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Accu-Tell® NT-proBNP Rapid Test Cassette (Whole Blood/ Serum/Plasma)

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Accu-Tell® NT-proBNP 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 congestive heart failure (CHF). The minimum detection level is 450 pg/mL.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
NT-proBNP   CassetteWhole   Blood/Serum/PlasmaABT-CT-B11140T/20TCE


KEY POINTS

Detection for: Human NT-proBNP in whole blood, serum or plasma as an aid in the diagnosis of congestive heart failure (CHF).

Reading time: 10minutes

Minimum detection level: 450 pg/mL.

Relative Sensitivity: 99.9%

Relative Specificity: 99.5%

Accuracy: 99.6%

 

INTRODUCTION

Congestive Heart Failure (CHF) is described as a condition in which the heart is unable to maintain adequate circulation of blood in the tissues of the body or to pump out the venous blood returned to it by the venous circulation CHF affects nearly 17 million people worldwide. NT-proBNP, N-terminal fragment of proBNP, is cleaved from the precursor peptide proBNP. It shows close correlation with the severity of heart failure. NT-proBNP is widely recognized as a definitive marker for the diagnosis of CHF.

 

INTENDED USE

ACCU-TELL® 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 congestive heart failure (CHF). The minimum detection level is 450 pg/mL.

 

TEST PROCEDURE

NT-proBNP Rapid Test 5.JPG

Allow the test cassette, 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 from the sealed pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Place the test 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) and 1 drop of buffer (approximately 40ul) to the specimen well (S) of the test , then start the timer. See illustration above.

For Venipuncture Whole Blood specimens:

Hold the dropper vertically and transfer 3 drops of venipuncture whole blood (approximately 75μL) and 1 drop of buffer (approximately 40μL) to the specimen well (S) of the test , then start the timer. See illustration above.

For Fingerstick Whole Blood specimens:

To use a capillary tube: Fill the capillary tube and transfer approximately 75 μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration above.

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


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

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

NT-proBNP Rapid Test Cassette vs. CLIA

MethodCLIATotal   Results
ACCU-TELL® NT-proBNP   Cassette (Whole Blood/ Serum/Plasma)ResultPositiveNegative
Positive21122
Negative0310310
Total Results21311332

Sensitivity Agreement:

21/21×100%>=99.9%(95%CI:86.7%-100.0%)

Specificity Agreement:

310/(1+310)×100%=99.5%(95%Cl:97.4%-100.0%)

Accuracy:

(21+310)/(21+0+1+310)×100%=99.6%(95%Cl: 97.6%-100.0%)

Precision

Intra-Assay

Within-run precision has been determined by using replicates of 15 tests for each of three lots using NT-proBNP specimen levels at 0 pg/mL, 450 pg/mL, 1000 pg/mL, 3000 pg/mL. The specimens were correctly identified >99.9% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same four specimens:0 pg/mL, 450 pg/mL, 1000 pg/mL, 3000 pg/mL of NT-proBNP. Three different lots of ACCU-TELL® NT-proBNP Rapid Test Cassette (Whole Blood/ Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99.9% of the time.

Cross-reactivity

There was no cross reactivity for ACCU-TELL® NT-proBNP Rapid Test Cassette (Whole Blood/ Serum/Plasma) to be tested by1,000ng/ml Troponin I, HAMA, Rheumatoid Factor, EBV IgM ,HBsAg, HBsAb, HbeAg, HBeAb, HBcAb, anti-HCV, anti-HIV,anti-Syphilis, anti-H. Pylori, MONO, anti-CMV, anti-Rubella and anti-Toxoplasmosis positive specimens.

Interfering Substances

The following potentially interfering substances were added to NT-proBNP negative and positive specimens.

Acetaminophen: 20 mg/dL                Caffeine: 20 mg/dL

Acetylsalicylic Acid: 20 mg/dL           Gentisic Acid: 20 mg/dL

Ascorbic Acid: 20mg/dL                    Albumin: 10,500mg/dL

Creatin: 200 mg/dL                           Hemoglobin 1,000 mg/dL

Bilirubin: 1,000mg/dL                        Oxalic Acid: 600mg/dL

Cholesterol: 800mg/dL                     Triglycerides: 1,600mg/dL

None of the substances at the concentration tested interfered in the assay.

 

LIMITATIONS

1. ACCU-TELL® NT-proBNP Rapid Test Cassette (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. ACCU-TELL® NT-proBNP Rapid Test Cassette (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. ACCU-TELL® NT-proBNP Rapid Test Cassette (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.

4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

5. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.

6. There is a slight possibility that some whole blood specimens with very high viscosity or which have been stored for more than 2 days may not run properly on the test. Repeat the test with a serum or plasma specimen from the same patient using a new test .

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.