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1. Purpose
SD Bioline syphilis test device is a rapid chromatographic immunoassay for the qualitative
detection of antibodies of all isotypes ( IgG,IgM,IgA) against Treponema pallidum (TP)in
serum or plasma
2. Scope:
This procedure applies to All staff working in serology section
3. Responsibility:
The head of Serology section is responsible for ensuring the effective implementation and
competency assessment of this procedure

4. Principle
SD Bioline syphilis contains a membrane strip which pre-coated with recombinant
Treponema Pallidum antigens (17,15KDa) on a test band region. The recombinant
Treponema pallidum antigens colloid gold conjugate (17,15KDa), patient sample and sample
diluent moves along the membrane chromatographically to the test region (T) and forms a
visible line as the antigen-antibody-antigen-gold complex forms. Therefore, a formation of a
visible line in the test (T) region indicates a positive result for the detection of Treponema
Pallidum specific antibodies (IgG, IgM, IgA). When the Treponema Pallidum specific
antibodies ((IgG, IgM, IgA) are absent in the sample, no visible colour band in the test
region.
5. Materials:
Reagent Supplies Equipment
 Test device  Capillary pipette  Timer

 Assay diluent  Blood lancets  Refrigerator for

 Micropipettes storage of samples
 Micro-tips( 20 -50µl)
 Gloves
 Permanent marker pen

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6. Sample and container type
 Whole blood collected in heparin or EDTA or sodium citrate anticoagulant can be used.
If not tested immediately, should be stored at 2-8°C and blood should be tested within
three (3) days after collection.
 Plasma or serum can also be used. If not tested immediately, should be stored at 2-8 0C.
For storage period longer than 2 weeks, freezing is recommended.
7. Environmental and safety controls
 All blood samples and reagents must be considered as potentially infectious. Their
handling need the use of appropriate personal protective equipment (e.g. gloves, lab
coat, etc.).
 Room and refrigerator temperatures are monitored twice daily
 Clean working bench before and after work with 0.5% Sodium Hypochlorite

8. Calibration: N/A
9. Quality control
 Quality control materials are sourced from Northern Zonal Blood Transfusion (NZBTS)
and selected referral laboratory.
 The test strip contains a built in control line
 Run known positive and negative in house controls weekly and on each new batch of test
device to validate manufacturer built-in controls.
10. Procedure
 Remove the test device from foil pouch place it on the flat dry surface
 Label the device with sample identification number
For serum or plasma samples:
 Using micropipette add 10µl of serum or plasma into the sample well(S).
 Add 4 drops (about 120µl) of assay diluents Wait for a minimum of 5 – 20 minutes
and read results
For whole blood (venepuncture) samples:
 Using micropipette add 20µl of whole blood into the sample well (S).
 Add 4 drops (about 120µl) of assay diluents
 Wait for a minimum of 5 – 20 minutes and read results

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11. Calculations: N/A
12. Interferences/Limitations
 The SD Bioline (Syphilis) 3.0 test will only indicate the presence of TP antibodies in the
specimen and should not be used as the sole criteria for the diagnosis of TP infection.
 As with all diagnostic tests, all results must be interpreted together with clinical
information available to physician.
 If the test result is negative and clinical symptom is persist, additional testing using other
clinical methods is recommended. A negative result does not any time preclude the
possibility of TP infection.
13. Panic/Critical values Results reporting: N/A
14. Interpretation of the results
 Negative:
 Only one purple colour band appears within the result window
 Positive:
 Two colour bands (“T” and “C” bands) within the result window no matter which
band appears first
 Invalid:
 Purple colour band is not visible within the test result window
15. Reporting results:
 Positive test results: Report as Reactive
 Negative test results: Report as Non-reactive
16. Biological Reference interval: N/A
17. Performance characteristics
 Refer to data on verification of this method

18. Supportive Document:

 Qualitative Quality control log
19. References:
 SD bioline Package Insert SD Standard Diagnostics, INC, Korea.

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AMENDMENT SHEET
Amendment Version Reviewed by Next review date

Revision date

Staff acknowledgement documentation log

I do hereby acknowledge that I have read and understood the content of this document.
N° Staff Name Staff signature Date

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