Evaluation of a Chip-Based, Point-of-Care, Portable, Real-Time Micro PCR Analyzer for the Detection of High-Risk Human Papillomavirus in Uterine Cervix in India

JCO Glob Oncol. 2020 Jul;6:1147-1154. doi: 10.1200/GO.20.00024.

Abstract

Purpose: Currently available human papillomavirus (HPV) detection devices are expensive, requiring a continuous power supply, high-priced reagents, skilled laboratory personnel, and infrastructure. These make it difficult to implement primary HPV screening in high-risk (HR) populations, particularly in low-income settings such as in India. The objective of our study was to evaluate the diagnostic performance of a point-of-care, portable, battery-operated device called Truenat, which detects 4 HR HPV genotypes (16, 18, 31, and 45), as a potentially cost-effective alternative to conventional HPV diagnostic tests.

Patients and methods: This was a single-site, blinded, cross-sectional study that evaluated the performance of the Trunat HPV-HR using cervical samples collected from nonpregnant women > 30 years old via consecutive sampling. The comparison was conducted against the Hybrid Capture 2 (HC2) method. All the positive samples were validated by 14 Real-TM Quant Kit.

Results: Of 615 cervical samples, the HR-HPV DNA test was positive in 78 women (12.7%) by HC2 and in 49 (8%) by Truenat. With the consideration of limited genotype inclusivity, the sensitivity and specificity of Truenat HPV-HR were 97.7% and 98.9%, respectively.

Conclusion: The performance of Truenat HPV-HR test was comparable to that of HC2 in the 4 HPV genotypes and would be appropriate to consider for use in primary HR cervical cancer screening and particularly in low-income settings.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alphapapillomavirus*
  • Cross-Sectional Studies
  • DNA, Viral / genetics
  • Early Detection of Cancer
  • Female
  • Humans
  • India
  • Papillomavirus Infections* / diagnosis
  • Point-of-Care Systems
  • Reagent Kits, Diagnostic
  • Real-Time Polymerase Chain Reaction
  • Uterine Cervical Neoplasms* / diagnosis

Substances

  • DNA, Viral
  • Reagent Kits, Diagnostic