タイトルまたは説明

TP(Syphilis ) Test
For in vitro diagnostic use only
INTENDED USE:
Rapid Syphilis Antibody Test is a rapid immunochromatographic assay for the detection of antibodies to Treponema pallidum in human serum, plasma or whole blood. The assay is used as a screening test for T. Pallidum infection (also known as Syphilis).

SPECIFICATION:
1) Specimen: Whole blood/serum/plasma
2) Format: Cassette
3) Sensitivity: *9.*0%
4) Specificity: *9.*3%

FEATURE:
1) Simple: Simply add specimen and dilution(if necessary) into sample well
2) Rapid: Results come out at *5 minutes
3) Visually interpreted: Don't need any equipment
4) Stable: More than *2 month period of validity

PACKING:
Cassette: *5 tests/box, *0 tests/box

PROCEDURE:
1) Bring the kit components to room temperature before testing.
2) Open the pouch and remove the Card. Once opened, the test card must be used immediately.
3) Label the test card with patients identity.
4) Apply 3 drops (******0 μL) of serum, plasma or whole blood to the sample well marked as S.
5) At the end of *5 minutes read the results. A strong positive sample may show result earlier.

INTEPRETATION OF RESULTS
Positive:
Two colored bands appear within *5 minutes. One colored band appears in the Control Zone (C) and another colored band appears in the Test Zone (T). The test result is positive and valid. No matter how faint the colored band appears in the Test Zone (T), the test result should be considered as positive result.
Negative:
One colored bands appears in the Control Zone (C) within *5 minutes. No colored band appears in the Test Zone (T). The test result is negative and valid.
Invalid result:
No colored band appears in the Control Zone (C) within *5 minutes. The test result is invalid. Repeat the test with a new test device.

PRINCIPLE:
This Rapid anti-TP Test employs chromatographic lateral flow test device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-AG) corresponding to TP antigens (P*7, P*5, P*7, P*5) are dry-immobilized at the end of nitrocellulose membrane strip. TP antigens are bond at the Test Zone (T) and rabbit anti-TP antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, TP antibodies (anti-TP) will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by TP antigens generating a visible red line. If there are no anti-TP antibodies in sample, no red line is formed in the Test Zone (T). The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-TP aggregating in a red line, which indicates the validity of the test.