inSTIcheck™ · STI rapid tests
inSTIcheck™ Syphilis Rapid Test
A lateral flow test device for the qualitative detection of antibodies to Treponema pallidum in whole blood, serum or plasma. The result is read at 10 minutes.
- Professional use
- Result in 10 minutes
- Whole blood, serum or plasma
- Treponemal antibody test
Intended use of the syphilis rapid test
The inSTIcheck™ syphilis rapid test is a rapid chromatographic immunoassay for the qualitative detection of antibody to Treponema pallidum in serum, plasma or whole blood. It is for professional in vitro diagnostic use, as an aid to diagnosis.
This is a treponemal antibody test. The insert warns that a positive result is not useful for establishing a diagnosis of syphilis, because in most situations such a result may reflect a prior treated infection. A negative result does not exclude incubating or early primary disease. A clinician must interpret every result with other clinical and laboratory findings.
First Diagnostic™ Corporation brands and distributes this test within its catalog of rapid tests.
Specifications
| Brand | inSTIcheck™ |
|---|---|
| Catalog number | 85226400105 (also ATF-112) |
| Format | Lateral flow test device with sample well, test area (T) and control area (C) |
| Analyte / target | Antibodies to Treponema pallidum |
| Specimen | Whole blood, serum or plasma |
| Sample volume | 20 µl (1 drop) of serum or plasma, or 40 µl (2 drops) of whole blood, then two drops of assay buffer |
| Time to result | Read at 10 minutes |
| Read window | Do not interpret the result after more than 30 minutes |
| Kit contents | Individually pouched test devices with pipettes; 1 assay buffer bottle |
| Storage | 4–30 °C in the sealed pouch; do not freeze |
| Intended user | Healthcare professionals |
| Regulatory | Documentation available on request |
| Insert document | Package insert version V.10012008 |
How the test works
The device is a membrane-based lateral flow test for antibody detection. Recombinant antigens are coated on the test area of the membrane and on colored particles.
When the specimen is applied to the sample well, it reacts with the antigen-coated colored particles. The mixture migrates toward the result window and reacts with the recombinant antigens in the test area. If the specimen contains antibodies to Treponema pallidum, a colored line appears in the test area. A colored line always appears in the control area if the test has been performed properly.
Test procedure at a glance
- Bring to room temperature. Allow the test device, assay buffer and specimen to reach room temperature (15–30 °C). Remove the device from the foil pouch, place it on a clean and level surface and use it as soon as possible.
- Add the specimen. Add 20 µl (1 drop) of serum or plasma, or 40 µl (2 drops) of whole blood, to the sample well of the test device.
- Add the buffer. Add two drops of assay buffer to the sample well and start the timer.
- Read the result. Read the result at 10 minutes. Do not interpret the result after more than 30 minutes. Discard the test device after reading and recording the result.
This summary does not replace the instructions for use supplied with the kit.
Reading results
- Reactive (preliminary positive): lines are visible in both the TEST (T) and CONTROL (C) areas, regardless of intensity. Treponemal antibodies have been detected in the specimen.
- Nonreactive (negative): one pink/purple line appears in the CONTROL (C) area and no line in the TEST (T) area. Treponemal antibodies were not detected; this does not exclude possible infection with syphilis.
- Invalid: no distinct line appears in the CONTROL (C) area. Insufficient specimen volume or incorrect procedural technique are the most likely reasons. Repeat with a new device.
For confirmation, the insert calls for further analysis of the specimen, such as ELISA and/or western blot.
Performance
inSTIcheck™ Syphilis Test Device compared with a commercial EIA test (ELISA) using clinical specimens (339 results), as printed in the product insert.
| inSTIcheck™ result | ELISA positive | ELISA negative | Total |
|---|---|---|---|
| Positive | 112 | 1 | 113 |
| Negative | 1 | 225 | 226 |
| Total | 113 | 226 | 339 |
Percentages printed in the insert: relative sensitivity 99.1%, relative specificity 99.6%. Source: product insert.
Limitations
- Antibody titers to treponemal antigens build gradually and may not be detected in early primary infection, so a negative treponemal test may not rule out syphilis.
- Once a patient has had syphilis, the specific antibody can remain indefinitely. A positive result may therefore indicate an earlier infection rather than active disease.
- The test indicates only the presence of antibodies to Treponema pallidum and should not be the sole criterion for diagnosis.
- The test is qualitative. Neither the quantitative value nor the rate of increase in antibodies can be determined.
- If the result is negative and clinical symptoms persist, follow-up tests using other clinical methods are recommended.
- Humidity and temperature can adversely affect results.
Downloads
The package insert supplied with the kit is the reference document for this test.
Frequently asked questions
How long can specimens be kept?
Finger stick whole blood should be tested immediately. Plasma or serum may be stored at 2–8 °C for up to 3 days, or below -20 °C for long-term storage. Whole blood collected by vein puncture into EDTA, citrate or heparin and stored at 2–8 °C should be used within three days.
How should the kit be stored?
Store the test device as packaged in the sealed pouch at 4–30 °C. Keep it in the pouch until use and do not freeze it.
What does the kit contain?
Individually pouched test devices with pipettes and 1 assay buffer bottle. The insert does not state the pack size; confirm it on your quotation.
What documentation is available?
The package insert is listed with our other product inserts and instructions for use. Regulatory documentation is available on request.
How do distributors order?
Complete the distributor application or email sales@firstdiagnostic.com with catalog number 85226400105 and the quantity you need.
Related rapid tests
- STI rapid tests — The full category of sexually transmitted infection tests.
- inSTIcheck™ Chlamydia rapid test — Detects chlamydia antigen in endocervical swab or urine specimens.
- inSTIcheck™ Gonorrhea rapid test — Detects Neisseria gonorrhoeae antigen in endocervical swab or urine specimens.
- ATFirst™ HIV / HBsAg / HCV combo rapid test — HIV 1/2 antibodies, HBsAg and HCV antibodies on one cassette with three test lines.
- Lateral flow tests explained — How lateral flow tests work and where they are used.
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Regulatory status: Products shown on this website are for professional in vitro diagnostic use. They are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States. Product availability and regulatory status vary by country; contact us for the status in your market.