BILITEST - device for objective evaluation of hyperbilirubinemia level in newborns using non-invasive transcutaneous method.
The intended use of the BILITEST Hyperbiliruinemia Analyzer is to screen newborn infants for hyperbilirubinemia, including:
to determine the degree of jaundice and to monitor its dynamics;
to identify newborn infants whose degree of hyperbilirubinmia indicates that a serum bilirubin test is (is not) necessary;
to assess the therapy efficiency.
Commonly in newborns bilirubin determination is performed on a forehead near nose or on the upper part of the breast. Only a slight touch of a mobile measuring head to a baby’s derma is needed for measuring. The result is given in international units for transcutaneous bilirubin index (TBI). This index has a high correlation degree with plasma bilirubin concentration (0,92).
1. Method of measurement – reflectance bichromatic photometry.
2. Light source – two white light-emitting diodes (LED).
3. Detector - two photocell system.
4. Measuring range - 0-50 (in unit of TBI) approximately corresponds to 0-500 μmol/l .
5. Optical unaccuracy - <10%.
Imprecision (CV%) - <2%.
a) Metrological characteristics have been verified by Russian Federation State Commitee for Standartization and Metrology Body on the basis of five Reference Reading Checkers.
b) Control Reading Checker's data should be within the limits specified directly on the spots of Checker's installation within the covering.
6. Correlation between TBI and laboratory values for serum bilirubin levels - more or equal to 0.92.
7. Readout - three digits liquid crystal display (LCD).
8. Measuring cycle time - ~2 seconds. Between the measuring cycles the device is in a stand-by mode.
9. Power source – 3 batteries of AAA (or LR03) type.
10. The number of measuring cycles without replacing the batteries (during battery life) - >100,000
11. Weight (with batteries) - 150 grams.
12. Dimensions Width x Height x Depth - 65x135x35 mm.