Intended Use
Chemistry calibrator is intended for the calibration of quantitative assays on automated and semi-automated analyzers.
Product Description
The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values.
Precautions
For in vitro diagnostic use only. Human serum was used in the manufacture of this product. Each donor unit was tested with licensed reagents and found negative for the HIV antibody. Because no test method can offer complete assurance that products derived from blood will not transmit infectious agents, it is recommended that this product be handled with the same precautions used for patient specimens.
Storage and Stability
Unreconstituted chemistry calibrator is stable until the expiration date when stored at 2-8°C. Reconstituted chemistry calibrator is stable for seven days when stored at 2-8°C with the exception of bilirubin, which is stable five days at 2-8°C.
General Instructions For Use
Using a volumetric pipette, add exactly 5.0ml of diluent to the lyophilized serum. Gently invert the vial intermittently over a period of 20 minutes to ensure complete dissolution of contents. Immediately prior to use, gently invert the vial 5 – 10 times. Follow the calibration procedure recommended by the instrument manufacturer.
ANALYTE |
Pointe 180 |
ASCA / AGII |
ATAC |
COBAS
MIRA |
Express
550 |
RA
500/1000 |
Hitachi
717
|
Hitachi
917 |
Beckman
CX
System |
Selectra |
Units |
Albumin |
3.8 |
4.0 |
4.0 |
4.0 |
3.8 |
3.7 |
3.9 |
3.9 |
3.9 |
3.9 |
g/dl |
T. Bilirubin |
4.2 |
5.2 |
4.5 |
4.3 |
4.2 |
3.6 |
3.0 |
3.5 |
4.0 |
4.1 |
mg/dl |
D.Bilirubin |
---- |
1.5 |
1.7 |
1.7 |
1.8 |
2.1 |
2.6 |
2.6 |
2.6 |
2.1 |
mg/dl |
BUN |
48 |
50 |
53 |
50 |
55 |
52 |
51 |
51 |
53 |
47 |
mg/dl |
Calcium |
9.8 |
9.1 |
10.0 |
9.9 |
9.3 |
9.9 |
9.5 |
9.5 |
9.6 |
9.5 |
mg/dl |
CO2 |
25 |
22 |
---- |
26 |
22 |
24 |
27 |
27 |
24 |
26 |
mEq/L |
Chloride |
90 |
---- |
---- |
105 |
104 |
102 |
---- |
---- |
---- |
---- |
mEq/L |
Cholesterol |
201 |
202 |
210 |
205 |
212 |
209 |
210 |
210 |
217 |
217 |
mg/dl |
Creatinine |
4.2 |
3.9 |
3.7 |
4.1 |
3.8 |
4.1 |
4.2 |
4.2 |
3.9 |
3.9 |
mg/dl |
Glucose Hx. |
201 |
202 |
199 |
213 |
205 |
214 |
202 |
202 |
206 |
211 |
mg/dl |
Glucose Ox. |
205 |
---- |
---- |
---- |
198 |
---- |
205 |
---- |
205 |
---- |
mg/dl |
Iron |
---- |
---- |
208 |
202 |
---- |
202 |
210 |
210 |
214 |
---- |
ug/dl |
Magnesium |
3.5 |
3.1 |
3.3 |
3.4 |
3.4 |
3.5 |
3.4 |
3.4 |
3.5 |
---- |
mg/dl |
Phosphorus |
4.9 |
4.8 |
5.1 |
5.3 |
4.9 |
5.1 |
4.4 |
4.4 |
5.1 |
4.8 |
mg/dl |
Total Protein |
6.4 |
6.3 |
6.3 |
6.1 |
6.9 |
6.3 |
5.9 |
5.9 |
6.1 |
6.2 |
g/dl |
Trig.-GPO |
100 |
129 |
107 |
108 |
115 |
124 |
105 |
105 |
105 |
110 |
mg/dl |
Uric Acid |
8.1 |
8.1 |
---- |
6.9 |
---- |
---- |
---- |
---- |
---- |
---- |
mg/dl |
Uric Acid Liq |
---- |
8.2 |
7.6 |
8.0 |
8.1 |
7.7 |
7.2 |
7.2 |
8.1 |
8.1 |
mg/dl |
Manufactured for Pointe Scientific, Inc.
5449 Research Drive Canton, MI 48188
"European Authorized Representative"
(O.E.A.R.C.) Av. De Tervueren 34 bte
44 B-1040 Brussels, Belgium
 |
Rev.7-06 P803-C7506-01
|
