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

• ELISA
• HBsAg
• PCR
• rapid test

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

• HBsAg
• hızlı test
• ELISA
• PCR

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