The Myoglobin/CK‐MB/Troponin I Rapid Combo Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic  immunoassay for the qualitative detection of human Myoglobin, CK‐MB and cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

PRINCIPLE

The Myoglobin/CK‐MB/Troponin I Rapid Combo Test Device (Whole Blood/Serum/ Plasma)is a qualitative, membrane based immunoassay for the detection of Myoglobin,CK‐MB and Troponin I in whole blood, serum or plasma.The membrane is pre‐coated with specific capture antibodies in each of the test line regions of the test. During testing, the whole blood,serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture  migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line.The presence  of this colored line in  the  specific  test line region indicates a  positive result, while its absence indicates a negative result. To serve as  a procedural  control,a colored line will always appear in  the  control line region  indicating that Proper volume of specimen has been added and membrane wicking has occurred.

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.

• 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