By Patrick Kagenda
A new clinical gadget, MyT4CD4, which is being marketed as the latest CD4-testing gadget has hit the Ugandan market. The sellers of the gadget say it is “a rapid, service-free, Point-of-Care CD4 test that provides quantitative CD4 results in 10 minutes and is the fastest CD4 test available.”
It is said to enable a patients to be tested and receive results during a single clinic visit. MyT4 CD4 has CE-IVD Mark regulatory approval.
According to the Clinton Health Access Initiative over 40% of HIV patients in Africa have limited access to CD4 testing. Conventional CD4 tests are done on flow cytometers, which are designed for large labs with continuous electricity, refrigeration, and detailed sample preparation and quality control.
Most health facilities cannot support the capital cost, infrastructure and human resource requirements for a flow cytometer, so CD4 testing is provided by transporting samples from clinics to central labs for testing on a flow cytometer, then sending the results back to the clinic.
Patients have to return to the clinic to get results, which can take weeks or months to be available. Clinton Health Access Initiative data indicates that 46% of tests are not matched with a patient for clinical decisions making.
The POC CD4 test currently used in Africa has a 20 minute time-to-result. MyT4 CD4 cuts this time-to-result in half so an operator can provide CD4 results for twice as many patients in one day.
According to its promoters, as a quantitative test, MyT4 CD4 can be used to determine whether a newly diagnosed patient qualifies for anti-retroviral treatment (ART) initiation. The test can also be used for regular long-term CD4 monitoring for chronic HIV patients when viral load monitoring is not available, which is recommended by the WHO every 6 months.
The quantitative MyT4 test can be used for treatment initiation at any threshold, which is valuable because today programs do not all use the same cut-off with most using 350 cells/µL or 500 cells/µL depending on country guidelines.
Instrument based CD4 tests require high capital investment to adopt the system ($6500 for POC or $27,000 for flow cytometry). The MyT4 CD4 Accessory is about 10 times less than the capital investment required for other POC CD4, so with the same funding, a healthcare system can provide CD4 testing at 10 times as many sites with MyT4’s high throughput at every site.
According to the dealers, this also means the MyT4 is cost-effective regardless of the number of tests run each day. As countries implement viral load for monitoring, the MyT4 is a great choice because they don’t need to invest in instruments or worry about costs going up as CD4 volume goes down.
MyT4 CD4 is designed so that any healthcare worker can use it effectively with a few hours of training and uses venous or capillary whole blood. It has fully-contained reagents and internal quality controls. This means that no preparation of the sample, reagents, or controls is required and can hold 50 tests-per-charge despite power fluctuations and partial charging and discharging.
MyT4 CD4 is service-free, which means there are no maintenance, no calibration, and no service contracts. MyT4 CD4 accessories will be replaced if broken, with no swap of broken units required.
A validation study completed in South Africa in December 2013 and in Kenya both at the KEMRI Alupe and the National HIV reference lab shows results equivalent to the gold standard, flow cytometry.
Key attributes of this rapid, service-free, point-of-care test
MyT4 CD4 is service-free, which means there are no maintenance, no calibration, and no service contracts. MyT4 CD4 Accessories will be replaced if broken, with no swap of broken units required.
MyT4 CD4 has a very low cost to start or switch from existing platforms.
MyT4 CD4 is a fully-quantitative test with intuitive visual read-out. As a quantitative test, MyT4 CD4 can be used to determine whether a newly diagnosed patient qualifies for anti-retroviral treatment (ART) initiation. The test can also be used for regular long-term CD4 monitoring for chronic HIV patients when viral load is not available, which is recommended by the WHO every 6 months.
Internal quality controls (IQC) are built into both the MyT4 CD4 Test and the MyT4 CD4 Accessory. IQC enables operators to identify errors immediately to ensure patients get correct results. Three IQC indicators in the MyT4 Test show whether the test has run to completion or whether an error has occurred. IQC indicators in the MyT4 Accessory check the calibration of the key parameters, time and speed, for every test-run. Indicator lights inform the operator of any errors.
MyT4 CD4 contains a robust rechargeable battery that holds 50 tests-per-charge. It charges through mains power or automobile. The battery allows the MyT4 CD4 to be used at sites with limited electricity infrastructure, and for outreach to remote areas.
Healthcare facilities do not need to have consistent power and refrigeration equipment to use MyT4 CD4; it can be stored at room temperature and MyT4 CD4 Tests have a 12-month shelf-life and no cold-chain required.