","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples.
Aim and background: Hepatitis B virus is one of the leading underlying causes of chronic liver disease. Rapid diagnostic tests with improved sensitivity and specificity for detecting hepatitis B infection could aid in large-scale community screening in resource-limited settings. This study was designed to assess the clinical performance of a rapid card test to detect HBsAg.
Materials and methods: In this study, archived once-thawed serum samples were tested on the Determine HBsAg 2 card and their performance was evaluated in reference to a chemiluminescence-based assay (HBsAg qualitative assay, Abbott Diagnostics, US).
Results: A total of 120 patient samples (46 confirmed HBsAg-positive and 74 confirmed HBsAg-negative) were used in this study. The overall median age of the study population was 44 years (IQR: 36-51 years), with a male gender predominance (90%). A specificity of 100% (74/74) and sensitivity of 84.7% (39/46) was observed for the Determine HBsAg 2 assay compared with the reference assay. The samples that showed false-negative results (n = 7) by the card test had HBsAg levels below the limit-of-detection of the card assay.
Conclusion: The Determine HBsAg 2 assay gives rapid results in 15 minutes with good sensitivity and specificity. This makes it a good, affordable tool for large-scale screening and public health surveillance programs.
Clinical significance: Accurate and cost-effective rapid card tests for early detection of Hepatitis B infection would enable quick isolation of infected cases, thus reducing transmission in the community.
How to cite this article: Samal J, Soni A, Pandey A, et al. Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples. Euroasian J Hepato-Gastroenterol 2024;14(1):9-11.
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