Candida albicans/Tv/Gv – EZER™ Antigen Test

What is in the Candida albicans/Tv/Gv Rapid Test?

The EZER™ Candida albicans/Tv/Gv Antigen Combo Rapid Test includes:

Kit Components:

• 20 Test devices

• 2 vials of Sample Buffer (10 mL each)

• 20 Sterile vaginal swabs

• 20 Extraction tubes

• 20 Extraction tube tips

• 1 Tube stand

• 1 Package insert

The test detects three major vaginal pathogens from a single vaginal swab specimen. Each pathogen is identified through a dedicated test line:

• CA – Candida albicans antigen

• TV – Trichomonas vaginalis antigen

• GV – Gardnerella vaginalis antigen

The three test lines together cover the differential diagnosis of vaginitis in one device.

Role of Candida albicans, Trichomonas vaginalis and Gardnerella vaginalis in Vaginal Diagnosis

Vaginitis is commonly caused by fungal, protozoal, or bacterial pathogens. Because symptoms often overlap, accurate laboratory differentiation is essential.

Pathogen Profiles:

Candida albicans –
Responsible for approximately 80% of vulvovaginal candidiasis (VVC) cases. Symptoms include itching, irritation, soreness, and genital burning. Microscopy sensitivity may be as low as 50%, leading to missed diagnoses.

Trichomonas vaginalis –
The most common non-viral sexually transmitted infection worldwide. Conventional wet mount microscopy shows reported sensitivity of approximately 58% compared to culture.

Gardnerella vaginalis –
An anaerobic bacterium associated with bacterial vaginosis (BV). Overgrowth disrupts normal Lactobacillus-dominant vaginal flora and is linked to the presence of clue cells on microscopy.

Because these infections present with similar clinical symptoms, simultaneous antigen detection ensures accurate identification and appropriate treatment decisions.

About the EZER™ Candida albicans/Tv/Gv Antigen Rapid Test Device

Produced by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd., the EZER™ Candida albicans/Tv/Gv antigen rapid test demonstrates strong clinical performance:

Clinical Performance:

Candida albicans

• Relative Sensitivity: 92.3%

• Relative Specificity: 98.6%

• Overall Accuracy: 97.6%

Trichomonas vaginalis

• Relative Sensitivity: 99.6%

• Relative Specificity: 100%

• Overall Accuracy: 99.92%

Gardnerella vaginalis

• Relative Sensitivity: 92.3%

• Relative Specificity: 98.6%

• Overall Accuracy: 97.6%

Detection Limits:

• Candida albicans: 1.4 × 10⁵ CFU/mL

• Trichomonas vaginalis: 1.17 × 10⁴ cells/mL

• Gardnerella vaginalis: 1.07 × 10⁵ CFU/mL

No cross-reactivity was observed with organisms such as Neisseria gonorrhoeae, Chlamydia trachomatis, Escherichia coli, Staphylococcus aureus, Mycoplasma hominis, and others tested at 10⁶ CFU/test.

The test also showed no interference at the following concentrations:

• Whole blood: 4%

• Mucin: 0.3%

• Urine: 4%

• Nystatin: 5 mg/mL

• Miconazole: 5 mg/mL

• Tinidazole: 5 mg/mL

• Metronidazole: 5 mg/mL

• Vaginal lotions: 2% v/v

Its built-in procedural control line ensures assay validity, making this multiplex vaginitis-targeted assay both robust and dependable for routine clinical use.

Principle and Workflow

The Candida albicans/Tv/Gv Antigen Test is a qualitative, membrane-based lateral flow immunoassay.

When an extracted vaginal specimen is applied to the sample well:

• Target antigens bind to colloidal gold-labeled antibodies.

• Immune complexes migrate along the membrane by capillary action.

• Complexes are captured at specific test zones (CA, TV, GV).

• A colored control line (C) confirms procedural validity.

Procedure:

1. Bring all components to room temperature (15–30°C).

2. Add 20 drops of sample buffer into the extraction tube.

3. Insert the vaginal swab and mix vigorously (at least 10 rotations).

4. Allow the swab to soak for 2 minutes.

5. Remove swab while squeezing the tube to retain liquid.

6. Attach extraction tube tip.

7. Add 3 drops (~100 µL) to the specimen well.

8. Wait 15 minutes.

9. Do not interpret results after 20 minutes.

Result Interpretation:

CA Line Visible: Candida albicans positive

TV Line Visible: Trichomonas vaginalis positive

GV Line Visible: Gardnerella vaginalis positive

Multiple Lines Visible: Co-infection detected

Negative: Only control line visible

Invalid: No control line, repeat with new device

Any shade of red in a test line region must be considered positive.

Clinical Application

The Candida albicans/Tv/Gv Antigen Test is ideal for:

• Gynecology clinics diagnosing vaginitis

• Sexual health clinics screening STI-related infections

• Clinical microbiology laboratories

• Primary care settings requiring rapid differentiation

• Point-of-care environments lacking culture capacity

Its triple-pathogen detection approach enables accurate differentiation of fungal, protozoal, and bacterial causes of vaginal infection using a single swab and a single cassette.

In environments where microscopy sensitivity is limited or culture turnaround is delayed, the EZER™ Candida albicans Trichomonas vaginalis Gardnerella vaginalis Antigen Rapid Test serves as a practical and efficient diagnostic solution.