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Standard Operating Procedure For Syphilis Rapid Test Using Bioline Syphilis 3

The document outlines the Standard Operating Procedure for the Bioline Syphilis 3.0 Rapid Test, which qualitatively detects antibodies against Treponema pallidum in human serum, plasma, or whole blood. It details the testing principle, specimen requirements, materials needed, and step-by-step procedure for conducting the test, as well as how to interpret results and necessary precautions. Quality control measures and documentation requirements are also specified to ensure accurate and safe testing.

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Ryan Christian Lupos
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65 views2 pages

Standard Operating Procedure For Syphilis Rapid Test Using Bioline Syphilis 3

The document outlines the Standard Operating Procedure for the Bioline Syphilis 3.0 Rapid Test, which qualitatively detects antibodies against Treponema pallidum in human serum, plasma, or whole blood. It details the testing principle, specimen requirements, materials needed, and step-by-step procedure for conducting the test, as well as how to interpret results and necessary precautions. Quality control measures and documentation requirements are also specified to ensure accurate and safe testing.

Uploaded by

Ryan Christian Lupos
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Standard Operating Procedure for Syphilis Rapid Test Using Bioline Syphilis 3.

Purpose:

To qualitatively detect antibodies against Treponema pallidum (causative agent of syphilis) in human
serum, plasma, or whole blood using Bioline Syphilis 3.0 Rapid Test.

Principle:

The Bioline Syphilis 3.0 test is an immunochromatographic assay. If anti-T. pallidum antibodies are
present, they bind to recombinant T. pallidum antigen-conjugated particles and are captured by
immobilized antigen on the test strip, producing a visible line.

Specimen:

 Serum, plasma, or whole blood

 Capillary (fingerstick) or venous sample

Materials and Reagents:

 Bioline Syphilis 3.0 test device

 Sample dropper

 Assay buffer

 Lancet (for fingerstick)

 Alcohol swab

 Timer

 Disposable gloves

 Biohazard waste container

Procedure:

1. Preparation:
a. Allow test device and sample to reach room temperature (15–30°C).
b. Confirm the expiration date on the test kit.
c. Wear gloves and observe biosafety precautions.

2. Sample Collection:

o For whole blood: use fingerstick or venous blood in EDTA/heparin.

o For serum/plasma: collect blood and separate by centrifugation.

3. Testing Procedure:
a. Remove the test device from the pouch and place it on a flat surface.
b. Using the provided dropper:

o Add 1 drop (approx. 10 µL) of whole blood, serum, or plasma to the sample well.
c. Add 1 drop (approx. 60–80 µL) of assay buffer to the buffer well.
d. Start the timer.
e. Read results at 15–20 minutes. Do not read after 30 minutes.

Interpretation of Results:

 Positive: Two red lines (test and control) appear, even if the test line is faint.

 Negative: Only one red line (control line) appears.

 Invalid: No control line appears, regardless of the test line. Repeat with a new test device.
Quality Control:

 Run positive and negative controls (if available) with each new lot or shipment.

 Always check the control line to validate each test.

Storage:

 Store the kit at 1–30°C.

 Do not freeze.

 Use within expiration date.

Precautions:

 For in vitro diagnostic use only.

 Do not reuse test devices.

 Dispose of all materials as biohazard waste.

 Do not use if the pouch is damaged.

Documentation:

Record patient name/ID, test result, date, time, and technician initials in the laboratory logbook or
LIS.

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