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High Accuracy Troponin I Test Kit Rapid Chromatographic Immunoassay 98% Accuracy

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We are satisfied with your quality & services so far. The HIV 1/2 antibody Test performance is perfect.

—— Katrina

I have to say that New Life provides high quality products. The FOB, Troponin I, HIV, HCV, Drug Abuse test all performed very well in our market.

—— Clemen

Your Dengue IgG/IgM and Malaria test perfromed well. Now we want to try your Filariasis test in our market.

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High Accuracy Troponin I Test Kit Rapid Chromatographic Immunoassay 98% Accuracy

China High Accuracy Troponin I Test Kit Rapid Chromatographic Immunoassay 98% Accuracy supplier

Large Image :  High Accuracy Troponin I Test Kit Rapid Chromatographic Immunoassay 98% Accuracy

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,CE
Model Number: cassette

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 2000000pcs/month
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Detailed Product Description
Category: Cardiac Test Format: Cassette
Specimen: Whole Blood/Serum/Plasma Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: Troponin I
Accuracy: 98.9%

High accuracy One Step Troponin I Rapid Diagnostic Test, diagnosis of myocardial infarction (MI),quickly

 

 

 

Intended Use:

 

 

The Troponin I Rapid Test Device (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 Principle:

 

The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of cTnI 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-cTnI 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.

 

 

 

TEST PROCEDURE

 

1.  Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2.  Remove the device from the sealed pouch and lay it on a flat and dry surface.

3.  Using the provided pipette, add one drop of fresh specimen to the sample well.

4.  Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5.  Read the result between 15-20minutes. Do not read results after 20 minutes.

 

INTERPRETATION OF RESULTS

 

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

 

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

 

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

 

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

 

PERFORMANCE CHARACTERS:

 

 

 

Sensitivity and Specificity

 

 

The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial cTnI EIA test using clinical specimens. The results show that the sensitivity of the Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is 98.3% and the specificity is 98.4% relative to the leading EIA test.

 

 

 

Troponin I Rapid Test Device vs. EIA

 

Method EIA Test

Total

Results

Troponin I Rapid Test Device Results Positive Negative
Positive 113 6 119
Negative 2 493 495
Total Results 115 499 614

 

Relative Sensitivity: 98.3%(93.9%-99.8%)*

Relative Specificity: 98.4%(97.4%-99.6%)*

Accuracy: 98.7%(97.5%-99.4%)*

*95% Confidence Interval

 

 
ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry

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Contact Person: Jerry Meng

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