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Myoglobin/CK-MB/TroponinI Test
Myoglobin/CK-MB/Troponin I Combo Whole Blood Test Cassette

Catalog No.      Product Name          

ABT-CT-E71         Myoglobin/CK-MB/Troponin I Combo Whole Blood Test Cassette  

 

INTENDED USE

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

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid Myoglobin/CK-MB/Troponin I Combo Test Cassette (Whole Blood/Serum/ Plasma) has been evaluated with a leading commercial Myoglobin/CK-MB/cTnI EIA test using clinical specimens. The results show that relative to leading EIA tests, ACCU-TELL® Rapid Myoglobin/CK-MB/Troponin I Combo Test Cassette (Whole Blood/Serum/ Plasma) shows >99.9% sensitivity and 97.8% specificity for Myoglobin, >99.9% sensitivity and 99.6% specificity for CK-MB, and 98.8% sensitivity and 98.9% specificity for cardiac Troponin I(cTnI).

Myoglobin Rapid Test vs. EIA

Method

EIA

Total Results

Myoglobin Rapid Test Cassette

Results

Positive

negative

Positive

104

15

119

Negative

0

651

651

Total Results

104

666

770

Relative sensitivity: 104/104=>99.9% (95%CI*: 97.2%~100.0%);

Relative specificity: 651/666=97.7% (95%CI*: 96.3%~98.7%);

Accuracy: 755/770=98.1 %( 95%CI*: 96.8%~98.9%). *Confidence Intervals 

CK-MB Rapid Test vs. EIA

Method

EIA

Total Results

CK-MB Rapid Test Cassette

Results

Positive

negative

Positive

77

3

80

Negative

0

690

690

Total Results

77

693

770

Relative sensitivity: 77/77=>99.9% (95%CI*: 96.2%~100.0%);

Relative specificity: 690/693=99.6% (95%CI*: 98.7%~99.9%);

Accuracy: 767/770=99.6% (95%CI*: 98.9%~99.9%).        

 *Confidence Intervals

Cardiac Troponin I Rapid Test vs. EIA

Method

EIA

Total Results

Cardiac Troponin IcTnI Rapid Test Cassette

Results

Positive

negative

Positive

158

7

165

Negative

2

603

605

Total Results

160

610

770

Relative sensitivity: 158/160=98.8% (95%CI*: 95.6%~99.8%);  

Relative specificity: 603/610=98.9% (95%CI*: 97.7%~99.5%);

Accuracy: 761/770=98.8% (95%CI*: 97.8%~99.5%).     

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of below fifteen specimens: Myoglobin specimen levels at 0 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL and 400 ng/mL, CK-MB specimen levels at 0 ng/mL, 5 ng/mL, 10 ng/mL, 20 ng/mL and 40 ng/mL and cardiac Troponin I(cTnI) specimen levels at 0ng/mL, 1.0ng/mL, 5.0ng/mL, 10ng/mL and 20ng/mL. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 3 independent assays on the same fifteen specimens: 0ng/mL, 50ng/mL, 100ng/mL, 200ng/mL and 400ng/mL of Myoglobin, 0ng/mL, 5ng/mL, 10ng/mL, 20ng/mL, and 40ng/mL of CK-MB  and 0ng/mL, 2ng/mL,  5ng/mL, 10ng/mL and 20ng/mL of cardiac Troponin I(cTnI). Three different lots of ACCU-TELL® Rapid Myoglobin/CK-MB/Troponin I Combo Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® Rapid Myoglobin/CK-MB/Troponin I Combo Test Cassette (Whole Blood/Serum/Plasma) has been tested by 10,000ng/mL Skeletal Troponin I, 2,000ng/mL Troponin T, 20,000ng/mL Cardiac Myosin, 1,800 ng/mL CK-MM, 1,200ng/mL CK-BB, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, syphilis, anti-HIV, anti-H.pylori, MONO, anti-CMV, anti-Rubella and anti-Toxoplasmosis positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to Myoglobin,CK-MB and/or cardiac Troponin I(cTnI) negative and positive specimens, repectively.

Acetaminophen:                         20 mg/dL                                 Caffeine:                                   20 mg/dL

Acetylsalicylic Acid:                      20 mg/dL                               Gentisic Acid:                            20 mg/dL

Ascorbic Acid:                            20mg/dL                                   Albumin:                              10,500mg/dL

Creatin:                                200 mg/dL                                      Hemoglobin                           1,000 mg/dL

Bilirubin:                              1,000mg/dL                                     Oxalic Acid:                               600mg/dL

Cholesterol:                             800mg/dL                                    Triglycerides:                          1,600mg/dL

None of the substances at the concentration tested interfered in the assay.

 

LIMITATIONS

  1. ACCU-TELL® Rapid Myoglobin/CK-MB/Troponin I Combo Test Cassette Whole Blood/Serum/ Plasma) is for in vitro diagnostic use only. This test should be used for the detection of Myoglobin, CK-MB, and cardiac Troponin I(cTnI) in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Myoglobin, CK-MB and cardiac Troponin I can be determined by this qualitative test.

  2. ACCU-TELL® Rapid Myoglobin/CK-MB/Troponin I Combo Test Cassette (Whole Blood/Serum/ Plasma) will only indicate the qualitative level of Myoglobin, CK-MB and Troponin I in the specimen and should not be used as the sole criteria for the diagnosis of myocardial infarction.

  3. ACCU-TELL® Rapid Myoglobin/CK-MB/Troponin I Combo Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 50ng/mL Myoglobin,5ng/mLCK-MB and 0.5ng/mL cardiac Troponin I(cTnI) in specimens. A negative result at any time does not preclude the possibility of myocardial infarction.

  4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

  5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect expected results. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.

  6. There is a slight possibility that some whole blood specimens with very high viscosity or which have been stored for more than 2 days may not run properly on the test cassette. Repeat the test with a serum or plasma specimen from the same patient using a new test cassette.