Syphilis Rapid Test Note: All expiration dates are printed in Year-Month-Day format.

n Year-Month-Day format. 2022-06-18 indicates June 18, and another line should be in the test li ne region (T).
2022.
Package Insert *Note: The intensity of the color in the test line region (T) may vary depending on the
SPECIMEN COLLECTION AND HANDLING concentration of TP antibodies present in the specimen. Therefore, any shade of color in the
test line region (T) should be considered positive.
REF VISY-401/VISY-402 English The Syphilis Rapid Test can be performed using whole blood, serum or plasma.
Serum, plasma and whole blood samples must be collected in a clean and dry container. EDTA, Negative：One colored line appears in the control line region (C). No apparent colored line
sodium citrate, heparin can be used as the anticoagulants. Recommend to detect immediately appears in the test line region (T).
INTENDED USE after collecting blood. If blood coagulation occurs, serum sample is suggested to use.
Invalid：Control line fails to appear. Insufficient specimen volume or incorrect procedural
The VivaDiag™ Syphilis Rapid Test is a rapid chromatographic immunoassay for the qualitative Serum/Plasma techniques are the most likely reasons for control line failure. Review the procedure and repeat
detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in human whole blood, • Serum and plasma samples may be stored at 2-8°C for 7 days prior to assay, and at -20°C the test with a new test. If the problem persists, discontinue using the test kit immediately and
serum and plasma samples. It is intended to be used by professionals as a preliminary test for a long time. contact your local distributor.
result to aid in diagnosis of infection with Syphilis. For in vitro diagnostic use only. • Frozen and refrigerated samples should be equilibrated to room temperature before
detection and thoroughly mixed. QUALITY CONTROL
SUMMARY
• Avoid repeated freeze-thaw, Samples that exhibiting visible precipitates, stink or muddy • A procedural control is included in the test. A colored line appearing in the control line
Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a should not be used. region (C) is considered an internal procedural control. It confirms sufficient specimen
spirochete bacterium with an outer envelope and a cytoplasmic membrane. Relatively little is volume, adequate membrane wicking and correct procedural technique.
Whole Blood
known about the organism in comparison with other bacterial pathogens. According to the • Control standards are not supplied with this kit; however, it is recommended that positive
Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly • Whole blood samples with anticoagulants may be stored at 2-8°C for 24 hours, and should
and negative controls be tested as a good laboratory practice to confirm the test procedure
increased since 1985. Some key factors that have contributed to this rise include the crack be used immediately without anticoagulants. DO NOT FREEZE. Mix the sample well by
and to verify proper test performance.
cocaine epidemic and the high incidence of prostitution among drug users. One study reported gentle inversion of the tube immediately before testing.
a substantial epidemiological correlation between the acquisition and transmission of the HIV LIMITATIONS
virus and Syphilis.
TEST PROCEDURE
Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Please read the instructions carefully before testing. Allow equipment, buffers, and samples to • The Syphilis Rapid Test is for in vitro diagnostic use only. The test should be used for the
Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The equilibrate to room temperature (15°C to 30°C) prior to testing. detection of TP antibodies in whole blood, serum or plasma specimens only. Neither the
antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre quantitative value nor the rate of increase in TP antibodies can be determined by this
appears. The infection remains detectable until the patient receives adequate treatment. [For Strip] qualitative test.
The Syphilis Rapid Test utilizes a double antigen combination of a Syphilis antigen coated 1. Take out a test strip from sealed foil pouch and put it on a clean and level surface. • The Syphilis Rapid Test will only indicate the presence of TP antibodies in the specimen
particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) 2. Hold the dropper vertically and transfer 2 drops of sample (approx. 40-60 µL) into the and should not be used as the sole criteria for the diagnosis of TP infection.
qualitatively and selectively in whole blood, serum or plasma. specimen pad of the test strip, then add 1 drop of buffer (approx. 40 µL) and start the timer. • As with all diagnostic tests, all results must be interpreted together with other clinical
3. Wait for the red line(s) to appear. Read the test result at 10 minutes. Don't read the result information available to the physician.
PRINCIPLE after 20 minutes. • If the test result is negative and clinical symptoms persist, additional testing using other
The VivaDiag™ Syphilis Rapid Test is a lateral flow chromatographic immunoassay. The test clinical methods is recommended. A negative result does not at any time preclude the
device/strip consists of: 1) a burgundy colored conjugate pad containing recombinant Syphilis possibility of TP infection.
antigen conjugated with colloidal gold (antibody conjugates), 2) a nitrocellulose membrane strip
containing a test line (T line) and a control line (C line). The T line is pre-coated with
PERFORMANCE
recombinant Syphilis antigen, and the C line is pre-coated with mouse anti-TP antibody. 1. Accuracy
2 drops 1 drop
After a specimen is added to the specimen pad it reacts with Syphilis antigen coated particles The Syphilis Rapid Test has been compared to a leading commercial TPHA Syphilis test using
that have been applied to the specimen pad. This mixture migrates chromatographically along clinical specimens. The results show that the relative sensitivity of the Syphilis Rapid Test.
the length of the test and interacts with the immobilized Syphilis antigen. The double antigen
test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies,
a colored line will appear in the test line region, indicating a positive result. If the specimen does VivaDiag™ Syphilis TPHA
not contain TP antibodies, a colored line will not appear in this region, indicating a negative
Rapid Test Strip Positive Negative Total
result. To serve as a procedural control, a colored line will always appear in the control line
region, indicating that proper volume of specimen has been added and membrane wicking has [For Device]
Positive 411 8 419
occurred. 1. Take out a test device from sealed foil pouch and put it on a clean and level surface.
2. Using the dropper, vertically transfer 2 drops (approx. 40-60 µL) of sample into the Negative 6 529 535
WARNINGS AND PRECAUTIONS specimen well (S) of the test, then add 1 drop of buffer (approx. 40 µL) and start the timer.
avoiding the formation of bubbles. Total 417 537 954
• For in vitro diagnostic use only.
3. Wait for the red line(s) to appear. Read the test result at 10 minutes. Don't read the result
• Do not use after expiration date. Sensitivity 98.6% (411/417, 95%CI, 96.9%-99.5%) *
after 20 minutes.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not use the test if pouch is damaged. Specificity 98.5% (529/537, 95%CI, 97.1%-99.4%) *
• Handle all specimens as if they contain infectious agents. Observe established precautions Accuracy 98.5% (940/ 954,95%CI, 97.6%-99.2 %) *
against microbiological hazards throughout all procedures and follow the standard
procedures for proper disposal of specimens. 2. Cross-Reactivity
2 drops 1 drop
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection The addition of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, toxoplasma
when specimens are assayed. gondii, rubella virus, cytomegalovirus, herpes simplex virus type I, herpes simplex virus type II,
• The used test should be discarded according to local regulations. samples showed no cross-reactivity.
• Humidity and temperature can adversely affect results.
3. Interfering Substances
COMPOSITION 1000 mol/L bilirubin, 5.65 mmol/L triglyceride, 6.5 g/L hemoglobin has no effect on the detection
Materials provided and available for purchase result. The reagent is not affected by the rheumatoid factor, Antinuclear antibodies.
1. Test strip/device (dropper) in foil pouch REFERENCES
2. Buffer
3. Package insert 1. Claire M. Fraser. Complete genome sequence of Treponema Pallidum, the Syphilis
Materials required but not provided: INTERPRETATION OF TEST RESULTS spirochete, Science 1998; 281 July: 375-381
1. Specimen collection container 2. Center for Disease Control. Recommendations for diagnosing and treating Syphilis in
2. Centrifuge (for serum/plasma samples) HIV-infected patients, MMWR Morb. Mortal Wkly Rep. 1988; 37: 601
3. Timer 3. Aral R. Marx. Crack, sex and STD, Sexually Transmitted Diseases, 1991; 18:92-101
4. Personal protective equipment, such as protective gloves, medical masks, lab coats, etc. 4. J.N. Wasserheit. Epidemiological Synergy: Interrelationships between human
5. Appropriate biohazardous waste containers and disinfectants. immunodeficiency virus infection and other sexually transmitted diseases, Sexually
Transmitted Diseases 1992; 19:61-77
STORAGE AND HANDLING 5. Johnson Phillip C.Testing for Syphilis, Dermatologic Clinic 1994; 12 Jan: 9-17

• Store the test kit in a cool, dry place between 36-86°F (2-30°C). Keep away from light.
Exposure to temperature and/or humidity outside the specified conditions may cause
inaccurate results.
• Do not freeze. Use the test kit at temperatures between 59-86°F (15-30°C). Positive Negative Invalid
• Use the test kit between 10-90% humidity. Positive*：Two distinct colored lines appear. One line should be in the control line region (C)
• Do not use the test kit beyond the expiration date (printed on the foil pouch and box).
 INDEX OF SYMBOLS

Consult instructions for Contains sufficient

Authorized Representative

Number: 1624015603
Effective date:2024-01-18