ANTIGEN RAPID TEST KIT

FLUORESCENE IMMUNOASSAY TEST


Also known as: Rapid diagnostic test (some molecular tests are also rapid tests.)

Sample: Nasal or throat swab

Result: 15 minutes

Is another test needed: Positive results are highly accurate. Negative results may need to be confirmed with one more test.

What it shows: Diagnoses active Coronavirus infection

Definition: An antigen is a molecule or structure present on the outside of a pathogen.


BENEFITS

  • The test provides much faster results than Molecular test (15 minutes).
  • The test detects the virus directly at early stage of the infection.
  • The test is easy to use and can be used at home (Colloidal Gold Method).
  • The sensitivity of the Colloidal Gold Test is close to 90%, specificity of test is close to 100%.
  • The sensitivity of the Fluorescence Immunoassay Test ist over 90%, specificity of test is close to 100%.
  • The production of this test is high and it can limit the spread of COVID-19 effectively.


SAMPLING COLLECTION

  1. Tip the patient‘s head back and collect sample from the nostril that has more mucus (head should be inclined from vertical for proper specimen collection).
  2. Insert the swab through the nostril entry and then slowly move along the bottom of the nasal cavity (gently to avoid traumatic bleeding).
  3. When the tip of the swab reaches the posterior wall of the nasopharyngeal cavity, gently rotate it several times (collect as much secretion as possible).
  4. To prevent reflex coughing, stop for one minute.
  5. Slowly remove the swab.
  6. Test the sample as soon as possible.


PROCEDURE

  1. Add 300 μL sample treatment solution to the tube. *
  2. Squeeze the tube and rotate the swab 10 times.
  3. Remove the swab and load the dropper lid. 
  4. Add 3 drops (about 70 μL) of sample to the sample hole, then wait for 15 minutes for a reaction (room temperature).


* If disposable plastic pipet is used to get the sample solution, repeat three times (100 μL each time) that in total 300 μL is
added to the tube.


  1. Turn on the machine. Press the [TEST] button on the screen
  2. Insert the ID chip. Press [READ ID CARD] and [TEST] button on the screen
  3. Take out the cassette and insert it into the analyzer. Press [TEST] and get the result. Press [PRINT] and print out the result from inner printer.


CLINICAL PERFORMANCE

The performance of the kit has been verified by the Centers for Disease Control and Prevention (CDC) in China using 351 clinical samples (with PCR results).


Clinical Sensitivity is 92%

Clinical Specificity is 100%


SHIPPING INFORMATION

HS-CODE 3002.1500 

25 tests / box

40 boxes / carton

1000 tests / carton


Material: corrugated paper

Size: 570 x 407 x 375 mm

Net Weight: 17,5 kg

Total Weight: 19 kg


20" Container - 144.000  test

40" Container - 288.000 test

40" HQ Container - 320.000 test


air shipment - 1000 karton - 120.000 kg net . 160.000 gross - dimension  - 58-44-45 cm - 114,84 cbm