Can we trust published evidence on point-of-care tests for cholesterol? A rapid review.

Objectives: There is a need to better inform clinicians and decision-makers in primary or community care settings on selecting the appropriate point-of-care tests (POCTs) for screening purposes (as a part of the NHS Health Check Programme). Here we provide an overview of the published analytic validity and diagnostic accuracy studies on POCTs for measuring blood lipids that are available on the UK market to determine whether they meet the accuracy specifications based on the 1995 US National Cholesterol Education Program (NCEP) recommendations.

Design: Rapid review of analytical validity and diagnostic accuracy studies.

Data Sources: On 12 May 2023, Medline and Embase were searched. Google Scholar was manually scrutinised to identify additional studies. Key article reference lists were also hand-searched.

Eligibility Criteria: We included analytical validity and diagnostic accuracy studies that compared POCT to laboratory testing (or another POCT) performance for measuring at least total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C).

Data Extraction And Synthesis: Identified studies were independently reviewed by two researchers using standardised methods of screening. Where necessary, conflicts were resolved by a third reviewer. Title and abstract as well as full texts were screened using prespecified inclusion and exclusion criteria. The quality of identified studies was assessed using QUADAS-2 for diagnostic accuracy studies and a modified quality appraisal tool for studies of diagnostic reliability (QAREL) for analytical validity studies. We assessed the quality of analytical and diagnostic accuracy studies and compared the accuracy of the POCTs for TC, triglyceride (TG), HDL-C and low-density lipoprotein cholesterol (LDL-C) against NCEP standards for mean per cent bias, coefficient of variation or total error. We narratively synthesised analytical and clinical validity evidence from retrieved studies.

Results: This study examined analytical and diagnostic accuracy evidence for the selected POCTs. Through the review of 22 studies, 6 POCTs were identified. All retrieved studies were analytical validity assessments, while five of them also reported diagnostic accuracy information. The majority of evidence focused on Cholestech LDX, CardioChek PA and Accutrend Plus. Evidence of between and within-study heterogeneity was found. Precision measures often showed systematic differences between the POCT and reference standards. Most devices, except for Elemark, met at least one NCEP standard for either TC, TG, HDL-C, or LDL-C.

Conclusions: We found that evidence for two of the devices mostly met the requirements of the NCEP standard of evidence for bias and precision and could be recommended to general practitioners to use in the NHS Health Check programme. These were the Cholestech LDX and the Cobas b101 system.