Bilistick® System

It is composed of the Bilistick® Reader, a portable rechargeable battery reflectance reader, Bilistick® Test Strips with a cell-plasma separator cassette, lastly Bilistick® Sample Transfer Pipettes, used for loading the appropriate volume of blood in the test strip. The test requires the collection of a small blood sample directly from a heel stick or a test tube, by using a Sample Transfer Pipette, and its application on a Test Strip once it was already inserted in the reader. The Bilistick® System has been extensively validating both in Western Countries as well as in Low and Middle-Income Countries. Moreover covering different environments and conditions in which it can be used around the world. By comparing Bilistick® bilirubin results with classic methodologies routinely used in high-quality laboratories of hospitals, in conclusion, it has been demonstrated an excellent correlation of bilirubin results. Therefore several studies support the use of the Bilistick® System for routine Total Serum Bilirubin screening. It may facilitate early identification of newborns requiring phototherapy treatment thus contributing to a substantial reduction of the prevalence of ABE/kernicterus in LMICs.

1. Sample Features:

• Type:-Newborn Infant Whole Blood
• Sample Size:-35μL
• Hematocrit:-25-70%

2. Bilistick Reader:

• Units:-mg/dL and μmol/L
• Range:-1 mg/dL to 40 mg/dL & 17.1 μmol/L to 684.0 μmol/L
• Measure System:-Photometric based in two wavelength at 465 nm and 570nm
• Resolution:-± 0.1 mg/dL / 1.0 μmol/L
• Repeatability:-Over 25 mg/dL: Within ±0.6 mg/dL / 10 μmol/L
• Test Time:-m < 2 minutes (However, it depends on hematocrit)
• Sensors:-Optical Sensor
• Optical Filters:-Glass protection inside the optical chamber
• Calibration:-Standard for periodic calibration
• Blank self-calibration after Test Strip insertion
• Hemolysis:-Automatic System for Hemolysis Detection
• Results Report:-Color display, dimension 36.0 x 29.0 mm
• Interface:-Mini B-USB Port
• Operating Conditions:-Firstly temperature: 15° to 40° C

Secondly storage Conditions:-10° C to 40° C low humidity, most importantly non-corrosive gas atmosphere. Thirdly long-term Storage:-

1. In the case of long-term storage, store the reader at 15-25° C, with low humidity, and a non-corrosive atmosphere.
2. When storing the reader for a period longer than six months, charge the battery at least once at a moment.

Lastly, Power supply:-Mini B USB-DC 5V-0.5A-2.5W Charging Conditions:- Average Charging time: 4 hours (while no bilirubin test are been performed) Charging Temperature:-In between, 15-40° C (However, recommended 15-25° C) Dimensions:-31.3 mm H x 72.9 mm W x 140 mm D Net Weight:-220 gr. Shipping Weight:-760 gr.

3. Power Supply:

Power supply:-USB-DC 5V-1.5A-7.5W In addition, it has UL Certificated Accessory USB Cable:-Type A-Mini B (5Pin) M/M USB 2.0

4. Bilistick® System Test Strips:

Cell-Plasma Separator:-Glass fiber Reading Membrane:-Nitrocellulose Plastic Cassette:-High Impact Polystyrene (HIPS) Dimensions:-3.70 mm H x 15.00 mm W x 48.65 m D Net Weight:-1.86 gr.

5. Bilistick® System Sample Transfer Pipettes:

Composition:-Plastic and Glass Total Length:-70.00 ± 0.20 mm\ Glass Tube Diameter:-1.60 ± 00.02 mm Drawing Capacity:-35.00 ± 2.00 μL As a result, all the features of this product make it very useful.