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Troponin I cTnI FIA One Step Rapid Test Kit

Troponin I cTnI FIA One Step Rapid Test Kit

NGAL Troponin I Kit

Human Troponin I Kit

FIA One Step Rapid Test Kit

Place of Origin:

CN

Brand Name:

WWHS

Certification:

CE

Model Number:

NGAL

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Product Details
Product Name:
CTnI Rapid Quantitative Test Kit
Type:
One Step Assay
Reactivity:
Human
Formal Name:
Cardiac Troponin I Rapid Test Kit
Package:
25 Tests
Storage:
4-30℃
Manufacturer:
WWHS Biotech INC
Advantage:
High Sensitivity, High Accuracy
Application In:
WWHS NIR-1000 Dry Fluoroimmunoassay Analyser
Supply Ability:
10 Million A Year
Usage:
Cardiac Detection
Keywords:
High Stability, High Sensitivity, High Accuracy
Payment & Shipping Terms
Minimum Order Quantity
1000
Price
Negotiable
Packaging Details
Colorful Paper Box
Delivery Time
7 Days
Payment Terms
T/T
Supply Ability
20000 Kits per Week
Product Description

[Product Name]

Cardiac Troponin I (cTnI) Rapid Quantitative Test(Fluorescence immunoassay)


[Packing Specification]

25 Tests/kit


The kit uses immunochromatographic assay. First, cTnI antigen in the sample combines with the fluorescently-labeled cTnI monoclonal antibody conjugate. Then, it continues to move and combines with another cTnI monoclonal antibody fixed on the nitrocellulose membrane to form double-antibody sandwich immune complex in the position of the nitrocellulose membrane test line and analyze and obtain quantitative test result using NIR-1000 dry fluoroimmunoassay analyser.


[Main Ingredients]

Name Loading capacity Ingredient
Test card 25 The product consists of fluorescent mat (coated with fluorescently-labeled cTnI monoclonal murine antibody), nitrocellulose membrane (coated with cTnI monoclonal murine antibody and goat anti mouse IgG antibody), absorbent paper and bottom lining.
Sample diluent 25 Phosphate buffer
ID card 1 Record standard curve information of this batch of reagents

Ingredients of kits of different batch numbers cannot be exchanged.


[Storage Conditions and Validity]

The product should be stored at 4℃-30℃ in a dry and dark place, sealed using aluminum foil bag and must not be frozen. The storage life is 12 months. The test card should be unpacked at room temperature (15℃-30℃) and should be used in 15min after unpacked at a temperature of (15-30)℃ and relative humidity of 20%-90%.

See outer packing for production date, batch number and expiry date.

[Applicable Instrument]

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

 

[Reference Interval]

Determine 252 healthy people aged 18-68 and carry out statistical analysis using 95th percentile method. Result shows that cTnI reference interval<0.3ng/mL.

The laboratory should establish a reference range according to characteristics of local people.

[Interpretation of Test Results]

1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.

2. For samples whose cTnI concentration is lower than 0.1ng/mL and higher than 40ng/mL, test result is “<0.1ng/mL” and “>40ng/mL” respectively.

[Limitation of Test Method]

1. The kit can be used to test serum/plasma/whole blood specimens of human body only.

2. Due to limitations of serological methods for antigen and antibody response, the test result cannot be used as the only basis for clinical diagnosis and should be evaluated together with all existing clinical and experimental data.

3. The content of triglyceride contained in the sample is no more than 15mg/mL, that of hemoglobin is no more than 5mg/mL and that of hemoglobin is no more than 0.5mg/mL, and the relative deviation is limited to ±15%.

4. When cTnI concentration of samples is less than 250ng/mL, Hook effect is not observed.

  1. When human anti mouse concentration of samples is less than 50ng/mL, HAMA effect will not be observed.
  2. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±15%.

[Product Performance Indicators]

  1. Limit of detection

No more than 0.1ng/mL.

  1. Accuracy

The relative deviation to the target value is limited to ±15%.

  1. Precision

Within-run precision CV≤15%; between-run relative limit R≤15%.

  1. Linearity range

Within the specified linearity range cTnI (0.1-40) ng/mL, linearly dependent coefficient r≥0.990.

  1. Analytical Specificity

Determine cardiac troponin T, cardiac troponin C and skeletal muscle troponin I samples whose concentration is 1000ng/mL and the result does not exceed 0.1ng/mL.

[Precautions]

  1. Test card and buffer solution are single-use and they cannot be reused.
  2. Please inspect packaging integrity and validity of kit before use and then unpack the product. If the product is stored at low temperature, restore to room temperature (15℃-30℃) before unpacking and use. Reagent cannot be used if packaging is damaged and the validity period expires.
  3. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
  4. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
  5. The kit contains products from animals. Eligible information about animal source and sanitary condition cannot absolutely ensure inexistence of infectious pathogen. Therefore, these products should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
  6. Too high or too low hematocrit of red cells may affect whole blood test result, so verification should be conducted using other methods .

 

 

 

 

Notice

 

1) The test card can be used only once at room temperature, do not reuse or use test card out of expiry date.

2) Return all reagents and sample into room temperature before use.

3) Be careful when prepare sample, wear glove and mask.

4) The whole blood need add anticoagulants, not frozen; serum sample can store in frozen, avoid repeated freezing and thawing.

5) This product is only for in vitro rapid diagnostic human use, can be quantified, not only qualitative testing.

 

FAQ


Q: What's the minimum order quantity (MOQ)?
A: For most of our medical products, even order for only one unit is warmly welcomed.

 

Q: Can you do OEM/ private label?
A: Of course we can do OEM/private label for you.

 

Q: How about your delivery time?
A: 2~10 day depends your order quantity.

 

Q: What is your terms of delivery?
A: DHL, UPS, FedEx, TNT, EMS, customer's freight forwarder is also available.

 

Q: What is your terms of payment?
A: Trade Assurance, T/T in advance, L/C, Western union, paypal

Please suggest your preferred payment method.

 

Q: Do you have certification?

A: ISO13485, CE

 

Q: Do you test all your goods before delivery?

A: Yes, we have 100% test before delivery

 

Q:How about after-sale serive?

A:We will send you any parts within 15 months warranty, and supply you technology support for long time, solve problem as soon as possible .

Send your inquiry directly to us

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