NAME AND INTENDED USE

FluTest^® 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.

 
>>back to top<<

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. FluTest^® A, Rapid Test Kit is a point-of-care test to aid in the diagnosis of infection A type influenza. 
 

>>back to top<<

BIOLOGICAL PRINCIPLES OF THE TEST

The FluTest^® 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 Buffer Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. The specimen in the Buffer Tube will react with the reagents 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. If only one line appears, it indicates a negative result.

 
>>back to top<<

MATERIALS PROVIDED

One package insert
One kit contents:
1. Test strip (1 pc) 
2. Sterile swab (1 pc)
3. Pipette (1 pc) 
4. Buffer tube (1 vial)

>>back to top<<

MATERIALS REQUIRED BUT NOT PROVIDED

Timer

>>back to top<<

WARNING AND PRECAUTIONS

• The test for in vitro diagnostic only.

• Wear protection glove before testing.  

• Discard the test after use, and dispose the  waste carefully

• Do not use the kit if the pouch is not sealed.

• Do not use the kit beyond its expiration date.

• All items are for single use only.

• All specimens should be treated properly. 

• The test strip must keept  sealed until usage.

• Reading test results in less than 10 minutes or  beyond 15 minutes after the start of the test may give erroneous results.

>>back to top<<

TEST STORAGE 

Store at room temperature (4°C ~ 30°C), out of  direct sunlight, moisture and heat. Do not freeze.

 

>>back to top<<

SHELF LIFE

18 months

 


>>back to top<<

QUALITY CONTROL

A test line in the Test Zone indicates a valid result.  A valid result indicates a suitable sample was collected and the test functioned properly. The test 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.

>>back to top<<

TEST RESULT 



 
POSITIVE - Two lines appear. Please consult your doctor for further medical evaluation and  action.
NEGATIVE - Only the control line appears.
INVALID - No line appear or only the test line appear

>>back to top<<

C. Squeeze  both sides of tube against swab to release as much liquid as possible from the swab

D. Using the pipette add 4~5 drops of liquid from the tube on to the sample window and read the results within 10~15 minutes

>>back to top<<

CLINICAL PERFORMANCE




The lowest detectable limit
For influenza type A : 1.0×103TCID50/0.1ml
A total of 383 influenza-like symptoms comparison with another brand influenza test.

Sensitivity of FluTest^® A for influenza A: 95/103x100%=92.23%
Specificity of FluTest^® A for influenza A: 267/280x100%=95.34%

 



>>back to top<<

ANALYTICAL SPECIFICITY

FluTest^® A, can detect the below influenza A  viral strains. All showed positive results. Although the specific influenza strains causing infection in humans can vary year to year, all contain the conserved nucleoproteins targeted by FluTest^® A Test Kit.

>>back to top<<

CROSS-REACTIVITY

FluTest^® A  Kit was evaluated with a total of 15 bacterial and viral isolates. None of the organisms or viruses listed below gave a positive result with the test kit.
Respiratory Syncytial Virus
Parainfluenza Virus 3
Adenovirus 7
Coxsackievirus A16
Herpes Simplex Virus
Rhinovirus
Mycoplasma pneumoniae
Mycobacterium tuberculosis
Parainfluenza Virus 1
Adenovirus 3
Echovirus
Poliomyelitis Virus
Mumps Virus
Influenza C Virus
Chlamydia pneumoniae

>>back to top<<

Keep out of the reach and sight of children.