 Care should be taken to protect the components of the kit from contamination.

on. Do not use if there is TP antibodies in the specimen and should not be used as the sole criteria for the diagnosis of TP
evidence of microbial contamination or precipitation. Biological contamination of dispensing infection.
® Syphilis Rapid Test Device
Fastep D-SYP-42 (Whole Blood /Serum/Plasma)
equipments, containers or reagents can lead to false results.

SPECIMEN COLLECTION AND STORAGE

3. If the test result is negative and clinical symptoms persist, additional testing using other clinical
methods is recommended. A negative result does not at anytime rule out the existence of TP
antibodies in blood, as antibodies may be present below the minimum detection level of the test.
4. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all
 The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is intended for use with human clinical and laboratory findings have been evaluated.
INTENDED USE Whole Blood, serum or plasma specimens only.
 Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma PERFORMANCE CHARACTERISTICS
The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the should be separated as soon as possible to avoid hemolysis.
qualitative, presumptive detection of IgM and IgG antibodies to Treponema Pallidum (TP) in human Whole  Perform testing immediately after specimen collection. Do not leave specimens at room temperature Table: Syphilis Rapid Test vs. TPHA
Blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of syphilis. for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For
long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture Syphilis Rapid Test
INTRODUCTION should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole Relative Sensitivity:
blood specimens. Whole blood collected by fingerstick should be tested immediately. 99.6% (97.8%-99.9%)* + - Total
Treponema Pallidum (TP), a spirochete bacterium with an outer envelope and a cytoplasmic membrane,  Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole Relative Specificity:
is the causative agent of the venereal disease syphilis. Although syphilis rates are declining in the United blood storage. 99.1% (97.5%-99.8%)*
States after an epidemic between 1986 and 1990, the incidence of syphilis in Europe has increased since + 246 1 247
 Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed Overall Agreement: TPHA
1992, especially in the countries of the Russia Federation, where peaks of 263 cases per 100,000 have and mixed well prior to testing. Avoid repeated freezing and thawing of specimens. 99.3% (98.3%-99.8%)*
been reported. In addition, the positive rate of serological test results for syphilis in HIV-infected - 3 343 346
 If specimens are to be shipped, pack them in compliance with all applicable regulations for
individuals has been rising recently. *95% Confidence Interval
transportation of etiological agents. 249 344 593
The serological detection of specific antibodies to TP has been long recognized in the diagnosis of syphilis  Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
since the natural course of the infection is characterized by periods without clinical manifestations. The
antibody response to TP can be detected within 4 to 7 days after the syphilis chancre appears, allowing early PROCEDURE
detection and diagnosis of syphilis infection.
A variety of antigens have been used in syphilis serological tests, such as Rapid Plasma Cardiolipin (RPR) or Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use. LITERATURE REFERENCES
VDRL antigen, TP extracts derived from in vitro culture or inoculated rabbit testes. However, RPR and 1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with
VDRL antigens are not treponemal specific, and whole TP extracts are not reproducible and contain a certain patient or control identification. For best results, the assay should be performed within one hour. 1. Centers for Disease Control (CDC). Chlamydia trachomatis infections. Policy guidelines for
amount of contaminating materials such as flagella, which may lead to a nonspecific reaction in assays of test 2. Using the provided disposable pipette, transfer 3 drops of serum/plasma specimen (approximately prevention and control. MMWR Morb Mortal Wkly Rep. 1985 Aug 23; 34 Suppl 3: 53S-74S.
serum. 75 µL) to the specimen well (S) of the device and start the timer. 2. Tichonova L, Borisenko K, Ward H, Meheus A, Gromyko A, Renton A. Epidemics of syphilis in
OR the Russian Federation: trends, origins, and priorities for control. Lancet. 1997 Jul 19; 350(9072):
PRINCIPLE 210-3.
Transfer 2 drop of whole blood specimen (approximately 50 µL) to the specimen well (S) of the
device with the provided disposable pipette, then add 1 drop of buffer and start the timer. 3. Norgard MV, Chamberlain NR, Swancutt MA, Goldberg MS. Cloning and expression of the major
The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) detects IgM and IgG antibodies to 47-kilodalton surface immunogen of Treponema pallidum in Escherichia coli. Infect Immun. 1986
Treponema Pallidum (TP) through visual interpretation of color development on the internal strip. OR Nov; 54(2): 500-6.
Specific recombinant TP antigens are immobilized on the test region of the membrane. During testing, Allow 2 hanging drops of fingerstick whole blood specimen to fall into the center of the specimen
the specimen reacts with recombinant TP-specific antigen conjugated to colored particles and precoated well (S) on the device, then add 1 drop of buffer and start the timer. GLOSSARY OF SYMBOLS
onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result
interacts with reagents on the membrane. If there are sufficient antibodies to Treponema Pallidum (TP)
in the specimen, a colored band will form at the test region of the membrane. The presence of this
area.  Catalog number 
Temperature limitation
colored band indicates a positive result, while its absence indicates a negative result. The appearance of
As the test begins to work, you will see color move across the membrane.  Consult instructions for use 
Batch code
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the
a colored band at the control region serves as a procedural control, indicating that the proper volume of
result after 20 minutes.  In vitro diagnostic medical device 
Use by
specimen has been added and membrane wicking has occurred.
 Manufacturer 
Do not reuse
MATERIALS INTERPRETATION OF RESULTS Authorized representative in the
 Do not reuse  European Community
Materials Provided
 CE marking according to IVD Medical Devices Directive 98/79/EC
 Individually packed test devices  Package insert C POSITIVE: Two colored bands appear on the membrane. One band appears in
the control region (C) and another band appears in the test region (T).


 Disposable pipettes  T Polymed Therapeutics, Inc

Fastep® 3040 Post Oak Blvd ., Ste 1110

Materials Required but Not provided C NEGATIVE: Only one colored band appears, in the control region (C). No
apparent colored band appears in the test region (T). Houston , TX 77056 , USA
 Specimen collection container  Timer T
 Centrifuge INVALID: Control band fails to appear. Results from any test which has not


C C produced a control band at the specified read time must be discarded. Please review MDSS
PRECAUTIONS the procedure and repeat with a new test. If the problem persists, discontinue using Schiffgraben 41, 30175
T T the kit immediately and contact your local distributor. Hannover, Germany
 For professional in vitro diagnostic use only.
 Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is NOTE:
damaged. Do not reuse tests. 1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present
 This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that
of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
therefore, recommended that these products be treated as potentially infectious, and handled by 2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely
observing usual safety precautions (e.g., do not ingest or inhale). reasons for control band failure.
 Avoid cross-contamination of specimens by using a new specimen collection container for each
specimen obtained. QUALITY CONTROL
 Read the entire procedure carefully prior to testing.
 Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all  Internal procedural controls are included in the test. A colored band appearing in the control region
specimens as if they contain infectious agents. Observe established precautions against (C) is considered an internal positive procedural control, confirming sufficient specimen volume and
microbiological hazards throughout the procedure and follow standard procedures for the proper correct procedural technique.
disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye  External controls are not supplied with this kit. It is recommended that positive and negative
protection when specimens are assayed. controls be tested as a good laboratory practice to confirm the test procedure and to verify proper
 Humidity and temperature can adversely affect results. test performance.
 Used testing materials should be discarded according to local regulations.
LIMITATIONS OF THE TEST
STORAGE AND STABILITY
1. The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is for professional in vitro
 The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch. diagnostic use, and should only be used for the qualitative detection of TP antibodies. No
 The test must remain in the sealed pouch until use. meaning should be inferred from the color intensity or width of any apparent bands.
 Do not freeze. 2. The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) will only indicate the presence of
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