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

Product Description

CATALOG

KEY POINTS

Detection for: Human cardiac Troponin I in whole blood, serum or plasma

Reading time: 10 minutes

Relative Sensitivity: 98.8%

Relative Specificity: 98.9%

Accuracy: 98.8%

INTRODUCTION

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa. Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle. After cardiac injury occurs, Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnI is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of cTnI measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma. cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic  damage  due  to coronary  artery  bypass surgery. Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction.

INTENDED USE

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

TEST PROCEDURE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.

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

For Serum or Plasma specimen:

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

For Venipuncture Whole Blood specimen:

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

For Fingerstick Whole Blood specimen:

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

4. 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^® Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial cTnI EIA test using clinical specimens. The results show that the sensitivity of ACCU-TELL^® Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is 98.8% and  the specificity is 98.9% relative to the leading EIA test.

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of five specimens: a negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive. The negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same five specimens: a negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL^® Troponin I 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, 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 cTnI negative and positive specimens.

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

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

3. ACCU-TELL^® Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 0.5ng/mL of 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.