Accu-Tell^® D-Dimer Rapid Test Cassette (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: D-Dimer in human whole blood, plasma or serum.

Specimen volume: Serum or Plasma Specimen: 25μL

Reading time: 15 minutes;

Relative sensitivity: 97.4% (95%CI*: 91.0%~99.7%);  

Relative specificity: 98.1% (95%CI*: 93.2%~99.8%);

Accuracy: 97.8% (95%CI*: 94.4%~99.4%).

INTRODUCTION

D-dimer is a biomarker that globally indicates the activation of hemostasis and fibrinolysis. It is a degradation product of fibrin, which is produced when cross-linked fibrin is degraded by plasmin-induced fibrinolytic activity.

INTENDED USE

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

TEST PROCEDURE

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 1 drop of serum or plasma (approximately 25 μL) to the specimen area, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.

For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen area, then add 1 drops of buffer (approximately 40μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen: To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drops of buffer (approximately 40μL) and start the timer. See illustration below.

3.   Wait for the purple line(s) to appear. Read results at 15 minutes.  Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

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

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/mL and 5μg/mL of D-Dimer. Three different lots of ACCU-TELL^® D-Dimer Rapid Test Cassette (whole blood/plasma/serum) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL^® D-Dimer Rapid Test Cassette (whole blood/plasma/serum) 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^® D-Dimer Rapid Test Cassette (whole blood/plasma/serum) 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^® D-Dimer Rapid Test Cassette (whole blood/plasma/serum) 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 ACCU-TELL^® D-Dimer Rapid Test Cassette (whole blood/plasma/serum)should be used in conjunction with clinical finding to make an accurate diagnosis.

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