Product Overview

Description

  Blood testing kit Syphilis TP rapid test

 

 

 

 

Product Description

INTENDED USE

Treponema pallidum is syphilis pathogen which is sexually transmitted diseases of more serious danger. The treponema pallidum was invasion of skin and mucosa in prophase and mainly to violations of the cardiovascular and nervous system in advanced stage. It not only causes systemic damage, but also can cause of congenital syphilis through the placenta to the fetus at the same time. The kit is use for qualitative detection the may exist teponema pallidum antibody in the pre-test sample of serum or plasma and as auxiliary diagnostic method for syphilis infection in clinical diagnosis. Treponema pallidum is syphilis pathogen which is sexually transmitted diseases of more serious danger. The treponema pallidum was invasion of skin and mucosa in prophase and mainly to violations of the cardiovascular and nervous system in advanced stage. It not only causes systemic damage, but also can cause of congenital syphilis through the placenta to the fetus at the same time. The kit is use for qualitative detection the may exist teponema pallidum antibody in the pre-test sample of serum or plasma and as auxiliary diagnostic method for syphilis infection in clinical diagnosis.

 

MATERIALS PROVIDED

1. Test Cassette: 40 test cards/ box, nitrocellulose membrane (the test line is coated with the syphilis antigen and the control line is coated with Rabbit anti TP antibody) conjugate pad (adhere the recombinant antigen colloidal gold-labeled)

2.  Product instruction:1

 

Principle of the test

This kit was adopting the immunochromatography double antigen sandwich method: coat the recombinant TP antigen on the test line of cellulose nitrate film, coat the rabbit anti TP antibody on the control line and immobilize the colloidal gold labeled recombinant TP antigen on the conjugate pad. The TP antibody of sample can be combined to form complex with colloidal gold labeled recombinant TP antigen on the pad, and under the action of moving along the membrane by chromatography when detection of positive samples. It can condense color in the detection line when the pre-coat TP antigen catches part of the complexes. The other free gold labeled TP antigen complex is binding with the rabbit anti TP antibody coated in the control line and coloration. Negative samples are only coloration in the control line.

 

SAMPLE REQUEST

Serum samples were collected from venous blood by conventional method. Plasma samples can be deal with heparin, sodium citrate, EDTA. Samples can be stored at 4 °C if tests will be done within 5 days, otherwise stored at -20 °C. Samples with hemolysis cannot be used.

 

TEST PROCEDURE:

1. Test preparation: micropipettes (100μL) and kinds of supporting tip or dropper (100μL).

2. Test process: Place the test card on a dry horizontal work surface.

Using a micropipette to added 100μL (approximately 2 drops) serum or plasma of sample into the sample well of detecting card and to observe the results in 15-20 minutes.

3. Test process matters needing attention:

a. The temperature of the kit and the test sample should be the same with room temperature before test.

b. the test card must be used within 30 minutes after unsealing.

c. The observation is invalid after 25 minutes.

 

INTERPRETATION OF RESULTS

Positive:     Two pink lines appear in both C and T position

Negative:    Only one pink line appear in C position

Invalid:      The control line next to the test line does not become visible within 30 minutes after the addition of the sample.

 

STORAGE AND STABILITY

The Rapid Test can be stored at any temperaturebetween 4-30°C.Do not freeze. The stability of the kit under these storageconditions is 24 months. Use up the reagents as soon as possible after the kit is unpacked.

 

Matters needing attention

 

1. It needs other methods to confirmation when the kit test result is positive.

 

2. To avoid the test card exposing in the air for long time since it can absorb moisture and affect the test results.

 

3. The degree of coloration on the test line do not inherently connected to the antibody titers in test sample.

 

4. If the pre-diluted specimens may detect false positive results, Also contamination, severe hemolysis (above 5g / L), jaundice (above 40μmol / L) or lipids (higher than 3.72mmol / L) can cause error result. It should be re-sampling and tested.

 

5. The color of C line is likely to abate when the content of the treponema pallidum antibody is extremely high in the sample. It is a normal phenomenon.

 

Our Services

  

1. Samples: we offer free samples

2. OEM services: we accept customized services

3. If you have any other questions or requests, pls. feel free to contact Bioneovan at any times.

 

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