Accu-Tell^® Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: Myoglobin,CK-MB and cardiac Troponin I(cTnI) qualitatively in whole blood, serum or plasma.

Specimen volume: Serum or Plasma Specimen: 50μL

                                 Venipuncture or Fingerstick Whole Blood Specimen: 75μL

Reading time: 10 minutes

Relative sensitivity and specificity: Please refer to the performance characteristics

INTRODUCTION

ACCU-TELL^® Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated particles and capture reagents to qualitatively detect Myoglobin, CK-MB and cardiac Troponin I(cTnI) in whole blood, serum or plasma. The minimum detection level is 50 ng/mL Myoglobin, 5 ng/mL CK-MB and 0.5 ng/mL Troponin I.

INTENDED USE

ACCU-TELL^® Myoglobin/CK-MB/Troponin I Combo Rapid 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).

TEST PROCEDURE

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50μL) to the specimen area, then add 1 drops of buffer (approximately 40μL), and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75μL) to the specimen area, then add 1 drops of buffer (approximately 40μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 75μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 10 minutes.  Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL^® Myoglobin/CK-MB/Troponin I Combo Rapid 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^® Myoglobin/CK-MB/Troponin I Combo Rapid 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

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

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

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, 1ng/mL,  5ng/mL, 10ng/mL and 20ng/mL of cardiac Troponin I(cTnI). Three different lots of ACCU-TELL^® Myoglobin/CK-MB/Troponin I Combo Rapid 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^® Myoglobin/CK-MB/Troponin I Combo Rapid 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, Rheumatoid Factor(RF), HAMA, HCV, 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^® Myoglobin/CK-MB/Troponin I Combo Rapid 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^® Myoglobin/CK-MB/Troponin I Combo Rapid 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^® Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 50ng/mL Myoglobin,5ng/mL CK-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. 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.