title: Evaluating operational specifications of point-of-care diagnostic tests: a standardized scorecard.
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.
authors.affiliation: Clinton Health Access Initiative, Maputo, Mozambique.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Lehe
authors.forename: Nádia E
authors.initials: NE
authors.lastname: Sitoe
authors.forename: Ocean
authors.initials: O
authors.lastname: Tobaiwa
authors.forename: Osvaldo
authors.initials: O
authors.lastname: Loquiha
authors.forename: Jorge I
authors.initials: JI
authors.lastname: Quevedo
authors.forename: Trevor F
authors.initials: TF
authors.lastname: Peter
authors.forename: Ilesh V
authors.initials: IV
authors.lastname: Jani
mesh_terms: D018791:CD4 Lymphocyte Count / Q000295:instrumentation* / Q000592:standards; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology; D003955:Diagnostic Tests, Routine / Q000379:methods* / Q000592:standards; D006678:HIV / Q000302:isolation & purification; D015658:HIV Infections / Q000175:diagnosis* / Q000628:therapy; D006801:Humans; D019095:Point-of-Care Systems; D011786:Quality Control