, Volume 30, Issue 3, pp 373–379 | Cite as

Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody

  • Supriya Mahajan
  • Reshu Agarwal
  • Vaishali Rawat
  • Guresh Kumar
  • Manoj Kumar Sharma
  • Ekta GuptaEmail author
Original Article


Rapid diagnostic tests (RDTs) can serve as good alternatives to standard serological assays for hepatitis C virus (HCV) detection in limited resource settings. Aim of this study was to evaluate performance of three Indian manufactured RDTs with chemiluminescent microparticle immunoassay (CLIA) for screening of HCV infection with further evaluation using HCV RNA. Serum samples tested for anti-HCV by CLIA (Architect i1000SR, Abbott Diagnostics, IL, USA) were retrieved from − 80 °C and retested for anti-HCV by three RDTs: Alere Trueline (SD Bioline; Haryana, India) (RDT 1), Benesphera HCV Rapid card test (Avantor Performance Materials India Limited; Uttarakhand, India) (RDT 2), AccuTest HCV (Accurex Biomedical Pvt. Ltd.; Mumbai, India) (RDT 3). HCV RNA results were obtained from hospital information system and anti-HCV reactive but RNA negative cases without treatment were considered as either ‘false positives’ or ‘spontaneous clearance of HCV RNA’. Among 86 samples, 75 (87.2%), 49 (57%), 58 (67.4%) and 51 (59.3%) were reactive by CLIA, RDT1, RDT2 and RDT3, respectively. Taking CLIA as reference standard, RDT 1, 2 and 3 demonstrated sensitivity of 65.30%, 77.33% and 68% respectively. Specificity of all three RDTs was 100% with sensitivity of 97.6–100% above signal/cut-off ratio (S/Co) of 6 by CLIA and 88–100% in all HCV RNA positive cases. Sensitivity of RDTs increased from 65.30–77.33 to 72–82.4% when RNA negative/anti-HCV reactive results were considered as non-reactive. The three RDTs have acceptable sensitivity and specificity in anti-HCV detection especially in RNA positive patients that would require treatment for HCV.


Hepatitis C virus Rapid diagnostic tests Chemiluminescent microparticle immunoassay Anti-HCV HCV RNA 


Compliance with ethical standards

Ethical statement

Institutional Ethics Committee (IEC) of ILBS approved the study protocol.

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

13337_2019_542_MOESM1_ESM.pdf (193 kb)
Flowchart showing the overall evaluation and interpretation of results of the three RDTs and CLIA in relation to HCV RNA (n = 75) (PDF 194 kb)
13337_2019_542_MOESM2_ESM.pdf (274 kb)
Flowchart showing the evaluation of the results of the 3 RDTs in relation to HCV RNA results in cases with S/Co ratio of < 6 via CLIA (n = 34) (PDF 275 kb)
13337_2019_542_MOESM3_ESM.pdf (274 kb)
Flowchart showing the evaluation of the results of the 3 RDTs in relation to HCV RNA results in cases with S/Co ratio of > 6 via CLIA (n = 41) (PDF 275 kb)


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Copyright information

© Indian Virological Society 2019

Authors and Affiliations

  • Supriya Mahajan
    • 1
  • Reshu Agarwal
    • 1
  • Vaishali Rawat
    • 1
  • Guresh Kumar
    • 2
  • Manoj Kumar Sharma
    • 3
  • Ekta Gupta
    • 1
    Email author
  1. 1.Department of Clinical VirologyInstitute of Liver and Biliary SciencesNew DelhiIndia
  2. 2.Department of Clinical ResearchInstitute of Liver and Biliary SciencesNew DelhiIndia
  3. 3.Department of HepatologyInstitute of Liver and Biliary SciencesNew DelhiIndia

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