Myoglobin/CK-MB/Troponin I Rapid Combo Test Device (WB/S/P)
PRINCIPLE
The Myoglobin/CK‐MB/Troponin I Rapid Combo TestDevice (WholeBlood/Serum/ Plasma)is a qualitative, membrane basedimmunoassayfor the detection of Myoglobin,CK‐MB and TroponinI in wholeblood, serumor plasma.Themembrane is pre‐coated with specific capture antibodies in each of the testlineregions of thetest.During testing,the whole blood,serum or plasma specimen reacts with the particlecoated with specific antibodies. The mixture migrates upward on the membrane chromatographicallybycapillary action toreact with specificcapturereagentson the membraneandgeneratea colored line.Thepresence of thiscolored line in the specific test lineregion indicates a positiveresult, while its absenceindicatesa negative result. To serve as a procedural control,a colored line will alwaysappear in the control line region indicating that Proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test containsanti‐Myoglobinantibodycoatedparticles,anti‐CK‐MB antibody coated particles,anti‐Troponin I antibody coatedparticles,andcapture reagents coated on themembrane.
EXPECTED VALUES
The Myoglobin/CK‐MB/Troponin I Rapid Combo Test Device (Whole Blood/Serum/ Plasma) has
been compared with a leading commercial Myoglobin/CK‐MB/T EIA test, demonstrating an overall
accuracy of 98.1% with Myoglobin, 99.8% with CK‐MB, and 98.5% with Troponin I.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
The Myoglobin/CK‐MB/Troponin I Rapid Combo Test Device (Whole Blood/Serum/ Plasma) has
been evaluated with a leading commercial Myoglobin/CK‐MB/Troponin I EIA test using clinical
specimens. The results show that relative to leading EIA tests, the Myoglobin/CK‐MB/Troponin I
Rapid Combo Test Device (Whole Blood/Serum/ Plasma) exhibits 100% sensitivity and 97.8%
specificity for Myoglobin, 100% sensitivity and 99.8% specificity for CK‐MB, and 98.3% sensitivity
and 98.6% specificity for Troponin I.
Myoglobin Test vs. EIA
Method | EIA | Total Results | ||
MYO Test | Positive Negative | Positive | Negative | |
| Positive | 59 | 8 | 67 | |
| Negative | 0 | 356 | 356 | |
Total Results | 59 | 364 | 423 | |
Relative Sensitivity: 100% (94.0%‐100%)*
Relative Specificity: 97.8% (95.7%‐99.0%)*
Accuracy: 98.1% (96.3%‐99.2%)* 95% Confidence Interval
CK‐MB Test vs. EIA
Method | EIA | Total Results | ||
CK‐MB Test | Positive Negative | Positive | Negative | |
| Positive | 55 | 1 | 56 | |
| Negative | 0 | 425 | 425 | |
Total Results | 55 | 426 | 481 | |
Relative Sensitivity: 100% (93.4%‐100.0%) *
Relative Specificity: 99.8% (98.7%‐99.9%)*
Accuracy:99.8%(98.8%‐99.9%)* * 95% Confidence Interval
Troponin I Test vs. EIA
Method | EIA | Total Results | ||
cTnI Test | Positive Negative | Positive | Negative | |
| Positive | 228 | 7 | 235 | |
| Negative | 4 | 509 | 513 | |
Total Results | 232 | 516 | 748 | |
Relative Sensitivity: 98.3%% (9(97.2%‐99.4%)*5.6%‐ 99.5%)*
Relative Specificity: 98.6% (97.2%‐99.4%)*
Accuracy: 98.5%(97.4%‐99.3%)* * 95% Confidence Interval
