Independent assessment of a point of care HCV RNA test by laboratory analytical testing and a prospective field study in the U.S
Miller et al.
The finding, in our words
A prospective study of 109 subjects found that 250 μl capillary whole blood microsampling is stable for five hours in a microtainer. This patient-centric, decentralised method successfully detected most HCV genotypes at defined limits using the Xpert HCV test on the GeneXpert Xpress system and the cobas HCV platform.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
A study of decentralised patient-centric microsampling found that 82% of untrained participants, 47 of 57, successfully self-collected acceptable fingerstick blood in Microtainer tubes. All 46 tested samples yielded accurate HIV viral suppression results compared to venipuncture, though this remote monitoring approach is limited to US courier services and temperature conditions.
Fingerstick plasma collected in Microtainer tubes showed 100% concordance with matched venous plasma on the Abbott ARCHITECT SARS-CoV-2 IgG assay, n=109. Fingerstick dried blood spots found high concordance with venous samples, n=61, supporting these microsampling methods for decentralised serology.
Capillary blood samples collected by staff or self-collected by participants showed strong correlation and clinically acceptable agreement with venipuncture for influenza haemagglutination inhibition titers. The small differences observed were not clinically meaningful, and adequate sample volume was achieved in most attempts, supporting the feasibility of decentralised serological testing.
Although most kidney transplant recipients successfully collected capillary blood samples at home, haemolysis and transport conditions affected analyte stability. Agreement with venous sampling was acceptable for haemoglobin and creatinine, but potassium and haematocrit exceeded total allowable error limits.
In a cohort of 62 participants evaluating home self-collection with the TassoPlus device, 38 returned samples, with 29% excluded due to insufficient plasma volume below 200 ΔL. Although viral load measurements in adequate samples correlated well with conventional testing (r = 0.800), the high failure rate and missed detection in low-volume viremic samples indicate that further technical refinements are necessary before clinical adoption.