Customer Analysis on Point-of-Care CD4 Testing
CUTOMER ANALYSIS ON POC CD4 TESTING: WHAT DO THE CUSTOMER AND END-USERS WANT?
As part of our ongoing diagnostic development work, the Initiative Core Team has undertaken a customer analysis of POC CD4 testing. The analysis took the form of an electronic survey which asked respondents questions about their needs and requirements in a point-of-care CD4 test. The full results are yet to be published but below you will find a snapshot from the questions about the CD4 Initiative test specifications.
Attributes of a POC CD4 test
We asked the respondents to rank in order the test specifications as we wanted to discover which was the most important to the end-users. The respondents were asked to rank the CD4 test specifications in order of preference. The results were (most important first):
1. A test with a simple read-out
2. No cold-chain shipment or storage of the test or reagents.
3. Time to result for < 60 minutes.
4. Low price.
5. Quality assurance materials provided.
6. Easy to use (no more than 2 steps).
7. Stable storage for 12 months at 40oC.
8. All solutions contained within the kit.
9. Ability to perform more than 25 tests/worker/day.
10. Safe and easy disposal.
We asked additional questions about test specifications to confirm that our specifications were still relevant from their inception in 2006.
Storage temperature stability and time
Nearly 60% of respondents asked for test stable at temperatures over 37oC (the CD4 specification is 40oC). The most common shelf-life needed was 12 months (half of the respondents).
Number of tests performed per day
36% of respondents needed 26-50 CD4 counts done per day to match current demand with 18% asking for >50.
How long should the test take?
More than half of respondents believed that maximum time should be 60 minutes whilst a quarter thought that 30 minutes was the most a patient could wait. Longer than 2 hours was not considered acceptable.
Batch testing
We asked the respondents to gauge the importance of batch testing. The most common answer was ‘very important’ with 33% of respondents. Overall more than 80% of respondents marked batch testing from ‘quite important’ to ‘essential’'
Simple to use
We asked 2 questions to the respondents: who is likely to use the test and how many steps are considered maximal to describe it as ‘simple-to-use’. More than half of respondents thought that a nurse would perform the POC CD4 test, closely followed by healthcare workers. Physicians also made up a nearly a quarter of respondents’ replies.
We also asked the maximum number of steps that the test POC CD4 test procedure should contain to be considered ‘simple-to use’. Again, the most popular answer was 3 steps with almost half the vote. 20% of respondents believed that 4 steps were acceptable for a simple test.
Cut-offs for a semi-quantitative test
To end this section we asked what treatment threshold would be most suitable for the respondents’ organisations. Originally the CD4 Initiative specification had asked for a minimum of one-cut-off at 250 cells/mm3. However, despite WHO recommendations, some countries have decided on different treatment decision thresholds depending upon national resources and infrastructure. We asked the respondents to choose a treatment initiation cut-off from the following list:
- 200 cells/mm3
- 250 cells/mm3
- 350 cells/mm3
- 400 cells/mm3
- 500 cells/mm3
The results indicated that more than half of respondents chose 350 cells/mm3 as the treatment threshold. The next most popular choice was 250 cells/mm3 with over 30% of respondents stating that this was the best cut-off for their organisation.
