BiliSpec a low-cost, battery-powered reader designed to diagnose jaundice by immediately quantifying serum bilirubin levels from a small drop of whole blood, has successfully passed its first clinical trial in Malawi.
The first clinical study of a low-cost, hand-held jaundice detector invented by Rice University students couldn’t have come at a better time for NEST360°, an international team of scientists, doctors and global health experts preparing for a competition for $100m from the MacArthur Foundation. The money would allow the team to carry out its visionary plan to halve the number of new-born deaths in African hospitals within 10 years.
“As the clinical study of BiliSpec shows, saving new-born lives in sub-Saharan Africa is achievable,” said NEST360°’s Rebecca Richards-Kortum, a Rice bioengineering professor and study co-author who has worked for more than a decade to bring effective, affordable neonatal technologies like BiliSpec to Africa. “It simply requires the right tools in the right hands at the right time.”
The clinical study is based on tests in February and March on 68 patients at Queen Elizabeth Central Hospital in Blantyre, Malawi.
BiliSpec is a low-cost, battery-powered reader designed to diagnose jaundice by immediately quantifying serum bilirubin levels from a small drop of whole blood.
Jaundice, which is caused by the build-up of bilirubin in the bloodstream, affects about 60% of new-borns and can cause severe, untreatable brain damage or death if it is untreated. Standard jaundice tests require multiple expensive disposables and laboratory equipment like centrifuges or spectrophotometers that African hospitals typically cannot afford.
Babies in sub-Saharan Africa are about 100 times more likely to die of jaundice than are babies in the US, partly because doctors diagnosing jaundice in sub-Saharan Africa have little to go on other than what their eyes tell them. “Clinicians in sub-Saharan Africa typically diagnose jaundice by looking at a child and gauging the colour of their skin or the whites of their eyes,” said study co-author Pelham Keahey, a Rice applied physics graduate student who worked alongside clinicians at Queen Elizabeth Central Hospital to gather data for the study.
The study showed that BiliSpec has comparable accuracy to the more expensive laboratory tests found in high-resource settings. Each BiliSpec test costs about 5c and can be performed in about two minutes right at the patient’s bedside. The price is important because it could bring testing for jaundice within reach for cash-strapped hospitals in sub-Saharan Africa.
“The next step is a larger, two-year follow-up study of efficacy and usability that will be conducted at five hospitals in Malawi,” Keahey said. Rice won funding for the follow-up study in August from Saving Lives at Birth, a joint undertaking by the US Agency for International Development (USAID), the Bill & Melinda Gates Foundation and the governments of Norway, Canada and South Korea.
BiliSpec is one component of a 17-piece neonatal package called NEST (Newborn Essential Solutions and Technologies), that is designed specifically for African hospitals.
Newborns are at increased risk of jaundice, a condition in which excess bilirubin accumulates in blood. Left untreated, jaundice can lead to neurological impairment and death. Jaundice resulting from unconjugated hyperbilirubinemia is easily treated with exposure to blue light, and phototherapy systems have been developed for low-resource settings; however, there are no appropriate solutions to diagnose and monitor jaundice in these settings. To address this need we present BiliSpec, a low-cost reader and disposable lateral flow card designed to measure the concentration of total bilirubin from several drops of blood at the point of care. We evaluated the performance of BiliSpec, using blood from normal volunteers spiked with varying amounts of bilirubin; results measured using BiliSpec correlated well with a reference laboratory bilirubinometer (r = 0.996). We then performed a pilot clinical study using BiliSpec to measure total bilirubin in neonates at risk for jaundice at Queen Elizabeth Central Hospital in Blantyre, Malawi. Concentrations measured using BiliSpec correlated well with those measured using a laboratory reference standard in 94 patient samples ranging from 1.1 mg/dL to 23.0 mg/dL in concentration (r = 0.973). The mean difference between bilirubin levels measured with BiliSpec and the reference standard was 0.3 mg/dL (95%% CI: −1.7–2.2 mg/dL).
Pelham A Keahey, Mathieu L Simeral, Kristofer J Schroder, Meaghan M Bond, Prince J Mtenthaonnga, Robert H Miros, Queen Dube, Rebecca R Richards-Kortum