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Products

NT-proBNP Test
NT-proBNP Whole Blood Cassette

Catalog No.         Product Name          

ABT-CT-B111        NT-proBNP Whole Blood Cassette


INTENDED USE

ACCU-TELL® Rapid NT-proBNP 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).

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid NT-proBNP 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® Rapid NT-proBNP 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

Method

CLIA

Total Results

ACCU-TELL® Rapid NT-proBNP Test Cassette

Result

Positive

Negative

Positive

21

1

22

Negative

0

310

310

Total Results

21

311

332

SensitivityAgreement:

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® Rapid NT-proBNP 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® Rapid NT-proBNP Test Cassette (Whole Blood/ Serum/Plasma) to be tested by 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® Rapid NT-proBNP 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® Rapid NT-proBNP 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® Rapid NT-proBNP 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 .