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Products

D-Dimer Test
D-Dimer Whole Blood Test Cassette

Catalog No.        Product Name                 

ABT-CT-B110     D-Dimer Whole Blood Test Cassette


INTENDED USE

ACCU-TELL® Rapid D-Dimer Test Cassette(whole blood/plasma/serum) is a rapid chromatographic immunoassay for the qualitative detection of D-Dimerto aid in the diagnosis of deep vein thrombosis(DVT), pulmonary embolism(PE) and disseminated intravascular coagulation(DIC) .

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid D-Dimer Test Cassette(Whole Blood/Serum/Plasma) has been evaluated with specimens obtained from apparently healthy blood donor and patients specimen. The result shows that the sensitivity of ACCU-TELL® Rapid D-Dimer Test Cassette(Whole Blood/Serum/Plasma) is 97.4% and thespecificity is 98.1% relative to other Rapid Test.

Method

Other Rapid Test

Total

Result

ACCU-TELL® Rapid D-Dimer Test Cassette (Whole Blood /Serum/Plasma)

Results

Positive

Negative

Positive

76

2

78

Negative

2

101

103

Total Result

78

103

181

Relative sensitivity: 76/78=97.4% (95%CI*: 91.0%~99.7%);  

Relative specificity: 101/103=98.1% (95%CI*: 93.2%~99.8%);

Accuracy: (76+101)/(78+103) =97.8% (95%CI*: 94.4%~99.4%).     

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of below three specimens: D-Dimer specimen levels at 0μg/mL, 0.5μg/mL and 5μg/mL. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 3 independent assays on the same three specimens: 0μg/mL, 0.5μg/mLand 5μg/mL of D-Dimer. Three different lots of ACCU-TELL® Rapid D-Dimer Test Cassette(Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® Rapid D-Dimer Test Cassette(Whole Blood/Serum/Plasma) has been tested by Fibrinogen, Fibrin monomer, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, syphilis, anti-HCV, anti-HIV, anti-H.pylori positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to D-Dimer negative andpositive specimens respectively.

Acetaminophen:    20 mg/dL          Caffeine:   20 mg/dL            Bilirubin:        1,000mg/dL  Acetylsalicylic Acid:  20 mg/dL     Creatin:          200 mg/dL        Oxalic Acid:  600mg/dL

Gentisic Acid:      20 mg/dL      Ascorbic Acid:   20mg/dL     Cholesterol:       800mg/dL       Hemoglobin: 1,000 mg/dL           Albumin:       10,500mg/dL      Triglycerides:  1,600mg/dL

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

 

LIMITATIONS

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

  2. ACCU-TELL® Rapid D-Dimer Test Cassette(Whole Blood/Serum/Plasma) will only indicate the presence of D-Dimer in the specimen and should not be used as the sole criteria for the diagnosis of eep vein thrombosis(DVT), pulmonary embolism(PE) and disseminated intravascular coagulation(DIC).

  3. For confirmation, further analysis of the specimens should be performed according to local health authorities’ guidelines, such as ELISA.

  4. As with all rapid test cassettes, all results must be interpreted together with other clinical information available to the physician.

  5. This test is intended for screening purposes only.

  6. A negative result does not exclude the possibility of thrombosis. Therefore, the result obtained with  D-Dimer Rapid Test Cassette should be used in conjunction with clinical finding to make an accurate diagnosis.