Dengue NS1 Test Cassette

The Dengue NS1 Antigen Test is a qualitative test for the detection of dengue virus in human whole blood. This test is for in-vitro diagnostic use only.

NS1 is a highly conserved glycoprotein that is present at high concentrations in the sera of dengue. Infected patients during the early clinical phase of the disease.NS1 antigen is found from the first day up to 9 days after onset of fever in sample of primary or secondary dengue infected patients.

Features

• High accuracy over 99.4%
• Relative Sensitivity 96.7%
• Relative Specificity 99.9%
• Read results in 15 minutes

Packaging

Box of 25T, Ctn of 1000T

Dengue NS1 antigen test cassette (Serum/Plasma/Whole Blood)

INTENDED USE

Dengue antigen test cassette (whole blood) is a lateral flow immunoassay for the qualitat-

-ive detection of dengue virus antigen in hum-an serum or plasma. It is intended to be used as a screening test and as an aid in the dia-

-gnosis of infection with dengue viruses. This test provides only a preliminary test result. Therefore more specific alternative diagnosis method must be used in order to obtain a confirmation of dengue infection.

PRINCIPLE

Dengue antigen test cassette (whole blood) is designed to detect dengue virus antigen in human serum or plasma. The test cassette consists of:

1. a burgundy colored conjugate padcont-

-aining mouse anti-dengue NS1 antibody

conjugated with colloid gold (dengue antibody conjugates)

1. a nitrocellulose membrane strip containing a test line(T line) and a control line(C line). The T line is pre-coated with rabbit anti-dengue NS1 antibody, and the C line is pre-coated with goat anti-mouse IgG antibody. The antibodies to dengue antigen recognize the antigens from

all of the four serotypes of the dengue virus.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates

by capillary action across the test cassette. Dengue NS1 antigen if present in thespeci-

-men will bind to the dengue antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated rabbit anti-NS1 antibody, forming a burgundy colored T line, indicating a dengue antigen positive test result. Absence of the T line suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immuneocomplex of goat anti-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T line. Otherwise, the test result is invalid and the specimen must be retested with another device.

REAGENTS AND MATERIALS PROVIDED

1. Each kit contains 40 test devices, each sealed in a foil pouch with three items inside:
2. One cassette device.
3. One pipette dropper.
4. One desiccant.
5. Sample buffer solution (1 bottle, 5ml)
6. One package insert (instruction for use).

SPECIMEN COLLOCTION

For serum or plasma, collect blood into a container without anticoagulant. If the specimens are not immediately tested, they should be stored at 2-8℃ for not more than 3 days. Specimens may be frozen at -20℃, but should not be repeatedly frozen and thawed.

Clotted specimens or specimens with microbial contamination must not be used.

For whole blood specimen, collect fresh blood specimen just prior to using the assay. Specimens must be fresh. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

TEST PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: Fill the pipette with the specimen. Holding the dropper vertically (Reference as the below picture), dispense 1 drop (about 25 µL) of specimen into the sample well making sure that there are no air bubbles. Dilute the specimen 2times with diluent(e.g. Pipette 1 drop about 25µl of specimen into the same well and then add 1 drop about 50µl of diluent into the same well).