Syphilis Rapid Test Dipstick

(Whole Blood /Serum/Plasma)

Package Insert
A rapid test for the diagnosis of Syphilis to detect antibodies (IgG and IgM) to Treponema Pallidum

TestCard

TestCard
(TP) qualitatively in whole blood. serum or plasma.
For professional in vitro diagnostic use only.
INTENDED USE
The Syphilis Rapid Test Dipstick(Whole Blood/Serum/Plasma) is a rapid chromatographic
immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in
whole blood, serum or plasma to aid in the diagnosis of Syphilis.
SUMMARY
Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete
bacterium with an outer envelope and a cytoplasmic membrane. 1 Relatively little is known about the

TestCard

TestCard
organism in comparison with other bacterial pathogens. According to the Center for Disease Control
(CDC), the number of cases of Syphilis infection has markedly increased since 1985. 2 Some key
factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of INTERPRETATION OF RESULTS
prostitution among drug users.3 One study reported a substantial epidemiological correlation between (Please refer to the illustration above)
the acquisition and transmission of the HIV virus and Syphilis. 4 POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another
Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. apparent colored line should be in the test line region (T).
Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies *NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of
response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should
infection remains detectable until the patient receives adequate treatment. 5 be considered positive.
The Syphilis Rapid Test Dipstick(Whole Blood/Serum/Plasma) utilizes a double antigen combination NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line
of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP region (T).
antibodies (IgG and IgM) qualitatively and selectively in whole blood, serum or plasma. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
PRINCIPLE techniques are the most likely reasons for control line failure. Review the procedure and repeat the
The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) is a qualitative membrane based test with a new test. If the problem persists, discontinue using the test kit immediately and contact
immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In your local distributor.
this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the test. After QUALITY CONTROL
specimen is added to the specimen well of the dipstick, it reacts with Syphilis antigen coated particles A procedural control is included in the test. A colored line appearing in the control line region (C) is
in the test. This mixture migrates chromatographically along the length of the test and interacts with considered an internal procedural control. It confirms sufficient specimen volume, adequate
the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in membrane wicking and correct procedural technique.
specimens. If the specimen contains TP antibodies, a colored line will appear in the test line region, Control standards are not supplied with this kit; however, it is recommended that positive and
negative controls be tested as a good laboratory practice to confirm the test procedure and to verify
indicating a positive result. If the specimen does not contain TP antibodies, a colored line will not
proper test performance.
appear in this region, indicating a negative result. To serve as a procedural control, a colored line will LIMITATIONS
always appear in the control line region, indicating that proper volume of specimen has been added 1. The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) is for in vitro diagnostic use
and membrane wicking has occurred. only. The test should be used for the detection of TP antibodies in whole blood, serum or plasma
REAGENTS specimens only. Neither the quantitative value nor the rate of increase in TP antibodies can be
The test contains Syphilis antigen coated particles and Syphilis antigen coated on the membrane. determined by this qualitative test.
PRECAUTIONS 2. The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) will only indicate the presence
 For professional in vitro diagnostic use only. Do not use after expiration date. of TP antibodies in the specimen and should not be used as the sole criteria for the diagnosis of TP
 Do not eat, drink or smoke in the area where the specimens or kits are handled. infection.
 Do not use test if pouch is damaged. 3. As with all diagnostic tests, all results must be interpreted together with other clinical
 Handle all specimens as if they contain infectious agents. Observe established precautions against information available to the physician.
microbiological hazards throughout all procedures and follow the standard procedures for proper 4. If the test result is negative and clinical symptoms persist, additional testing using other
disposal of specimens. clinical methods is recommended. A negative result does not at any time preclude the possibility of
 Wear protective clothing such as laboratory coats, disposable gloves and eye protection when TP infection.
EXPECTED VALUES
specimens are assayed.
The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) has been compared with a leading
 The used test should be discarded according to local regulations.
commercial TPPA Syphilis test, demonstrating an overall accuracy greater than or equal to 99.8%.
 Humidity and temperature can adversely affect results. PERFORMANCE CHARACTERISTICS
STORAGE AND STABILITY Sensitivity and Specificity
Store as packaged in the sealed pouch either at room temperature or refrigerated (2 -30°C). The The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) has correctly identified specimens of a
test is stable through the expiration date printed on the sealed pouch. The test must remain in the performance panel and has been compared to a leading commercial TPPA Syphilis test using clinical
sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date. specimens. The results show that the relative sensitivity of the Syphilis Rapid Test Dipstick (Whole
SPECIMEN COLLECTION AND PREPARATION Blood/Serum/Plasma) is >99.9% and the relative specificity is 99.7%.
 The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) can be performed using whole Method TPPA
Total Result
blood (from venipuncture or fingerstick), serum or plasma. Results Positive Negative
Syphilis Rapid Test Dipstick
 To collect Fingerstick Whole Blood specimens: (Whole Blood/Serum/Plasma) Positive 200 1 201
 Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry. Negative 0 319 319
 Massage the hand without touching the puncture site by rubbing down the hand towards the Total Result 200 320 520
fingertip of the middle or ring finger. Relative Sensitivity: ＞99.9% (95%CI*: 99.4%-100%)
Relative Specificity: 99.7% (95%CI*: 98.3%-100%)
 Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Accuracy: 99.8% (95%CI*: 98.9%-100%) *Confidence Interval
 Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the Precision
puncture site. Intra-Assay
 Add the Fingerstick Whole Blood specimen to the test by using a capillary tube: Within-run precision has been determined by using 10 replicates of four specimens: a negative, a low
 Touch the end of the capillary tube to the blood until filled to approximately80 L. Avoid air positive, a medium positive and a high positive. The negative, low positive, medium positive and high
bubbles. positive values were correctly identified >99% of the time.
 Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the Inter-Assay
whole blood to the specimen area of the test dipstick. Between-run precision has been determined by 10 independent assays on the same four specimens:
 Add the Fingerstick Whole Blood specimen to the test by using hanging drops: a negative, a low positive, a medium positive and a high positive. Three different lots of the Syphilis
 Position the patient’s finger so that the drop of blood is just above the specimen area of the Rapid Test Dipstick (Whole Blood/Serum/Plasma) have been tested over a 3-day period using
test dipstick. negative, low positive, medium positive and high positive specimens. The specimens were correctly
 Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen area identified >99% of the time.
Cross-reactivity
on the test dipstick, or move the patient’s finger so that the hanging drop touches the center
The Syphilis Rapid Test Dipstick (Whole Blood/Serum/Plasma) has been tested by HAMA, RF,
of the specimen area. Avoid touching the finger directly to the specimen area. HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, HIV, H. Pylori, MONO, CMV, Rubella and TOXO
 Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non- positive specimens. The results showed no cross-reactivity.
hemolyzed specimens. Interfering Substances
 Testing should be performed immediately after the specimens have been collected. Do not leave The following potentially interfering substances were added to Syphilis negative and positive
the specimens at room temperature for prolonged periods. Serum and plasma specimens may be specimens.
stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick Ascorbic Acid: 2g/dL Albumin: 2 g/dL
should be tested immediately. Creatin: 200 mg/dL Hemoglobin 1.1 mg/dL
 Bring specimens to room temperature prior to testing. Frozen specimens must be completely Bilirubin: 1g/dL Oxalic Acid: 600mg/dL
thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. None of the substances at the concentration tested interfered in the assay.
 If specimens are to be shipped, they should be packed in compliance with local regulations BIBLIOGRAPHY
covering the transportation of etiologic agents. 1. Claire M. Fraser. Complete genome sequence of Treponema Pallidum, the Syphilis spirochete,
MATERIALS Science 1998; 281 July: 375-381
Materials provided 2. Center for Disease Control. Recommendations for diagnosing and treating Syphilis in HIV-infected
 Test dipsticks  Droppers  Buffer  Test cards  Package insert patients, MMWR Morb. Mortal Wkly Rep. 1988; 37: 601
Materials required but not provided 3. Aral R. Marx. Crack, sex and STD, Sexually Transmitted Diseases, 1991; 18:92-101
 Specimen collection Containers  Centrifuge  Timer 4. J.N. Wasserheit. Epidemiological Synergy: Interrelationships between human immunodeficiency
For fingerstick whole blood virus infection and other sexually transmitted diseases, Sexually Transmitted Diseases 1992;
 Lancets  Heparinized capillary tubes and dispensing bulb
19:61-77
DIRECTIONS FOR USE
5. Johnson Phillip C.Testing for Syphilis, Dermatologic Clinic 1994; 12 Jan: 9-17
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior
to testing. Index of Symbols
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed Attention, see instructions Authorized
Tests per kit
pouch and use it as soon as possible. for use Representative
2. Place the test cards on a clean and level desk, then peel off the strip label of the test cards, stick For in vitro
Use by Do not reuse
the test dipstick onto it as soon as possible before testing. diagnostic use only
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or
plasma (approximately 40 L) to the specimen area, then add 1 drop of buffer (approximately 40 Store between 2-30°C Lot Number REF Catalog #
L),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of Do not use if package is
whole blood (approximately 80 L) to the specimen area, then add 1 drop of buffer damaged
(approximately 40 L), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
 To use a capillary tube: Fill the capillary tube and transfer approximately 80 L of fingerstick
whole blood specimen to the specimen area of test dipstick, then add 1 drop of buffer
(approximately 40 L) and start the timer. See illustration below.
 To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen
(approximately 80 L) to fall into the specimen area of test dipstick, then add 1 drop of buffer
(approximately 40 L) and start the timer. See illustration below. DN:
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after Rev. Date:
20 minutes.