Beijing Kinghawk CO.,LTD

Treponema Pallidum Antibody
 Gold Rapid Screen Test
For the qualitative detection of TP antibodies
 in serum/plasma

INTENDED USE
The Treponema Pallidum antibody Gold Rapid Screen Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Treponema Pallidum virus (TP) in human serum or plasma.

PRINCIPLE
The TP RST is a chromatographic immunoassay (CIA) for the detection of antibodies to Treponema Pallidum in human serum or plasma. TP recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with TP recombinant antigens. If antibodies to TP present, a puple colored band will develop on the membrane in proportion to the amount of TP antibodies present in the specimen. Absence of this purple colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to TP.
 STORAGEStore the test kit at temperature 4-30°C,the sealed pouch for the duration of the shelf life (12 months).
 SPECIMEN COLLECTIONPlasma
Have a certified phlebotomist collect whole blood into a collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.Separate the plasma by centrifugation.Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.
Serum
Have a certified phlebotomist collect whole blood into a collection tube (containing no anticoagulants) by veinpuncture.Allow the blood to clot.Separate the serum by centrifugation.Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.
PROCAUTION
FOR IN VITRO DIAGNOSTIC USES ONLYAll patient samples should be treated as if capable of transmitting diseases.Do not interchange reagents from different lots or use test kit beyond expiration date.
4.  Icteric, lipemic, hemolytic and contaminated sera may cause erroneous results, thus should avoid applying for these specimens.

REAGENTS AND MATERIALS PROVIDED
1.  One pouched cassette with desiccant.
2.  One piece of operating instruction.

Assay PROCEDURE
Equilibrate the kit to room temperature (15-30ºC) prior to test, the test should be completed within 20 minutes
Add 80 ul or 2-3 drops serum or plasma into sample well. Observe the result in 20 minutes. The result showed after 20 minutes is regarded as invalid.
 INTERPRETATION OF RESULTSNegative: No apparent band in the test region (T), a purple-colored band appears in the control region(C). This indicates that no TP antibody has been detected.
Positive: In addition to a purple-colored band in the control region (C), a purple-colored band will appear in the test region (T). This indicates that the specimen contains TP antibodies.
Invalid: If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.    


SPECIFICATION
The positive coincidence rate of National reference: 100%.The negative coincidence rate of National reference: 100%.Coefficient of variation: color uniform compared by National CV reference.Specificity: No cross reaction with late pregnant woman serum, rheumatoid arthritis serum, chronic persistent hepatitis serum.
 
LIMITATIONS
The test is to be used for the qualitative detection of antibodies to TP.A negative result does not rule out infection by TP because the antibodies to TP may be absent or may not be present in sufficient quantity to be detected at early stage of infection.