FAMKA 30229 Syphilis Ab Test Card Instruction Manual

: June 5, 2024
: FAMKA

Table of Contents

FAMKA 30229 Syphilis Ab Test Card
Introduction
Materials Required But Not Provided
Storage And Stability
Specimen Collection
Test Procedure
Interpretation Of Results
Precaution
Limitation
References
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FAMKA 30229 Syphilis Ab Test Card

Introduction

ANTI-TP Rapid Screen Test is a chromatographic immunoassay for the qualitative detection of antibodies to TP in human serum. Two Purified recombinant antigens of TP are used in the test band as capture materials and gold conjugates. If the antibody of Anti-TP is present in the sample in a concentration above the labeled, a complex will be formed. This complex is then captured by antigens immobilized in the Test Zone of the membrane, producing a visible pink-rose color band on the membrane. The color intensity will depend on the concentration of the anti-TP present in the sample. This one-step test is very sensitive and only takes about 15 minutes. Test results are read visually without any instrument.
Materials And Components Materials ProvidedIndividually sealed foil pouches containing:

One cassette test device.
One buffer
One plastic dropper
Lancet
Alcohol Wipe
One package insert (instruction for use)

Materials Required But Not Provided

sample collection containers
timer or clock

Storage And Stability

The test kit can be stored at room temperature (2 to 30°C) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture, and heat.

Specimen Collection

For serum, collect blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot. For plasma, collect whole blood into a purple, blue, or green top collection tube (containing EDTA, citrate, or heparin, respectively) by vein puncture, separating plasma from whole blood. Use the specimen inside an hour. If the specimen can not be tested within an hour, store the specimen in 4 t cold closet or refrigerator but don’t freeze. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

Test Procedure

Open a pouch containing a cassette and lay the cassette.
Using the plastic dropper provided, draw two or three drops of sample into the sample well of the cassette.
Read results within 15 minutes. Do not read results after 20 minutes.

Interpretation Of Results

Negative: Only one pink band appears on the test region of the Cassette. This indicates that there is no detectable anti-TP in the serum.
Positive: Two pink bands appear on the test region of the Cassette. This indicates that the specimen contains a detectable amount of anti-TP.
Invalid: If without colored band appears on the test region of the Cassette, this is an indication of a possible error in performing the test. The test should be repeated using a new device.

Precaution

Must use fresh specimen and avoid repetitive freezing, the result will be invalid
Use it before the expiry date.
The package kit should not be opened until it reaches room temperature if it was taken out from the refrigerator.
Old Serum can not be used. If the serum is thick, it can be used only after being separated.