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

Product Description

CATALOG

KEY POINTS

Detection for: CK-MB 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: =>99.9% (95%CI*: 96.2%~100.0%);

Relative specificity: 99.6% (95%CI*: 98.7%~99.9%);

Accuracy: 99.6% (95%CI*: 98.9%~99.9%).

INTRODUCTION

Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa. Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B” which combine to form three different isoenzymes, CK-MM, CK-BB, and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.

INTENDED USE

ACCU-TELL^® CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human CK-MB 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 (approximately50μL) 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.

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

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: (77+690)/(77+3+690)=99.6%(95%CI*: 98.9%~99.9%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of below five specimens: CK-MB specimen levels at 0 ng/mL, 5 ng/mL, 10 ng/mL, 20 ng/mL and 40 ng/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 five specimens: 0ng/mL, 5ng/mL, 10ng/mL, 20ng/mL, and 40ng/mL of CK-MB. Three different lots of ACCU-TELL^® CK-MB 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^® CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by 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 CK-MB negative and positive specimens respectively.

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

Bilirubin:               1,000mg/dL                                 Acetylsalicylic Acid:  20 mg/dL

Creatin:                  200 mg/dL                                 Oxalic Acid:             600mg/dL

Gentisic Acid:          20 mg/dL                                  Ascorbic Acid:            20mg/dL

Cholesterol:            800mg/dL                                  Hemoglobin:         1,000 mg/dL

Albumin:            10,500mg/dL                                  Triglycerides:         1,600mg/dL

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

LIMITATIONS

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

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

3. ACCU-TELL^® CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 5ng/mL CK-MB 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.