The Bilistick® System
Bilistick® System is a Point-of-Care diagnostic bilirubin assay able to measure on a drop of newborn blood the Total Serum Bilirubin concentration.
It is composed by:
- Bilistick® Reader, a portable rechargeable battery reflectance reader;
- Bilistick® Test strips, test strips with a cell-plasma separator coupled with a nitrocellulose membrane, that separate the plasma from corpuscular components of the blood;
- Bilistick® Sample Transfer Pipettes, used for loading the appropriate volume of blood on the test strip (25µL).
Use of the System
The test with the Bilistick® System requires the collection of a small blood sample directly from a heel stick or a test tube, by using the Bilistick Sample Transfer Pipette, and its application on a Bilistick Test Strip once already inserted in the Bilistick reader. The Strip separates the plasma from corpuscular components of the blood and allows the determination of TSB by reflectance spectroscopy using the Bilistick Reader.
The TSB determination by the Bilistick System does not require the use of reagents simplifying the process of measurement and reducing costs. Once loaded on the strip, the bilirubin concentration result is obtained within 2 minutes.
Bilistick® System Assay Technical Specification
The system can measure bilirubin in plasma with an accuracy comparable to traditional clinical laboratory methods (+/- 0.8 mg/dL) in a bilirubin concentration range of 1-40 mg/dl, at hematocrit level ranging from 25% to 65%.
Components of Bilistick® System: READER
Bilistick® Reader (BM-R001) is an electronic device composed by an optical system able to measure the bilirubin concentration by light reflectance.
The internal software of the reader calculates the bilirubin concentration once the serum diffused by capillarity into the nitrocellulose membrane of the Bilistick® Test Strip.
- The USB Cable (BM-R003a) is used for battery charge through the battery charger provided with the Bilistick® Reader or by connecting the reader to a laptop/computer. The connection of the reader to a laptop/computer by using the USB Cable permits the access to the Bilistick Reader User Interface platform.
- The battery charger (BM-R003b) provided with the Bilistick® Reader is composed by two parts, i.e. the AC/DC Adapter and an AC plug.
Components of Bilistick® System: CONSUMABLES
The disposable Bilistick® Test Strips (BM-C001) are composed by a cell-plasma separator (Filter) coupled with a nitrocellulose (NC) membrane, both encased in a plastic cassette. Once applied the blood in the sample loading well, by using a Bilistick® Sample Transfer Pipette, the filter separates the plasma from cells and allows it to saturate the NC membrane. The bilirubin concentration is determined by reflectance spectroscopy using the Bilistick® Reader.
The Bilistick® Sample Transfer Pipette (BM-C002) is an accessories of Bilistick® Test Strip composed by a Pasteur pipette with an internal glass capillary tube, able to house the exact quantity of blood required by the test.
Components of Bilistick® System: MAINTENANCE
The Bilistick® Calibration kit (BM-C003) is composed by a set of eight standard Calibration Strips, corresponding to different bilirubin values. It is used to calibrate the Bilistick® Reader and guarantee the accuracy of the bilirubin determination in accordance with Reference Method Standards.
The Bilistick® Cleaning kit (BM-C004) is used to clean the Bilistick® Reader optical chamber. It is composed by Bilistick® Cleaning Strips and a Bilistick® Drooper Bottle. Bilistick® Cleaning Strips, allows a proper cleaning of the Bilistick® Reader optical chamber. The drooper bottle is used to facilitate the delivery of the medicinal alcohol drops in the Bilistick® Cleaning strip.