inSTIcheck™ · STI rapid tests
inSTIcheck™ Gonorrhea Rapid Test
An antigen test in cassette format for the qualitative detection of Neisseria gonorrhoeae in endocervical swab or urine specimens, read at 5 minutes. For professional in vitro diagnostic use.
- Professional use
- Antigen test
- Read at 5 minutes
- CE marked
Intended use
The inSTIcheck™ gonorrhea rapid test from First Diagnostic™ Corporation is a rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae directly from endocervical swab or urine specimens. It is an antigen test and does not detect antibodies in blood.
It is for professional in vitro diagnostic use, to aid in the diagnosis of gonorrhea infection. The insert treats positive and negative results as presumptive, to be used only as an adjunct to other information available to the physician. See the full STI rapid tests range in our rapid tests catalog.
Specifications
| Brand | inSTIcheck™ |
|---|---|
| Catalog number | 85226400035 |
| Format | Lateral flow cassette (rapid chromatographic immunoassay), qualitative |
| Target | Neisseria gonorrhoeae antigen |
| Specimen | Endocervical swab or urine. The insert also describes male urethral swab collection, and states that performance with other clinical specimens has not been determined. |
| Sample volume | 4 drops of extracted solution into the sample well (S) |
| Time to result | Read at 5 minutes |
| Read window | Do not read after 15 minutes |
| Kit sizes | 20, 40 or 100 tests |
| Kit contents (as listed in the insert) | Individually pouched test devices and pipettes; Buffer A; Buffer B (the Reagents A/1 and B/2 of the procedure); sterile urethral swabs; positive control; negative control; package insert. The insert’s quality control section says control standards are not supplied, so confirm at quotation. |
| Required but not provided | Centrifuge tube (urine specimens only) |
| Storage | 2–30 °C (see kit label), in the sealed pouch. Do not freeze. |
| Intended user | Healthcare professionals |
| Regulatory | CE marked (as shown on the product insert) |
| Insert document | inSTIcheck™ Gonorrhea package insert, product code 85226400035 |
How the gonorrhea rapid test works
The cassette is a qualitative lateral flow immunoassay that captures antigen rather than antibody. Antigen is extracted from the specimen with two reagents, and the extracted solution reacts with particles coated with an antibody to the gonorrhea antigen.
The mixture migrates along the membrane to the test line, where an antibody specific to the antigen is coated; a colored line there indicates a positive result. A colored control line confirms that the proper volume of specimen was added and that membrane wicking occurred. Our guide to lateral flow tests explains the principle.
Test procedure at a glance
Swab procedure, summarized from the insert.
- Prepare. Bring the device, buffers and specimen to room temperature (18–30 °C). For urine, centrifuge 15 mL of first-void urine at 1,500–3,000 rpm for 15 minutes, discard the supernatant and use the precipitate.
- Extract with Reagent A. Dispense 5 drops (200 µL) of Reagent A into the reaction tube, add the swab, mix thoroughly and let it stand for 2 minutes at room temperature.
- Add Reagent B. Dispense 2 drops (80 µL) of Reagent B and mix well with the swab. Squeeze the excess liquid from the swab into the tube and discard the swab.
- Load the cassette. Add 4 drops of the extracted solution to the sample well (S) with the transfer pipette.
- Read the result. Interpret at 5 minutes. Do not read after 15 minutes.
This summary does not replace the instructions for use supplied with the kit.
Reading results
- Positive: red bands appear in both the control area and the test area. Any shade of red (not grey) in the test region (T) is read as positive, even if faint.
- Negative: one red band appears in the control area only.
- Invalid: no line forms in the control window. The directions may not have been followed correctly or the test may have deteriorated; re-test the specimen.
Performance
Performance characteristics against the comparator method are given in the product insert, available on the product inserts page.
The insert also lists organisms that gave negative results with the device, including Chlamydia trachomatis, Neisseria meningitidis, Neisseria lactamica, Gardnerella vaginalis and Candida albicans.
Limitations
- A negative result cannot be used to exclude infection with N. gonorrhoeae. It can follow inadequate specimen collection, inappropriate specimen storage or antigen levels below the limit of detection. If symptoms persist or intensify, repeat the test.
- Positive results are presumptive; additional evidence should be used to identify N. gonorrhoeae infection. Interpret positives in a low-risk or low-prevalence population with caution.
- Antigen detection does not require viable organisms, so the test may be positive in the absence of living organisms.
- Monoclonal antibodies may not detect all strains of N. gonorrhoeae.
- As with other non-culture methods, the test should not be used in the investigation of suspected sexual abuse or for other medical-legal indications.
Downloads
The package insert contains the full instructions for use, quality control guidance and performance characteristics.
Frequently asked questions
Is this an antigen test or an antibody test?
An antigen test. It detects Neisseria gonorrhoeae antigen extracted from an endocervical swab or urine specimen. It does not detect antibodies and is not run on blood.
Which kit sizes are available, and how are kits stored?
The insert lists kits of 20, 40 and 100 tests. Store in the sealed pouch at 2–30 °C (see kit label), away from sunlight, moisture and heat. Do not freeze.
Are controls included?
Each cassette has a built-in control line. The insert recommends running positive and negative controls as good laboratory practice; ask us whether external controls are supplied with the kit you order.
How can we order or become a distributor?
Email sales@firstdiagnostic.com for a quotation, or complete the distributor application. First Diagnostic supplies customers outside the United States.
Related rapid tests
- STI rapid tests — The inSTIcheck™ and ATFirst™ range for sexually transmitted infections.
- inSTIcheck™ Chlamydia rapid test — Antigen cassette for Chlamydia in swab or urine specimens.
- inSTIcheck™ Syphilis rapid test — Antibodies to Treponema pallidum in whole blood, serum or plasma.
- Lateral flow tests explained — How lateral flow cassettes work.
Request a quote for the inSTIcheck™ Gonorrhea rapid test
First Diagnostic brands and distributes lateral flow rapid tests made by established IVD manufacturers. Tell us your market, kit size and volume, and we will reply with pricing and documentation.
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.