For most babies, the journey from birth passes through the first week of life without major complications. For a group of children, however, medical conditions lead to a need for care and treatment. To quickly understand the health status of the child is imperative.
One of the most common tests taken on newborns is bilirubin, a biomarker found in the blood and which, in elevated levels, causes jaundice. In 60-80% of newborns, the skin becomes slightly yellowish in the first week of life, which in most cases is harmless. But greatly elevated levels of bilirubin can lead to lasting brain damage if not detected and treated.
Given the large percentage of newborns who turn yellow, blood tests are taken on about 20% of all babies in order to reliably assess the bilirubin level. In those parts of the world where possible, the sample is sent to a laboratory for analysis.
The test tube should be protected from light and analyzed immediately, which for newborn blood tests are done manually, unlike adult blood which can be analyzed automatically. In addition, the blood of newborns easily hemolyzes, the red blood cells burst, and the sample must be retaken. The waiting time from sampling to test results and possible start of treatment can therefore be long.
Calmark's business concept is to develop reliable and easily accessible rapid tests for newborns. With the help of near patient analysis (PNA), the healthcare provider, with a small volume of blood, can obtain a faster result at the location of the child, both in the care unit and as an opportunity for diagnostics for patients who are not in hospital.
The idea is to improve the entire care chain, save time and costs in healthcare and make a big difference in those parts of the world where access to hospital laboratories is limited.
Calmark's goal is to be a global leader in PNA diagnostics during the neonatal period and to offer all relevant tests for newborns in the long term, regardless of where in the world they are born.
Calmark wants all newborns to have a quiet start in life!
• Time spent on laboratory testing of newborn blood — an average of 1.5 hours
• If the blood can not be analyzed, which happens in 5-10% of cases — an average of 3 hours
With Calmark's PNA system:
Calmark's POC system consists of an instrument, the POC analyzer, and a standardized test cassette for measuring biomarkers in the blood of newborn babies. The first CE marked test Neo-Bilirubin measures the level of bilirubin to find those children at risk of jaundice.
The instrument, the POC Analyzer, is a portable, battery-powered and self-instructing reader used in conjunction with Calmark's test cassettes.
The cassette contains a chamber, where the blood sample is applied. When the lid of the instrument is closed, the test is activated and the result is displayed on the display within a couple of minutes. By changing the chemistry of the filters in the test cassette, different tests can be developed and analyzed using the same instrument.