NOVAtest LOGO

Menu Search

Gonorrhea Test Kits

Gonorrhea antigen rapid test, Gonorrhea IgG and IgM Dot Assay kits are rapid test kits used as an aid in the diagnosis of gonococcus infection.

Gonorrhea Rapid Test Kit

Intended Use

Gonorrhea antigen rapid test strip and Gonorrhea test cassette are immunoassay for the detection of gonorrhea antigens in the secretory specimen and urine from urogenital system; while Gonorrhea IgG and IgM Dot Assay kits are for the detection of IgG and IgM antibodies specific to gonococcus virus. All these Gonorrhea test kits are rapid test kits used as an aid in the diagnosis of gonococcus infection.

Why Gonorrhea Testing Matter

With early diagnosis and antibiotic treatment, STD gonorrhea can be cured. The earlier the treatment actions are taken, the easier it is to be cured, and less lesions will occur. So the early diagnostics are important to the treatment of this disease. In developed countries, regular screening test are recommended for the women active at sexual action. Rapid test kits such as NGH rapid test cassette and NGH antibody dot test kit are a good choice for this purpose.

There is a close connection between gonorrhea and other sexually transmitted infections, such as Chlamydia, syphilis and HIV infection. For example, studies prove that 50% of the persons who infected with gonorrhea also are infected with Chlamydia. So, all the patients who have tested positive for gonorrhea should test for other sexually transmitted diseases such as Chlamydia, syphilis and HIV.

Gonorrhea Disease

Gonorrhea is a serious sexually transmitted disease (STD) caused by bacteria called Neisseria gonorrhoeae. After Chlamydia, gonorrhea is regarded as the second most common STD.

Infected women are asymptomatic half the time or have vaginal discharge and pelvic pain. The common symptoms in men are burning with urination and penile discharge. If gonorrhea is left untreated, it may spread all over the body, causing epididymitis or pelvic inflammatory disease, affecting joints and heart valves, and can cause infertility in as many as 10% of infected women.

Newborn infants can be infected during delivery, which causes eye infections in neonates and can eventually leads to blindness.

Gonorrhea Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
NGH 321 Gonorrhea Antigen Test Strip Urogenital Swab 100 Bulk: 5500 PCS
Boxed: 40 Boxes
NGH 322 Gonorrhea AG Test Cassette Urogenital Swab 25 Bulk: 1100 PCS
Boxed: 40 Boxes
NGH 3212 Gonorrhea IgM Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
NGH 3222 Gonorrhea IgG Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
How to Use

Gonorrhea Antigen Test Strip

General Information

(IVD Kit »-» Sexually Transmitted Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:NGH 321
Description:Gonorrhea Antigen Test Strip
Category:Sexually Transmitted Disease
Style:Dipstick
Unit:PCS
Specimen:Urogenital Swab
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:100 bacterium/ul
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98.7%
Specificity:99.2%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):5500 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.5 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Gonorrhea Antigen Test strip in single pouch with desiccant;
  • Specimen Diluents 1;
  • Specimen Diluents 2;
  • Instruction leaflet for use.

Specimen

Female endocervical specimen

Before specimen collection, use a swab or cotton ball to remove excess mucus from the endocervical area and discard.

Use the swab provided along the kit or any shafted swabs with rayon or Dacron tips. The swab should be inserted into the endocervical canal past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells which are the main reservoir of the organism to detect. Firmly rotate the swab for 15-20 seconds and withdraw without contamination of extra-cervical or vaginal cells.

Alternatively, endocervical specimens can be collected with a cytology brush (Not provided. Caution: do not use cytology brushes with pregnant patients). Insert the cytology brush into the endocervical canal past the squamocolumnar junction. Leave the brush still for two to three seconds. Rotate the cytology brush two full turns, and withdraw the brush without touching any vaginal surface.

Place the swab in the extraction tube, and carry out the test immediately.

Male Urethral specimen

Use standard wire-shafted fiber-tipped swabs for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection.

Insert the swab into the urethra about 2-4cm, rotate for 3-5 seconds and withdraw it.

Place the swab to the extraction tube, and carry out the test immediately.

Urogenital Swab Storage Condition

If immediate testing is not possible, the patient sample should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4 hours at room temperature (15-30℃) or 24 hours at refrigerated (2-8℃). Do not freeze.

All specimens should be allowed to reach a room temperature of 15-30℃ before testing.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Gonorrhea AG Test Cassette

General Information

(IVD Kit »-» Sexually Transmitted Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:NGH 322
Description:Gonorrhea AG Test Cassette
Category:Sexually Transmitted Disease
Style:Card
Unit:PCS
Specimen:Urogenital Swab
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:100 bacterium/ul
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98.7%
Specificity:99.2%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1100 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Gonorrhea Ag Test Cassette in single pouch;
  • Specimen Diluents 1;
  • Specimen Diluents 2;
  • Plastic Pipette for sample transfer;
  • Instruction leaflet for use.

Specimen

Female endocervical specimen

Before specimen collection, use a swab or cotton ball to remove excess mucus from the endocervical area and discard.

Use the swab provided along the kit or any shafted swabs with rayon or Dacron tips. The swab should be inserted into the endocervical canal past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells which are the main reservoir of the organism to detect. Firmly rotate the swab for 15-20 seconds and withdraw without contamination of extra-cervical or vaginal cells.

Alternatively, endocervical specimens can be collected with a cytology brush (Not provided. Caution: do not use cytology brushes with pregnant patients). Insert the cytology brush into the endocervical canal past the squamocolumnar junction. Leave the brush still for two to three seconds. Rotate the cytology brush two full turns, and withdraw the brush without touching any vaginal surface.

Place the swab in the extraction tube, and carry out the test immediately.

Male Urethral specimen

Use standard wire-shafted fiber-tipped swabs for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection.

Insert the swab into the urethra about 2-4cm, rotate for 3-5 seconds and withdraw it.

Place the swab to the extraction tube, and carry out the test immediately.

Urogenital Swab Storage Condition

If immediate testing is not possible, the patient sample should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4 hours at room temperature (15-30℃) or 24 hours at refrigerated (2-8℃). Do not freeze.

All specimens should be allowed to reach a room temperature of 15-30℃ before testing.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Gonorrhea IgM Dot Assay

General Information

(IVD Kit »-» Sexually Transmitted Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:NGH 3212
Description:Gonorrhea IgM Dot Assay
Category:Sexually Transmitted Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA Capture

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of DGFIA Capture

DGFIA Capture Method Illustration

For the detection of IgM-class antibodies, capture technique has its advantage in that it can reduce the interference from the IgG class, thus increase the specificity of the test kit.

In a capture dot filtration test kit, antibodies directed to human IgM antibody (anti-i chain) are pre-coated in the test region on the millipore filtering membrane. When specimen is added, the IgM, if present, will be captured by this secondary antibody, anti-IgM.

After washing away the specimen, especially the IgG antibody, the antigen conjugated with colloidal gold particle will be added. If the IgM antibody was captured in the prior step, the IgM will bind to the antigen conjugate. When the colloidal gold particles congregate, a red or pink color will develop, indicating a positive result.

If no IgM in the specimen, this complex will not develop, the antigen conjugated colloidal gold particles will not congregate, and no color will develop in the test region, indicating a negative result.

Information | Packing | Specimen | Principle

Gonorrhea IgG Dot Assay

General Information

(IVD Kit »-» Sexually Transmitted Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:NGH 3222
Description:Gonorrhea IgG Dot Assay
Category:Sexually Transmitted Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of DGFIA indirect

DGFIA Indirect Method Illustration

With indirect Dot filtration test kit, the millipore filtering membrane is pre-coated with purified or recombinant viral antigens. The detecting conjugate reagent is stored in a vial, whose main component is rabbit anti human IgG (anti-IgG) antibodies, which is conjugated with colloidal gold particles.

During the first step, sample is added to the sample well in the test cassette. The target IgG antibodies, if present, will be captured by the pre-coated antigens.

The wells are washed to remove unbound serum proteins. Then, the colloidal gold conjugate is added. If the target IgG antibodies have been captured in the first step, the IgG antibody will react with the added secondary antibody, anti-IgG conjugate, and red color will develop, indicating a positive result.

Information | Packing | Specimen | Principle