POC Technology
A Point Of Care test is a test performed in the immediate vicinity of a patient to provide a rapid same-day result outside the conventional laboratory environment, in order to facilitate immediate clinical decision-making, including initiation and adjustment of anti-retroviral therapy.
Essential criteria that best define ‘Point of Care’ technologies are:
– Patient Impact – Same-day on-site test results
– Short turn-around time (no more than 20-30 minutes)
– Ease of Use – Easy to use for non-laboratory personnel
– Highly automated with minimal manual steps
– No precise sample measurement or manipulation required.
– Simple sample collection – use of capillary blood will be preferable so that phlebotomists are not required to operate the device.
– Results are easy to read.
Deployment – Consistent electricity and refrigeration are not required – device could operate on battery power or an alternate power source. Portable equipment with no manufacturer or specialized installation required. Long shelf life for consumables (at least 6 months once consumables reach facility though preferably longer). Material waste can be disposed of safely.
Quality Control – Internal QC mechanisms available or Compatible with External Quality Assurance (EQA) schemes.
Cost – Similar in cost to conventional testing methods or equipment and consumables cheap enough for deployment at low volume sites.
Cameroon will use these essential POC criteria to determine which potential technologies fit this definition and exclude technologies that fail to meet these criteria. Cameroon will reserve the right to use evaluation results from other countries of similar conditions for those products that it determines to have the most potential for implementation, according to this definition of POC.
This definition can cover devices or device-free systems including:
a) Non-instrumental systems include disposable systems or devices that vary from reagent test strips for a single test to sophisticated multi-analyte reagent strips incorporating procedural controls
b) Small or desktop analyzers: usually handheld or small devices that may differ by size and type.