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Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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Cardiac Myoglobin Uncut Sheet Rapid Test ISO13485 Rtk Blood Test

Hangzhou Aichek Medical Technology Co.,Ltd
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Cardiac Myoglobin Uncut Sheet Rapid Test ISO13485 Rtk Blood Test

Brand Name : Aichek

Model Number : MYO-A01

Certification : CE

Place of Origin : China

MOQ : 5000 Test

Price : negotiable

Payment Terms : T/T

Supply Ability : negotiable

Packaging Details : 40box/carton

Storage : 2℃-30℃

Sample Type : Blood

User : Professional

Accuracy : 98.1% (96.3%-99.2%)

Certificate : CE ISO 13485

OEM : OEM customized packing avaliable

Formats : 25T/box 1T/box

After-sales Service : Available

Key words : Cardiac Myoglobin Rapid One Step Test uncut sheet

Combo Device : available

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Cardiac Myoglobin Rapid One Step Test with CE certificate uncut sheet

Product Name

Cardiac Myoglobin One Step Test

Formats Strip(3mm)Device(4mm) uncut sheet
Place of Origen China
Specimen Blood
Read Time 15 minutes
Shelf life 2 years
Package uncut sheet
Storage 2℃-30℃

For professional in vitro diagnostic use only.

INTENDED USE

The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

Sensitivity and Specificity

The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial Myoglobin EIA test using clinical specimens. The results show that the sensitivity of the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is 100% and the specificity is 97.8% relative to the leading EIA test.

Myoglobin Rapid Test vs. EIA

Method EIA

Total

Results

Myoglobin Rapid Test Results Positive Negative
Positive 59 8 67
Negative 0 356 356
Total Results 59 364 423

Relative Sensitivity: 100% (94.0%-100%)*

Relative Specificity: 97.8% (95.7%-99.0%)*

Accuracy: 98.1% (96.3%-99.2%)* 95% Confidence Interval

Precision

Intra-Assay

Within-run precision has been determined by using replicates of 10 tests for each of three lots using Myoglobin specimen levels at 0 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL, and 400 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, 50ng/mL, 100 ng/mL, 200 ng/mL, and 400 ng/mL of Myoglobin. Three different lots of the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/ Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Interfering Substances

The Myoglobin 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 MYO Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) and no interference was observed.

Acetaminophen Creatine Metoprolol Tartrate
Acetoacetic Acid Diclofenac Moracizine Hydrochloride
Acetylsalicylic acid Digoxin Nifedipine
Anisodamine DL-Tyrosine Oxalic Acid
Ascorbic Acid Ethanol Oxazepam
Atenolol Felodipine Pentoxifyline
Atorvastatin Calcium Flunarizine Hydrochloride Phenobarbital
Caffeine Furosemide Quinine
Captopril Gentisic Acid Ramipril
Chloramphanicol Hydrochlorothiazide Verapamil
Chlordiazepoxide Isosorbide Mononitrate
Cilazapril Labetalol


Product Tags:

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