Cardiac CK-MB Rapid One Step Test with CE certificate Uncut sheet

For professional in vitro diagnostic use only.

INTENDED USE

The CK-MB Rapid Test Device (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).

PRINCIPLE

The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of CK-MB in whole blood, serum or plasma. The membrane is pre-coated with capture reagent on the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-CK-MB antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with capture reagent on the membrane and generate a colored line. The presence of this colored line in the 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.

Sensitivity and Specificity

The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial CK-MB EIA test using clinical specimens. The results show that the sensitivity of the CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is 100% and the specificity is 99.8% relative to the leading EIA test.

CK-MB Rapid Test vs. EIA

Relative Sensitivity: 100% (93.5%-100.0%) *

Relative Specificity: 99.8% (98.7%-99.9%)*

Accuracy: 99.8%(98.9% to 99.9%)* 95% Confidence Interval

PRECISION

Intra-Assay

Within-run precision has been determined by using replicates of 10 tests for each of three lots using 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, 10 ng/mL, 20 ng/mL, and 40 ng/mL of CK-MB. Three different lots of the CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-Reactivity

Sera containing known amounts of antibodies to CK-MB have been tested with 1,390 ng/mL CKMM and 1,000 ng/mL CK-BB. No cross-reactivity was observed, indicating that the CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) has a high degree of specificity for CK-MB.

Interfering Substances

The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) has been tested and no interference was observed in specimens containing 110 mg/mL human albumin, 6 mg/mL bilirubin, 10 mg/mL hemoglobin, 5 mg/mL cholesterol and 15 mg/mL triglycerides.

The following compounds have also been tested using the CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) and no interference was observed.