Swine Flu Detection Kit
NAME AND INTENDED USE
BIOTEST Flu
A Rapid Test Kit (Colloidal Gold Immunochromatographic Strip Assay) is to be used for detection of Flu A virus (including the subtype H1N1) in nasal cavity secretion. The assay will recognize a variety of subtype of Flu A virus. It is intended to aid in the rapid diagnosis of Flu A viral infection.
For in vitro diagnostic only.
SUMMARY AND EXPLANATION OF THE TEST
Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the
respiratory tract. Only influenza A viruses are further classified by subtype on the basis of the two main surface glycoproteins hemagglutinin (HA) and neuraminidase (NA). Subtypes of influenza A that are currently circulating among people worldwide include H1N1, H1N2, and H3N2 viruses. BIOTEST Flu A Rapid Test Kit is a point-of-care test to aid in the diagnosis of infection A type influenza.
The Flu A Rapid Test Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect Flu A virus nucleoprotein antigens in specimens. The patient specimen is placed in the Extraction Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the specimen in the Extraction Tube will react with the reagents(buffer) in the Test Kit. If the extracted specimen contains Flu A antigens, two lines appear indicating a positive result. Only control line appear indicate negative.
MATERIALS PROVIDED
One package insert
One kit contents:
1. Test strip (15 pcs)
2. Sterile swab (15 pcs)
3. Pipette (15 pcs)
4. Extraction Buffer(1 vial 5ml)
5. Extraction Tube (15 pcs)
6. Tube rack (1 pcs)
MATERIALS REQUIRED BUT NOT PROVIDED Timer
WARNING AND PRECAUTIONS
v The test for in vitro diagnostic only.
v Wear protection glove before testing.
v Discard the test after use, and dispose the waste carefully.
v Do not use the kit if the pounch not in sealed.
v Do not use the kit beyond its expiration date.
v All items are single use except for extraction buffer.
v All specimens should be treated after test.
v The test strip must keep in sealed before use.
v Reading test results less than 15 minutes or later than 15 minutes after the start of the test may give erroneous results.
TEST STORAGE
Store at room temperature (4℃ ~ 30℃), out of direct sunlight, moisture and heat. Do not freeze.
SHELF LIFE
18 months
QUALITY CONTROL
A control line in the Control Zone indicates a valid result. A valid result indicates a suitable sample was collected and the test functioned properly. The control line will appear on all valid tests, whether or not the result is reactive. (Refer to Test Results ). The controls are used to verify proper test performance. Both Positive and Negative Controls should be run by each operator at the beginning of each shift during which an unknown specimen is tested. The Positive Control should be run to provide an alignment guide to indicate the location of the Control and Test Zones on the assay test strip.
TEST RESULT
POSITIVE - Two lins appear.
NEGATIVE - Only the control line appear.
INVALID - No line appear or only the test line appear.