Sample and procedural control line.
Critical differences between a sample and procedural control line:
- A sample control line will only appear if sufficient sample has been applied to the test strip and the test has run correctly
- A procedural control line will appear from any liquid being applied to the test strip, regardless of whether any blood sample has been applied
The unmitigated risk:
An end user MUST have a way of knowing if they have performed their test correctly. An HIV Self Test with only a procedural control line gives substantial risk of a false negative as there is no way of knowing if insufficient blood has been applied. This is a serious risk to both the individual and public health.
The following videos shows the comparison of a BioSURE HIV Self Test (first video) and an unregulated HIV Self Test being performed incorrectly (second video) i.e. with no blood. The results are very clear - no result with the BioSURE HIV Self Test but a negative result (i.e. a false negative) with the unregulated HIV Self Test.