NT-proBNP Rapid Test Kit

 NT-proBNP Rapid Test Kit

1. Product Details

Product Name: The NT-proBNP Rapid Test Kit

Format: Cassette

Test Item: Human NT-proBNP

Specimen: Whole Blood/Serum/Plasma

Storage: 2-30°C

2. Principle

The NT-proBNP Rapid Test Kit (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of NT-proBNP in whole blood, serum or plasma. The membrane is pre-coated with capture reagents on the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti- NT-proBNP antibodies. The mixture migrates upward on the membrane by capillary action to react with capture reagents 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.

3. Directions for Use

Allow the test device, specimen and/or controls to reach room temperature (15-30°C) prior to testing.

(1) Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.

(2) Place the test device on a clean and level surface.

For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 µL) to the specimen well (S) of the test device, then start the timer. See illustration below.

For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 3 drops of venipuncture whole blood (approximately 75 µL) and a drop of buffer (approximately 40 µL) to the specimen well (S) of the test device, then start the timer. See illustration below.

For Fingerstick Whole Blood specimens: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 µL)  and a drop of buffer (approximately 40 µL)  to fall into the center of the specimen well (S) on the test device, then start the timer. See illustration below.

(3) Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes.

4. Limitations

(1) The NT-proBNP Rapid Test Device (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of NT-proBNP in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in NT-proBNP can be determined by this qualitative test.

(2) The NT-proBNP Rapid Test Device (Whole Blood/Serum/Plasma) will only indicate the qualitative level of NT-proBNP in the specimen and should not be used as the sole criteria for the diagnosis of congestive heart failure.

(3) The NT-proBNP Rapid Test Device (Whole Blood/Serum/Plasma) cannot detect less than 450 pg/mL of NT-proBNP in specimens. A negative result at any time does not preclude the possibility of congestive heart failure.

5. Sensitivity and Specificity

The NT-proBNP Rapid Test Kit (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial NT-proBNP EIA test using clinical specimens. The results show that the sensitivity of the NT-proBNP Rapid Test Kit (Whole Blood/Serum/Plasma) is >99.9% and the specificity is 98.8% relative to the leading EIA test.

One Step NT-proBNP Test Kit vs. EIA

Relative Sensitivity: >99.9% (92.8%-100% )                                      Relative Specificity: 98.8% (95.8%-99.9%)

Accuracy: >99.9 % (96.8%-99.9%)                                                    * 95% Confidence Interval

Hangzhou Laihe Biotech Co., Ltd

Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China

Contact: Helen

Tel: +86-571-86658003

Fax: +86-571-86658000

E-mail: office@lyher.com

Zip:310052