New device speeds up HIV detection in babies

Kellern Wafula (right), the regional sales
Kellern Wafula (right), the regional sales manager for Diagnostic company Alere, demonstrates to health stakeholders the use of a newly launched Alere HIV1/2 Detect device. PHOTO | COURTESY 

The Health ministry has launched a new diagnostic machine that will allow HIV-positive mothers to get test results for their unborn children in less than an hour compared to the current three months.

The device, called Alere HIV 1/2 Detect, is part of the government’s efforts to cut child mortality by ensuring early detection of the virus.

The portable, rechargable, machines, which were developed by a diagnostics firm called Alere, was launched last week.

HIV diagnosis in grown-ups detects the HIV antibody, but in babies the technology used is Polymerase Chain Reaction (PCR) which tests for the virus’ DNA using expensive equipment rarely found in rural areas.

The lack of PCR kits in rural areas forces hospitals to transport refrigerated blood samples to a handful centralised laboratories in the country with the technology and expertise.

“The entire process from extracting the blood sample, transporting it from the hospital by courier and receiving the results could take as long as three months,” said Umaru Mamo, the head of the National Public Health Laboratory at the Health ministry.

“Some mothers may never even go back to the facility to pick the results due to transport constraints. Sometimes the results come back when it is too late to put the child on medication.”

This lengthy and inefficient process is set to be shortened to just a day using the Alere Detect machine, saving the lives of thousands of children as a result of early detection.

The diagnostic device, which was launched on Friday, has several other advantages besides speedy diagnosis.

Unlike the current diagnostic equipment which requires transportation of samples over long distances, the Alere Detect is used at the point of care, eliminating the risk of contamination during testing in laboratories.

The device is also portable, meaning the clinician can carry it to where the patient is, a handy feature during outreach programmes where mothers cannot make it to hospitals.

Rechargeable batteries make the device independent of power connection while an inbuilt memory that can store up to 1,000 tests results and reduces the chances of losing data.

The gadget can also remotely transmit the data to a central government server, enabling for better policy formulation and disease surveillance.

“Increasingly, PCR methods are becoming automated, thus reducing the potential for errors and increasing the reliability of results,” the World Health Organisation notes on the benefits of the Alere Detect technology.

“Moreover, real-time PCR is considerably shortening the procedure time, allowing for greater throughput and more rapid reporting of results. It is the most widely used initial assay for early infant diagnosis in industrialised countries.”

In 2013 alone, more than 10,257 children died of HIV-related complications in Kenya, a huge portion of these mortalities being due to lack of early diagnosis that would have seen them receive life-saving antiretroviral (ARV) drugs.

Statistics show that only one in four children that need ARV therapy have been put on treatment, a negligible number that contributes to children dying barely a year after they are born.

A United Nations Programme on HIV/Aids progress report on Kenya estimated that there are approximately 79,000 expectant women who need antiretroviral therapy every year.

About 55,544 of them (or 70.3 per cent) being able to access medication and prevent their unborn children from getting infected during pregnancy within the first 12 weeks.

This leaves more than 24,000 babies exposed to infection during birth and breastfeeding every year, a number that has led to 138,000 children below two years being in need of ARVs.

“Early diagnosis of HIV allows health-care providers to offer optimal care and treatment of HIV-infected children, assists in decision-making on infant feeding, and avoids needless stress in mothers and families,” WHO notes.

Step-by-step guide

Alere’s marketing manager Willem Pretorius said that due to immigration, there are new subtypes of HIV/Aids in Africa that had to be considered when designing and developing the gadget.

When testing the gadget in Mozambique, his team discovered a child with HIV subtype 2 which he said is rare in Africa. The machine is able to detect three subtypes of HIV —1M, 1N and 2—simultaneously.

The hand-held machine, he added, is easy to use, with a display panel that shows if it has self-calibrated properly and has an easy step-by-step guide on how to use it until it prints the results.

“The idea was to make the machine as easy to operate as a phone. This will enable shifting this task even to non–medical staff,” said Mr Pretorius.