Span Biotech Ltd.

INTENDED USE

One Step Anti-Syphilis Rapid Test is a rapid direct binding test for the visual detection of anti-syphilis antibodies in whole blood, serum or plasma as an aid in the diagnosis of syphilis infection. Test results are read visually without any instrument. It is based on the principle of double antigen sandwich immunoassay for determination of syphilis antibodies in serum. Purified recombinant syphilis antigens are employed to identify anti-Syphilis antibodies specifically. This one step test is very sensitive and only takes about 10 to 20 minutes.

PRINCIPLE 

The One Step Syphilis Test lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant Tp antigens conjugated with colloid gold (Tp conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with non-conjugated recombinant Tp antigens, and the C band is pre-coated with goat anti-rabbit IgG antibody.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. Anti-Tp antibody, if present in the specimen will bind to the Tp conjugates. The immunocomplex is then captured on the membrane by the precoated Tp antigen, forming a burgundy colored T band, indicating a Tp antibody positive test result.

Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless of color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.

REAGENTS AND MATERIALS PROVIDED

1.  One pouched cassette with desiccant.

2.  One piece of operating instruction.

WARNING AND PRECAUTIONS

1.For in vitro diagnostic uses only.

2.All patient samples should be treated as if capable of transmitting diseases.

3.Do not interchange reagents from different lots or use test kit beyond expiration date.

4.Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

STORAGE

Store the test kit at temperature 4-30°C，the sealed pouch for the duration of the shelf life (24 months).

SPECIMEN COLLECTION AND PREPARATION

Plasma

1.Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2.Separate the plasma by centrifugation.

3.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

1.Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

2.Allow the blood to clot.

3.Separate the serum by centrifugation.

4.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.

Blood

Drops of whole blood can be obtained by either finger tip puncture or veinpuncture. Do not use any hemolized blood for testing.

Whole blood specimens should be stored in refrigeration (2°C-8°C) if not tested immediately. The specimens must be tested within 24 hours of collection.

ASSAY PROCEDURE

Add 70-100 ul or 2-3 drops blood or serum or plasma into sample well. Observe the result in 5-30 minutes.

INTERPRETATION OF RESULTS 

1.Negative: No apparent band in the test region(T), a pink-colored band appears in the control region(C). This indicates that no Syphilis antibody has been detected.

2.Positive: In addition to a pink-colored band in the control region(C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains syphilis antibodies.

3.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.

LIMITATION OF THE PROCEDUR

1.The test is to be used for the qualitative detection of antibodies tosyphilis.

2.A negative result does not rule out infection by syphilis because the antibodies to syphilis may be absent or may not be present in sufficient quantity to be detected at early stage of infection.