CK‐MB Rapid Test Device
KIT COMPONENTS
● Individually packed test devices
● Disposable pipettes
● Buffer
● Package insert
●Each device contains a strip with colored conjugates ,and reactive reagents pre‐spreaded at the , corresponding regions , For adding specimens use,Phosphate buffered saline and preservative,For operation instruction.
PRECAUTIONS
- ● For professional in vitro diagnostic use only. Do not use after expiration date.
- ● The test must remain in the sealed pouch until use.
- ● Do not eat, drink or smoke in the area where the specimens or kits are handled.
- ● Do not use if pouch is damaged.
- ● Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
- ● Wear protective clothing such as laboratory coats, disposable gloves or eye protection when specimens are being tested.
- ● Humidity and temperature can adversely affect results.
EXPECTED VALIES
The CK‐MB Rapid Test Device (Whole Blood/Serum/Plasma) has been compared with a leading commercial CK‐MB EIA test, demonstrating an overall accuracy of 99.8%.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
The CK‐MB Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial CK‐ MB EIA test using clinical specimens. The results show that the sensitivity of the CK‐MB Rapid Test Device (Whole Blood/Serum/Plasma) is 100% and the specificity is 99.8% relative to the leading EIA test.
CK‐MB Rapid Test vs. EIA
|
Method |
EIA |
Total Results |
||
|
CK‐MB Rapid Test |
Results |
Positive |
Negative |
|
|
Positive |
55 |
1 |
56 |
|
|
Negative |
0 |
425 |
425 |
|
|
Total Results |
54 |
426 |
481 |
|
Relative Sensitivity: 100% (99.7%‐100.0%) *
Relative Specificity: 99.8% (99.3%‐100%)*
Accuracy: 99.8%(99.4%-100%)* 95% Confidence Interval