Syphilis Rapid Test Dipstick clear non-hemolyzed specimens. the diagnosis of TP infection.

 Testing should be performed immediately after the specimens have been collected. Do 3. As with all diagnostic tests, all results must be interpreted together with other clinical
(Whole Blood /Serum/Plasma) not leave the specimens at room temperature for prolonged periods. Serum and plasma information available to the physician.
specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens 4. If the test result is negative and clinical symptoms persist, additional testing using other
Package Insert should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2- clinical methods is recommended. A negative result does not at any time preclude the
A rapid test for the diagnosis of Syphilis to detect antibodies (IgG and IgM) to Treponema 8°C if the test is to be run within 2 days of collection. Do not freeze whole blood possibility of TP infection.
Pallidum (TP) qualitatively in whole blood, serum or plasma. specimens. Whole blood collected by fingerstick should be tested immediately. 【PERFORMANCE CHARACTERISTICS】
For professional in vitro diagnostic use only.  Bring specimens to room temperature prior to testing. Frozen specimens must be Sensitivity and Specificity
【INTENDED USE】 completely thawed and mixed well prior to testing. Specimens should not be frozen and The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) has correctly identified
The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) is a rapid chromatographic thawed repeatedly. specimens of a performance panel and has been compared to a leading commercial TPPA
immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema  If specimens are to be shipped, they should be packed in compliance with local Syphilis test using clinical specimens. The results show that the relative sensitivity of the
Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis. regulations covering the transportation of etiologic agents. Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) is >99.9% and the relative
【SUMMARY】 【MATERIALS】 specificity is 99.7%.
Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a Materials provided Method TPPA
spirochete bacterium with an outer envelope and a cytoplasmic membrane. 1 Relatively little Total Result
Syphilis Rapid Test Dipstick Results Positive Negative
is known about the organism in comparison with other bacterial pathogens. According to the  Test dipsticks  Droppers  Buffer  Package insert
Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly (Whole Positive 200 1 201
Materials required but not provided Blood/Serum/Plasma) Negative 0 319 319
increased since 1985.2 Some key factors that have contributed to this rise include the crack  Specimen collection Containers  Centrifuge  Timer
cocaine epidemic and the high incidence of prostitution among drug users.3 One study For fingerstick whole blood
Total Result 200 320 520
reported a substantial epidemiological correlation between the acquisition and transmission Relative Sensitivity: ＞99.9% (95%CI*: 99.4%-100%)
 Lancets  Heparinized capillary tubes and dispensing bulb
of the HIV virus and Syphilis.4 【DIRECTIONS FOR USE】
Relative Specificity: 99.7% (95%CI*: 98.3%-100%)
Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic Accuracy: 99.8% (95%CI*: 98.9%-100%) *Confidence Interval
Allow the test, specimen, buffer and/or controls to reach room temperature (15-
of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. Precision
30°C) prior to testing.
The antibodies response to the TP bacterium can be detected within 4 to 7 days after the Intra-Assay
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the
chancre appears. The infection remains detectable until the patient receives adequate Within-run precision has been determined by using 10 replicates of four specimens: a
sealed pouch and use it as soon as possible.
treatment.5 2. For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of
negative, a low positive, a medium positive and a high positive. The negative, low positive,
The Syphilis Rapid Test Dipstick(Whole Blood/Serum/Plasma) utilizes a double antigen medium positive and high positive values were correctly identified >99% of the time.
serum or plasma (approximately 40 L) to the specimen area, then add 1 drop of buffer
combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on Inter-Assay
(approximately 40 L),and start the timer, see illustration below.
membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in whole blood, Between-run precision has been determined by 10 independent assays on the same four
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2
serum or plasma. specimens: a negative, a low positive, a medium positive and a high positive. Three different
drops of whole blood (approximately 80 L) to the specimen area, then add 1 drop of
【PRINCIPLE】 lots of the Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) have been tested over
buffer (approximately 40 L), and start the timer. See illustration below.
The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) is a qualitative membrane a 3-day period using negative, low positive, medium positive and high positive specimens.
For Fingerstick Whole Blood specimen:
based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum The specimens were correctly identified >99% of the time.
 To use a capillary tube: Fill the capillary tube and transfer approximately 80 L of
or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line Cross-reactivity
fingerstick whole blood specimen to the specimen area of test dipstick, then add 1
region of the test. After specimen is added to the specimen area of the dipstick, it reacts with The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) has been tested by HAMA,
drop of buffer (approximately 40 L) and start the timer. See illustration below.
Syphilis antigen coated particles in the test. This mixture migrates chromatographically along RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, HIV, H. Pylori, MONO, CMV, Rubella
 To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen
the length of the test and interacts with the immobilized Syphilis antigen. The double antigen and TOXO positive specimens. The results showed no cross-reactivity.
(approximately 80 L) to fall into the specimen area of test dipstick, then add 1 drop of
test format can detect both IgG and IgM in specimens. If the specimen contains TP Interfering Substances
buffer (approximately 40 L) and start the timer. See illustration below.
antibodies, a colored line will appear in the test line region, indicating a positive result. If the The following potentially interfering substances were added to Syphilis negative and positive
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the
specimen does not contain TP antibodies, a colored line will not appear in this region, specimens.
result after 20 minutes.
indicating a negative result. To serve as a procedural control, a colored line will always Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
appear in the control line region, indicating that proper volume of specimen has been added Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
and membrane wicking has occurred. Ascorbic Acid: 2g/dL Albumin: 2 g/dL
【REAGENTS】 Creatin: 200 mg/dL Hemoglobin 1.1 mg/dL
The test contains Syphilis antigen coated particles and Syphilis antigen coated on the Bilirubin: 1g/dL Oxalic Acid: 600mg/dL
membrane. None of the substances at the concentration tested interfered in the assay.
【PRECAUTIONS】 【BIBLIOGRAPHY】
 For professional in vitro diagnostic use only. Do not use after expiration date. 1. Claire M. Fraser. Complete genome sequence of Treponema Pallidum, the Syphilis
 Do not eat, drink or smoke in the area where the specimens or kits are handled. spirochete, Science 1998; 281 July: 375-381
 Do not use test if pouch is damaged. 2. Center for Disease Control. Recommendations for diagnosing and treating Syphilis in HIV-
 Handle all specimens as if they contain infectious agents. Observe established infected patients, MMWR Morb. Mortal Wkly Rep. 1988; 37: 601
precautions against microbiological hazards throughout all procedures and follow the 3. Aral R. Marx. Crack, sex and STD, Sexually Transmitted Diseases, 1991; 18:92-101
standard procedures for proper disposal of specimens. 4. J.N. Wasserheit. Epidemiological Synergy: Interrelationships between human
 Wear protective clothing such as laboratory coats, disposable gloves and eye protection immunodeficiency virus infection and other sexually transmitted diseases, Sexually
when specimens are assayed. Transmitted Diseases 1992; 19:61-77
 The used test should be discarded according to local regulations. 5. Johnson Phillip C.Testing for Syphilis, Dermatologic Clinic 1994; 12 Jan: 9-17
 Humidity and temperature can adversely affect results.
【STORAGE AND STABILITY】
Store as packaged in the sealed pouch either at room temperature or refrigerated (2 -
30°C). The test is stable through the expiration date printed on the sealed pouch. The
test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the 【INTERPRETATION OF RESULTS】
expiration date. (Please refer to the illustration above)
【SPECIMEN COLLECTION AND PREPARATION】 POSITIVE:* Two colored lines appear. One colored line should be in the control line region Number: 14601112800
 The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) can be performed using (C) and another colored line should be in the test line region (T). Revision Date: 2022-09-27
whole blood (from venipuncture or fingerstick), serum or plasma. *NOTE: The intensity of the color in the test line region (T) will vary depending on the
 To collect Fingerstick Whole Blood specimens: concentration of TP antibodies present in the specimen. Therefore, any shade of color in the
 Wash the patient’s hand with soap and warm water or clean with an alcohol swab. test line region (T) should be considered positive.
Allow to dry. NEGATIVE: One colored line appears in the control line region (C). No line appears in
 Massage the hand without touching the puncture site by rubbing down the hand the test line region (T).
towards the fingertip of the middle or ring finger. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
 Puncture the skin with a sterile lancet. Wipe away the first sign of blood. techniques are the most likely reasons for control line failure. Review the procedure and
 Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over repeat the test with a new test. If the problem persists, discontinue using the test kit
the puncture site. immediately and contact your local distributor.
 Add the Fingerstick Whole Blood specimen to the test by using a capillary tube: 【QUALITY CONTROL】
 Touch the end of the capillary tube to the blood until filled to approximately 80 L. A procedural control is included in the test. A colored line appearing in the control line
Avoid air bubbles. region (C) is considered an internal procedural control. It confirms sufficient specimen
 Place the bulb onto the top end of the capillary tube, then squeeze the bulb to volume, adequate membrane wicking and correct procedural technique.
dispense the whole blood to the specimen area of the test dipstick. Control standards are not supplied with this kit; however, it is recommended that positive and
 Add the Fingerstick Whole Blood specimen to the test by using hanging drops: negative controls be tested as a good laboratory practice to confirm the test procedure and
 Position the patient’s finger so that the drop of blood is just above the specimen area to verify proper test performance.
of the test dipstick. 【LIMITATIONS】
 Allow 2 hanging drops of fingerstick whole blood to fall into the center of the 1. The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) is for in vitro diagnostic
specimen area on the test dipstick, or move the patient’s finger so that the hanging use only. The test should be used for the detection of TP antibodies in whole blood, serum
drop touches the center of the specimen area. Avoid touching the finger directly to or plasma specimens only. Neither the quantitative value nor the rate of increase in TP
the specimen area. antibodies can be determined by this qualitative test.
2. The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) will only indicate the
 Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only presence of TP antibodies in the specimen and should not be used as the sole criteria for