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Today, numerous samples from newborns are sent to hospital laboratories for analysis. This takes more time, requires a greater volume of blood and incurs higher costs due to extra labor for laboratory staff. Additionally, the tests are often inaccurate, as it is more difficult to obtain samples from newborns than from adults.

Calmark Neo - the platform

Calmark has developed a point-of-care (POC) diagnostic instrument to make measuring biomarkers for medical conditions in newborns easier and faster. The measuring instrument can document and measure results on the premises, in close proximity to the patient. The POC platform consists of a reader and single-use tests that are placed into the reader during measurement.

The single-use test consists of a separate chamber in which the blood sample is placed. When the lid of the reader closes, the test is activated and the blood sample reaches the filter design. Some of the filters are permeated with chemicals, which react with the relevant substance and produce a color change. This sequence of events takes place in a matter of a few minutes and is patented by the Calmark.

Neo-Reader

Calmark Neo-Reader is a portable, battery-powered and self-instructional reader that will work with Calmark's POC single-use tests. Each test contains the information required for automatic calibration of the results. When closing the lid of the reader, the test is activated and a numeric value is displayed on the reader's screen.

Blood samples may be analyzed whereever the patient is located, eg. return visit at the birth clinic or at the maternity ward. The platform is adapted for hospital environment and is intended for in vitro diagnostics.

  • Safe and easy to use
  • The test results will appear on the screen within minutes
  • Battery capacity: eight working hours, charged with micro-USB connector, charger included
  • Data storage: 25 results are stored locally in the reader
  • Calibrated during manufacturing and does not need to be further calibrated

Neo-Bilirubin

Calmark Neo-Bilirubin quantitatively measures the concentration of bilirubin in whole blood of newborns and is used together with Calmark Neo-Reader.

  • Fast and quantitative measurement of bilirubin
  • Optimized for accurate analysis with just a drop of blood
  • Measurement range 150-500 µmol / L (9-29 mg / dL)
  • No interference from hemolysis up to 2 g/L
  • Accurate results at up to 60% hematocrite

Product leaflet Calmark Neo-Bilirubin

Bilirubin
-
CE marked in
April 2020
LDH
Glucose

Tests in Development

Patents

Patent number Country Description
0602158-8 Sweden Method of determining hypoxia in scalp blood during childbirth
5655307 Japan Method of determining hypoxia in scalp blood during labor
8945824 USA Method of determining hypoxia
0950717-9 Sweden Test system for determining hypoxia-induced cellular damage
1050958-6 Kina Testing system for determining hypoxia induced cellular damage
1151115-1 Sweden System and method for analyzing the risk or presence of organ failure
1151116-9 USA In vitro method for analyzing a comparision of an indicative numberic value to a predetermined threshold so as to asses a likelihood of risk or presence of organ failure
ZL201080054087.0 Sweden Testing system setup and method for testing
9045792 Sweden Testing system setup and method for testing
9228953 USA Testing system arrangement and method for testing
1750028-1 Sweden POC testing system for biomarkers