Accu-Tell^® Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: NS1 antigen of dengue virus in human whole blood, serum or plasma.

Specimen volume: Serum or Plasma Specimen: 75μL

                                    Venipuncture or Fingerstick Whole Blood Specimen: 75μL

Reading time: 10 minutes

Relative sensitivity: 95.8% (95%CI*: 88.3%~99.1%);  

Relative specificity: 96.2% (95%CI*: 90.6%~99.0%);

Accuracy: 96.1% (95%CI*:92.1%~98.4%)

INTRODUCTION

Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world, and causes up to 100 million infections annually. Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash.

INTENDED USE

ACCU-TELL^® Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of NS1 antigen of Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of Dengue infections.

TEST PROCEDURE

1.  Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within 1 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 μL) to the specimen area, and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 μL) to the specimen area, then add 1 drops of buffer (approximately 40 μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

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 below.

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

 PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL^® Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) has passed a seroconversion panel and compared with a leading commercial Dengue Ag EIA test using clinical specimens.

The results show that the relative sensitivity of ACCU-TELL^® Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) is 95.8%, and the relative specificity is 96.2%.

Relative specificity: 102/106*100%=96.2% (95%CI*: 90.6%~99.0%);

Accuracy: (69+102)/(69+3+4+102)*100%=96.1%(95%CI*:92.1%~98.4%)

*Confidence Intervals

LIMITATIONS

1.  The Assay Procedure and the Assay Result Interpretation must be followed closely when testing the presence of dengue Ag in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

2.  ACCU-TELL^® Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) is limited to the qualitative detection of dengue Ag in human whole blood, serum or plasma. The intensity of the test band does not linear correlate with dengue Ag titer of the specimen.

3.  A negative test result does not preclude the possibility of exposure to or infection with dengue viruses.

4.  A negative result can occur if the quantity of dengue Ag present in the specimen is below the detection limits of the assay, or the dengue Ag that are detected are not present during the stage of disease in which a sample is collected.

5.  Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

6.  If the symptom persists, while the result from Dengue NS1 Rapid Test is negative or non-reactive result, it is recommended to re-sample the patient few days late or test with an alternative test device such as PCR, ELISA.

7.  The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

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