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CE Certificated Rapid Diagnostic Test NT - proBNP Rapid Test Cassette

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Hangzhou AllTest Biotech CO.,LTD
City: Hangzhou
Province/State: Zhejiang
Country/Region: China
Tel: 86-571-85361863
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CE Certificated Rapid Diagnostic Test NT - proBNP Rapid Test Cassette

Brand Name : AllTest
Model Number : cassette
Certification : CE
Place of Origin : CHINA
MOQ : 500
Supply Ability : 100 Million a year
Packaging Details : 25 tests per kit
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A rapid test for the diagnosis of myocardial infarction (MI) to detect NT-proBNP qualitatively in whole blood, serum or plasma CE certified


Applications:


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


Description:


The N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) is a 76 amino acid N-terminal inactive protein that is cleaved from proBNP to release brain natriuretic peptide.Both BNP and NT-proBNP levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure, as both markers are typically higher in patients with worse outcome.The plasma concentrations of both BNP and NT-proBNP are also typically increased in patients with asymptomatic or symptomatic left ventricular dysfunction and is associated with coronary artery disease and myocardial ischemia.

The NT-proBNP Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-NT-proBNP antibody coated particles and capture reagents to qualitatively detect NT-proBNP in whole blood, serum or plasma. The minimum detection level is 0.45ng/mL.


How to use?


DIRECTIONS FOR USE

Allow the test, specimen, buffer 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 cassette from the sealed pouch and use it within one hour.
  2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

  • Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 mL) to the sample well of the test cassette, then start the timer immediately. See illustration below.

For Venipuncture Whole Bloodspecimen:

  • Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 mL) to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40 mL), and start the timer. See illustration below.

For Fingerstick Whole Bloodspecimen:

  • To use a capillary tube: Fill the capillary tube and transfer approximately 75 mL of fingerstick whole blood specimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.
  • To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen (approximately 75 mL) to fall into the specimen well of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.
  1. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.


INTERPRETATION OF RESULTS


(Please refer to the illustration above)

POSITIVE:* A colored line in the control line region (C) and the presence of another colored line in the test line regions indicates a positive result. This indicates that the concentration of NT-proBNP is above the minimum detection level.

*NOTE: The intensity of the color in the test line region will vary depending on the concentration of NT-proBNP, present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).This indicates that the concentration of NT-proBNP are below the minimum detection levels.

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.


QUALITY CONTROL


A procedural control is included in the test. A colored line appearing in the control line region(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.


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