Evaluating operational specifications of point-of-care diagnostic tests: a standardized scorecard

PLoS One. 2012;7(10):e47459. doi: 10.1371/journal.pone.0047459. Epub 2012 Oct 31.

Abstract

The expansion of HIV antiretroviral therapy into decentralized rural settings will increasingly require simple point-of-care (POC) diagnostic tests that can be used without laboratory infrastructure and technical skills. New POC test devices are becoming available but decisions around which technologies to deploy may be biased without systematic assessment of their suitability for decentralized healthcare settings. To address this, we developed a standardized, quantitative scorecard tool to objectively evaluate the operational characteristics of POC diagnostic devices. The tool scores devices on a scale of 1-5 across 30 weighted characteristics such as ease of use, quality control, electrical requirements, shelf life, portability, cost and service, and provides a cumulative score that ranks products against a set of ideal POC characteristics. The scorecard was tested on 19 devices for POC CD4 T-lymphocyte cell counting, clinical chemistry or hematology testing. Single and multi-parameter devices were assessed in each of test categories. The scores across all devices ranged from 2.78 to 4.40 out of 5. The tool effectively ranked devices within each category (p<0.01) except the CD4 and multi-parameter hematology products. The tool also enabled comparison of different characteristics between products. Agreement across the four scorers for each product was high (intra-class correlation >0.80; p<0.001). Use of this tool enables the systematic evaluation of diagnostic tests to facilitate product selection and investment in appropriate technology. It is particularly relevant for countries and testing programs considering the adoption of new POC diagnostic tests.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • CD4 Lymphocyte Count / instrumentation*
  • CD4 Lymphocyte Count / standards
  • CD4-Positive T-Lymphocytes / cytology
  • Diagnostic Tests, Routine / methods*
  • Diagnostic Tests, Routine / standards
  • HIV / isolation & purification
  • HIV Infections / diagnosis*
  • HIV Infections / therapy
  • Humans
  • Point-of-Care Systems*
  • Quality Control

Grants and funding

This work was supported by grants from Absolute Return for Kids (http://www.arkonline.org/ - ARK-CHAI Point-of-care Project) and UNITAID (http://www.unitaid.eu/hivaids-projects?id=154 - the UNITAID-CHAI Pediatric HIV/AIDS Project). The funders of this study had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.