Syphilis Rapid Test Kit (Lateral Chromatography)

Product Details:

Intended Use:

Syphilis Rapid Test Kit (Lateral Chromatography) is a rapid chromatographic immunoassay for the qualitative detection of TP antibodies in whole blood, serum or plasma to aid in the diagnosis of syphilis.

Test Principles:

The Syphilis Rapid Test Kit is based on immunochromatographic assay to detect TP antibodies in whole blood, serum or plasma. During the test, TP antibodies conjugate with TP antigens labeled on colored spherical particles to form immune complex. Owing to capillary action, immune complex flow across the membrane. If the sample contains TP antibodies, it will be captured by the pre-coated test area and form a visible test line. To serve as a procedure control, a colored control line will appear if the test has been performed properly

Main Contents:

For Stripe:

For Cassette:

Operation Flow

• Step 1: Sample Preparation

Syphilis Rapid Test Kit (Lateral Chromatography) can be performed using whole blood, serum or plasma.

1. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.

2. Testing should be performed immediately after the specimens have been collected. If testing can not be completed immediately, the serum and plasma sample should be stored at 2-8°C for up to 3 days, for long term storage, specimens should be stored at -20℃. Whole blood collected by venipuncture should be stored at 2- 8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

3. Samples must be recovered to room temperature before testing. Frozen samples are required to be completely thawed and mixed thoroughly prior to testing, avoiding repeatedly freezing and thawing.

4. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

• Step 2: Testing

Allow the test strip/cassette, specimen, sample diluent to reach room

temperature (15-30°C) prior to testing.

1. Remove the test strip/cassette from the sealed pouch and use it within 30 minutes.

2. Place the test strip/cassette on a clean and level surface.

2.1 For Serum or Plasma Specimens:

Hold the dropper vertically, draw the specimen up to the lower Fill Line (approximately 40uL), and transfer the specimen to the specimen well (S) of the test strip/cassette, then add 1 drop of sample diluent (approximately 40uL) and start the timer. Avoid trapping air bubbles in the specimen well(S). See illustration below.

2.2 For Whole Blood (Venipuncture/ Fingerstick) Specimens:

Hold the dropper vertically, draw the specimen to the upper Fill Line (approximately 80uL), and transfer whole blood to the specimen well (S) of the test strip/cassette, then add 1 drop of sample diluent (approximately 40uL) and start the timer. Avoid trapping air bubbles in the specimen well(S). See illustration below.

• Step 3: Reading

3. Visually read the result after 10-20 minutes. The result is invalid after 20 minutes.

Interpreting the results

1. Positive Result

If both the quality control C line and the detection T line appear, it indicates that the specimen contains detectable amount of TP antibodies, and the result is positive for syphilis.

2. Negative Result

If only the quality control C line appears and the detection T line does not show color, it indicates that TP antibodies is not detectable in the specimen. and the result is negative for syphilis.

3. Invalid Result

No visible colored band appears at control line after performing the test, the test result is invalid. Retest the sample.

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