Hepatit B Yüzey Antijeninin Saptanması için Hızlı Tanı Testinin Enzime Bağlı İmmünosorbent Testi ve PCR ile Karşılaştırılması
Abstract
Amaç: Hepatit B virüs (HBV) enfeksiyonu, önemli morbidite ve mortalite oranları ile küresel halk sağlığı sorunu olmaya devam etmektedir ve tanı için HBs Ag'nin tespiti çok önemlidir. İdeal olarak hızlı testlerin duyarlılığının yüksek özgüllüğününde kabul edilebilir yükseklikte olması gerekir, böylelikle yanlış pozitif ve yanlış negatif sonuçların önüne geçilebilir. Bu çalışmanın amacı, ELISA ve PCR ile doğrulanmış vakalarla hızlı tarama testlerinin performansını değerlendirmektir.
Araçlar ve Yöntem: Prospektif olarak planlanan bu çalışma Şubat 2024-Mart 2024 tarihleri arasında Samsun'da üçüncü basamak bir hastanede gerçekleştirilmiştir. HBsAg testi için mikrobiyoloji laboratuvarına çeşitli kliniklerden gönderilen toplam 160 kan örneği çalışmaya dahil edilmiştir. Tüm örnekler ELISA ve PCR yöntemi ile çalışıldıktan sonra hızlı test ile çalışılmıştır.
Bulgular: ELISA ile karşılaştırıldığında hızlı testin özgüllüğü %97.70, duyarlılığı %87.20, pozitif prediktif değeri (PPV) %57.82, negatif prediktif değeri (NPV) %99.53olarak saptanmıştır. Ayrıca HBsAg hızlı testi PCR ile karşılaştırıldığında duyarlılığı %44.50, özgüllüğü ise %47.40 olarak belirlenmiştir.
Sonuç: Çalışmamız ile hızlı testlerin ELISA ile karşılaştırıldığında yüksek özgüllük ve kabul edilebilir duyarlılığa sahip olduğu ancak PCR ile karşılaştırıldığında yeterince uyumlu olmadığı sonucuna varılmıştır.
Keywords
References
- 1. Chen DS. Toward elimination and eradication of hepatitis B. J Gastroenterol Hepatol. 2010;25(1):19-25.
- 2. Wen WH, Chen HL, Ni YH, et al. Secular trend of the viral genotype distribution in children with chronic hepatitis B virus infection after universal infant immunization. Hepatology. 2011;53(2):429-436.
- 3. World Health Organization. Global Health Sector Strategy on Viral Hepatitis 2016–2021. Towards Ending Viral Hepatitis. https://apps.who.int/iris/handle/10665/246177 Geneva, Switzerland:2016. Accessed date 10 March, 2024.
- 4. Hsu YC, Huang DQ, Nguyen MH. Global burden of hepatitis B virus: current status, missed opportunities and a call for action. Nat Rev Gastroenterol Hepatol. 2023;20(8):524-537.
- 5. Prabha P, Saikeerthana D, Vijayashree V, Gogan MA. Comparison of Rapid Screening Test and ELISA for the Diagnosis of Hepatitis B Surface Antigen in Patients Attending a Tertiary Care Hospital, Tamil Nadu, India. Natl. Lab. Med. 2022;11(1):22-25.
- 6. Khadem MA, Omrani MD, Movahedi V. Comparative Evaluation of Immunochromatographic Rapid Diagnostic Tests (Strip and Device) and PCR Methods for Detection of Human Hepatitis B Surface Antigens. Hepat. Mon. 2007;7(2):87-91.
- 7. Al-Matary AM, Al Gashaa FAS. Comparison of different rapid screening tests and ELISA for HBV, HCV, and HIV among healthy blood donors and recipients at Jibla University Hospital Yemen. J Med Life. 2022;15(11):1403-1408.
- 8. Erhabor O, Kwaifa IK, Bayawa AM, et al. Comparison of ELISA and rapid screening techniques for the detection of HBsAg among blood donors in Usmanu Danfodiyo University Teaching Hospital Sokoto, North Western Nigeria. J Blood Lymph. 2014;4(2): 124.
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- 10. Nagpal B, Kumari J, Mehta J. Comparison of accuracy of ELISA technique and RAPID screening techniques for Diagnosis of Hepatitis B surface antigen (HBsAg). J Microbi ol Curr Res. 2021;5(2):1-3.
- 11. Dembele B, Affi-Aboli R, Kabran M, et al. Evaluation of Four Rapid Tests for Detection of Hepatitis B Surface Antigen in Ivory Coast. J Immunol Res. 2020;2020(1):6315718.
- 12. Plitt SS, Somily AM, Singh AE. Outcomes from a Canadian public health prenatal screening program for hepatitis. Can J Public Health. 2007;98:194-197.
- 13. Lau DT, Ma H, Lemon SM, et al. A rapid immunochromatographic assay for hepatitis B virus screening. J Viral Hepat. 2003;10(4):331-334.
- 14. Tiwari YK, Pundir S, Saraf G, et al. A Comparison of Rapid Card Test with Enzyme-Linked Immunosorbent Assay for the Detection of Hepatitis B Surface Antigen [HBsAg] in tertiary care hospital. RRJoMV. 2017;7(3):27-31.
- 15. Shrivastava RK, Chaurasia D. Evaluation of rapid diagnostic test compared with ELISA for detection of hepatitis B surface antigen. Indian J Microbiol Res. 2020;7(2):203-206.
- 16. Shreffler J, Huecker MR. Diagnostic Testing Accuracy: Sensitivity, Specificity, Predictive Values and Likelihood Ratios. Treasure Island: StatPearls Publishing;2025.
- 17. Navvabi N, Khadem Ansari MH, Navvabi A, Chalipa HR, Zitricky F. Comparative assessment of immunochromatography and ELISA diagnostic tests for HBsAg detection in PCR-confirmed HBV infection. Rev Gastroenterol Mex (Engl Ed). 2022;87(2):176-180.
Comparison of Rapid Diagnostic Test with Enzyme-Linked Immunosorbent Assay and PCR for Detection of Hepatitis B Surface Antigen
Abstract
Purpose: Hepatitis B virus (HBV) infection is a global public health problem with significant morbidity and mortality rates and the detection of HBsAg is a very important test for diagnosis. Ideally, rapid tests should have a high sensitivity and an acceptable level of specificity, so that false positive and false negative results can be prevented. The objective of this study was to evaluate the performance of rapid screening tests with confirmed cases with ELISA and PCR.
Materials and Methods: This study was conducted as a prospective study in a tertiary hospital in Samsun between February 2024 and March 2024. A total of 160 blood samples sent to the microbiology laboratory for HBsAg testing from various departments were included in the study. All samples were studied with a rapid test after being studied with ELISA and PCR methods.
Results: Compared to ELISA, the rapid test had a specificity of 97.70%, a sensitivity of 87.20%,a positive predictive value (PPV) of 57.82% and a negative predictive value (NPV) of 99.53%. In addition, when the HBs Ag rapid test was compared with PCR, the sensitivity was 44.50% and the specificity was 47.40%.
Conclusion: Our study concluded that rapid tests have high specificity and acceptable sensitivity compared to ELISA, but they are not sufficiently consistent when compared to PCR.
Keywords
References
- 1. Chen DS. Toward elimination and eradication of hepatitis B. J Gastroenterol Hepatol. 2010;25(1):19-25.
- 2. Wen WH, Chen HL, Ni YH, et al. Secular trend of the viral genotype distribution in children with chronic hepatitis B virus infection after universal infant immunization. Hepatology. 2011;53(2):429-436.
- 3. World Health Organization. Global Health Sector Strategy on Viral Hepatitis 2016–2021. Towards Ending Viral Hepatitis. https://apps.who.int/iris/handle/10665/246177 Geneva, Switzerland:2016. Accessed date 10 March, 2024.
- 4. Hsu YC, Huang DQ, Nguyen MH. Global burden of hepatitis B virus: current status, missed opportunities and a call for action. Nat Rev Gastroenterol Hepatol. 2023;20(8):524-537.
- 5. Prabha P, Saikeerthana D, Vijayashree V, Gogan MA. Comparison of Rapid Screening Test and ELISA for the Diagnosis of Hepatitis B Surface Antigen in Patients Attending a Tertiary Care Hospital, Tamil Nadu, India. Natl. Lab. Med. 2022;11(1):22-25.
- 6. Khadem MA, Omrani MD, Movahedi V. Comparative Evaluation of Immunochromatographic Rapid Diagnostic Tests (Strip and Device) and PCR Methods for Detection of Human Hepatitis B Surface Antigens. Hepat. Mon. 2007;7(2):87-91.
- 7. Al-Matary AM, Al Gashaa FAS. Comparison of different rapid screening tests and ELISA for HBV, HCV, and HIV among healthy blood donors and recipients at Jibla University Hospital Yemen. J Med Life. 2022;15(11):1403-1408.
- 8. Erhabor O, Kwaifa IK, Bayawa AM, et al. Comparison of ELISA and rapid screening techniques for the detection of HBsAg among blood donors in Usmanu Danfodiyo University Teaching Hospital Sokoto, North Western Nigeria. J Blood Lymph. 2014;4(2): 124.
- 9. Megha S, Saroj G, Mehra SK, Jani MV. A comparative evaluation of rapid card test with enzyme-linked immunosorbent assay for the detection of HBsAg among pregnant women in a tertiary care hospital. Int Arch Bio Med Clin Res. 2019;5(1):31-33.
- 10. Nagpal B, Kumari J, Mehta J. Comparison of accuracy of ELISA technique and RAPID screening techniques for Diagnosis of Hepatitis B surface antigen (HBsAg). J Microbi ol Curr Res. 2021;5(2):1-3.
- 11. Dembele B, Affi-Aboli R, Kabran M, et al. Evaluation of Four Rapid Tests for Detection of Hepatitis B Surface Antigen in Ivory Coast. J Immunol Res. 2020;2020(1):6315718.
- 12. Plitt SS, Somily AM, Singh AE. Outcomes from a Canadian public health prenatal screening program for hepatitis. Can J Public Health. 2007;98:194-197.
- 13. Lau DT, Ma H, Lemon SM, et al. A rapid immunochromatographic assay for hepatitis B virus screening. J Viral Hepat. 2003;10(4):331-334.
- 14. Tiwari YK, Pundir S, Saraf G, et al. A Comparison of Rapid Card Test with Enzyme-Linked Immunosorbent Assay for the Detection of Hepatitis B Surface Antigen [HBsAg] in tertiary care hospital. RRJoMV. 2017;7(3):27-31.
- 15. Shrivastava RK, Chaurasia D. Evaluation of rapid diagnostic test compared with ELISA for detection of hepatitis B surface antigen. Indian J Microbiol Res. 2020;7(2):203-206.
- 16. Shreffler J, Huecker MR. Diagnostic Testing Accuracy: Sensitivity, Specificity, Predictive Values and Likelihood Ratios. Treasure Island: StatPearls Publishing;2025.
- 17. Navvabi N, Khadem Ansari MH, Navvabi A, Chalipa HR, Zitricky F. Comparative assessment of immunochromatography and ELISA diagnostic tests for HBsAg detection in PCR-confirmed HBV infection. Rev Gastroenterol Mex (Engl Ed). 2022;87(2):176-180.
Details
| Primary Language | English |
|---|---|
| Subjects | Clinical Microbiology |
| Journal Section | Original Articles |
| Authors | |
| Early Pub Date | April 16, 2025 |
| Publication Date | April 21, 2025 |
| Submission Date | March 21, 2024 |
| Acceptance Date | December 12, 2024 |
| Published in Issue | Year 2025 Volume: 9 Issue: 1 |
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Ahi Evran Medical Journal is indexed in ULAKBIM TR Index, Turkish Medline, DOAJ, Index Copernicus, EBSCO and Turkey Citation Index. Ahi Evran Medical Journal is periodical scientific publication. Can not be cited without reference. Responsibility of the articles belong to the authors.
