INTENTED USE
PocTell® Hemoglobin Test Strips are firm plastic strips onto which a multilayer dry reagent is affixed and are intended to be read on the BC-101 Hemoglobin Meter. The test strips function by lysing erythrocytes and converting the released hemoglobin into methemoglobin. This test is for the quantitative determination of hemoglobin (Hb) and calculated hematocrit (Hct) in capillary and venous whole blood. The test strips are for professional use only.
SPECIMEN COLLECTION AND PREPARATION
- Acceptable specimens include fresh capillary or venous blood.
- Fresh capillary or venous blood specimens must be collected and tested immediately.
- Specimens with EDTA or heparin anticoagulants may be used. Preserved specimens must be kept in a closed container and must be used within 8 hours of collection. Mix stored specimens adequately before testing.
- A Capillary Transfer Tube or pipette can be used to collect capillary specimens.
MATERIALS
Materials Provided
1.Hemoglobin Test strips
2.Code chip
3.Package insert
Materials Required But Not Provided
1.Lancing device
2.Sterile lancet
3.Hb meter
4.Latex gloves
5.Gauze for puncture
6.Alcohol swab
ACCURACY
The Hemoglobin meter (x) and Hemoglobin test strips were used by a trained technician to test EDTA preserved venous blood specimens from100 participants. The same specimens were analyzed using ICSH reference method (y). The same testing was performed using capillary blood specimens from another 100 participants. The results are compared below:
|
Specimen |
Slope |
Intercept |
r |
N |
|
Venous blood |
1.0167 |
-0.1441 |
0.986 |
100 |
|
Capillary blood |
0.9760 |
0.3150 |
0.989 |
100 |
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