Our syphilis home test kit is a convenient and accurate option for testing for this common STD from the comfort of your own home. The kit comes with everything you need, including a swab for collecting a sample and a dropper for transferring it to the testing strip. Simply follow the instructions provided and wait for your results, which are available in just minutes. This test is highly accurate and provides reliable results, giving you the information you need to seek treatment and protect your sexual health. Whether you are looking to take control of your sexual health or have been experiencing symptoms, our syphilis home test kit is an effective option.
Treponema Pallidum (TP) is the causative agent of the venereal disease syphilis. The antibody response to the TP bacterium can be detected within 4 to 7 days after the chancre appears.
TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane. Relatively little is known about the 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. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users. One study reported that a large number of HIV-infected females exhibited reactive syphilis serological test results. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of syphilis.
Product summary
- Detects syphilis (Treponema pallidum) antibodies.
- High clinical accuracy. Sensitivity: 98.1% specificity: 98%.
- For field & health care professional use.
- Tested by certified laboratories worldwide.
- ISO 13485 & GMP certifications.
- Discreet shipping from NY.
- EASY TO USE: It is fully certified for use in the comfort of your own home, this saves going to the clinic and in most cases waiting for 2 weeks for your result. All you need is included in the package.
- FAST AND ACCURATE: This test kit is the fastest and most accurate among its competitors on the market. It will give you your result in just 10 minutes.
- PACK DIMENSIONS: 16 x 8 x 2.5cm
- DURABLE: Meets all QC specifications.
- CONTENTS: Pack of 2 Syphilis Home Tests – They come in one pack and each test is individually bagged to make sure no tampering has been done.
Product Description
CATALOG
| Product Name | Specimen | Catalog No. | Quantity per box |
| Syphilis Strip | Whole Blood/Serum/Plasma | ABT-STD-A60 | 50T |
| Syphilis Cassette | Whole Blood/Serum/Plasma | ABT-STD-B60 | 25T |
KEY POINTS
Detection for: antibodies (IgG and IgM) to Treponema Pallidum (TP) qualitatively in whole blood.Serum or plasma.
Specimen volume:
For test strip: Serum or Plasma Specimen: 50μL
Venipuncture or Fingerstick Whole Blood specimen: 50μL
For test cassette: Serum or Plasma specimen:40μL
Venipuncture or Fingerstick Whole Blood Specimen:80μL
Reading time: 10 minutes
Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);
Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);
Accuracy: 99.8% (95%CI*: 98.2%~100.0%).
INTRODUCTION
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. Relatively little is known about the organism in comparison with other bacterial pathogens.
INTENDED USE
Parsagen® Syphilis Rapid Test Strip/Cassette (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.
TEST PROCEDURE
Test strips:
Test Cassette:
1. Remove the test strip from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Peel off the tape from the test card, and stick the test strip in middle of the test card with arrows pointing downwards as illustrated.
3. Place the Strip/Cassette on a clean and level surface.
For test strip
For Serum or Plasma specimen: Hold the dropper vertically and transfer 2 drop of serum or plasma (approximately 50μL) to the Specimen Pad of the test strip, then add 1 drop of buffer (approximately 40μL) and start the timer.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) onto the Specimen Pad of the test strip, then add 1 drop of buffer (approximately 40μL), and start the timer.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 μL of fingerstick whole blood specimen to the specimen area of test strip, then add 1 drop of buffer (approximately 40μL) and start the timer.
For test cassette:
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40μL) to the specimen area, then add 1 drop of buffer (approximately 40μL),and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80μL) to the specimen area, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 80μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 30 minutes.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
Parsagen® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of a performance panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens. The results show that the relative sensitivity of Parsagen® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) is >99.9% and the relative specificity is 99.7%.
| Method | TPPA | Total Result | ||
| Parsagen® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) | Results | Positive | Negative | |
| Positive | 130 | 1 | 131 | |
| Negative | 0 | 299 | 299 | |
| Total Result | 130 | 300 | 430 | |
Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);
Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);
Accuracy: 99.8% (95%CI*: 98.2%~100.0%).
*Confidence Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 10 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of Parsagen® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) have been tested over a 3-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.
Cross-reactivity
Parsagen® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV,HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.
Interfering Substances
The following potentially interfering substances were added to Syphilis negative and positive specimens.
Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
Ascorbic Acid: 2g/dL Albumin: 2 g/dL
Creatin: 200 mg/dL Hemoglobin 1.1 mg/dL
Bilirubin: 1g/dL Oxalic Acid: 600mg/dL
None of the substances at the concentration tested interfered in the assay.
LIMITATIONS
1. Parsagen® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of TP antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in TP antibodies can be determined by this qualitative test.
2. Parsagen® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of TP antibodies in the specimen and should not be used as the sole criteria for the diagnosis of TP infection.
3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of TP infection.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.