CE Dengue Antigen DEN NS1 Rapid Test Kit Cassette For Whole Blood Serum Plasma

CE Dengue Antigen DEN NS1 Rapid Test Kit Cassette For Whole Blood Serum Plasma

【INTENDED USE】
The Dengue NS1 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.

【INTRODUCTION】
The Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that
utilizes a combination of Dengue antibodies coated colored particles for the detection of
Dengue NS1 antigen in human whole blood, serum, or plasma.

【SPECIMEN COLLECTION AND PREPARATION】
The Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood, serum, or plasma.
 

To collect Fingerstick Whole Blood specimens:

Wash the patient’s hand with soap and warm water or clean with an alcohol swab.
Allow to dry.

• Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
• Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
• Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
• Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:                                                                                      1,Touch the end of the capillary tube to the blood until filled to approximately 75uL. Avoid air bubbles.                                         2,Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the    whole blood to the specimen            area of the test cassette.
•  Add the Fingerstick Whole Blood specimen to the test by using hanging drops:  Position the patient’s finger so that the drop of  blood is just above the specimen area of the test cassette.
•  Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen area on the test cassette, or move the patient’s finger so that the hanging drop touches the center of the specimen area. Avoid touching the finger directly to the specimen area.
• Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
• Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C.
• 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.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozenand thawed repeatedly.
• If specimens are to be shipped, they should be packed in compliance with federal regulations for transportation of etiologic agents.

【MATERIALS 】

• Materials provided
• Test cassettes
• Droppers
• Buffer
• Package insert

Materials required but not provided

• Specimen collection containers
• Centrifuge (for plasma only)
• Micropipette
• Timer

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C)
prior to testing.
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 75μL) 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.
 

To use hanging drops:

Allow 3 hanging drops of fingerstick whole blood specimen
(approximately 75 μL) to fall into 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.

【INTERPRETATION OF RESULTS】
(Please refer to the illustration above)
POSITIVE: * Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the test region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Dengue NS1 antigen present in the specimen. Therefore, any shade of red in the test region should be considered positive.

NEGATIVE: One color line appears in the control region (C). No apparent red or pink line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

【TECHNICAL DATA】
Sensitivity: 95%
Sensitivity: 95.5%
Accuracy: 96%

【Manufactured by】

DEWEI MEDICAL EQUIPMENT CO.,LTD
5th floor, No. 4 building, Shiyou Industrial Park, Jun'an , Shunde, Foshan, China 52832