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.

Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products.

With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of abuse, our research and development team continues to grow.

Based in Hangzhou, the company has long-term cooperation with various R&D institutions in greater China, the United States and Europe, offering the strongest technical support for the development of the company.

We are also a certified ISO and CE organization. By employing strict quality control system, our management team assures exceptional customer service and high quality products.