Author(s)

Zhang Lei ¹, Yang Feng ², Zhu Junzhe ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Yipeng Street, Qiantang District, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

Hepatitis C virus (HCV) is a bloodborne pathogen that primarily targets the liver, leading to the development of chronic liver disease. Timely identification and effective management of HCV infection are essential to prevent complications and halt further transmission. The aim of this study was to evaluate the diagnostic efficacy of the HCV Rapid Test Cassette, an immunoassay that employs specific antibodies to qualitatively detect HCV antibodies directed against viral antigens. To assess the sensitivity, specificity, and accuracy of the HCV Rapid Test, we utilized a comprehensive collection of 936 seroconversion panels. The test demonstrated an accuracy of 99.0%, with a sensitivity of 98.7% and a specificity of 99.1%. The specificity of the test was confirmed through cross-reactivity testing, which yielded negative results for various viral strains. Developed by Hangzhou All Test Biotech Co., Ltd, the HCV Rapid Test offers high accuracy, reliability, and rapid results, making it a valuable adjunctive diagnostic tool in clinical settings, particularly in resource-limited environments. Early identification facilitated by this test enables timely intervention and effective management of Hepatitis C, leading to improved patient outcomes and reduced viral transmission.

KEYWORDS

Hepatitis C; Diagnosis; Point-of-care; Specificity

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Evaluation of the Sensitivity, Specificity and Accuracy of the HCV Rapid Test Cassette for Detecting HCV Antibodies in Serum or Plasma Specimens. MEDS Clinical Medicine (2024) Vol. 5: 132-137. DOI: http://dx.doi.org/10.23977/medsc.2024.050221.

REFERENCES

[1] Ryan KJ, Ray CG, eds. (2004). Sherris Medical Microbiology (4th ed.). McGraw Hill. pp. 551–552.
[2] World Health Organization. Global hepatitis report 2024: action for access in low- and middle-income countries.
[3] Basu D, Sharma AK, Gupta S, Nebhinani N, Kumar V. Hepatitis C virus (HCV) infection & risk factors for HCV positivity in injecting & non-injecting drug users attending a de-addiction centre in northern India. Indian J Med Res 2015; 142(3):311-316. 
[4] Tordrup D, Hutin Y, Stenberg K, Lauer JA, Hutton DW, Toy M, et al. Additional resource needs for viral hepatitis elimination through universal health coverage: projections in 67 low-income and middle-income countries, 2016–2030. Lancet Glob Health 2019; 7(9):e1180–e1188.
[5] "Hepatitis C Fact sheet". WHO. 24 June 2022. Archived from the original on 31 January 2016. Updated as required. 
[6] Teuber G, Schafer A, Rimpel J, et al. Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: association with demographic factors, inflammatory activity, and degree of fibrosis. J Hepatol 2008; 49: 923-929.
[7] World Health Organization. Guidelines on hepatitis B and C testing. https://www.who.int/hepatitis/ publications/ guidelines-hepatitis-c-b-testing/en/. Accessed 9 July 2020.
[8] Villar LM, Cruz HM, Barbosa JR, Bezerra CS, Portilho MM, Scalioni LP. Update on hepatitis B and C virus diagnosis. World J Virol 2015; 4:323–342.
[9] St John A, Price CP. Economic evidence and point-of-care testing. Clin Biochem Rev 2013; 34:61–74.

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