The Candida albicans/Tv/Gv antigen rapid test is a membrane-based immunochromatographic assay developed for the qualitative detection of vaginal pathogens from vaginal swab samples.
Vaginal infections are frequently caused by:
Candida albicans (vulvovaginal candidiasis – VVC)
Trichomonas vaginalis (Tv) (trichomoniasis – a common non-viral STI)
Gardnerella vaginalis (Gv) (bacterial vaginosis – BV)
Conventional diagnostic methods such as microscopy and culture may demonstrate limited sensitivity or require prolonged turnaround times. This rapid antigen test offers results within 15 minutes, significantly improving workflow efficiency and enabling immediate clinical action.
The assay operates on a capillary-driven chromatographic principle. When extracted specimen is applied to the sample well:
Target antigens bind to colloidal gold-labeled antibodies.
Immune complexes migrate along the membrane.
Complexes are captured at the CA, TV, or GV test lines.
A colored control line (C) confirms procedural validity.
The test is intended as a screening tool and as an aid in diagnosis. Reactive results must be confirmed using alternative diagnostic methods and correlated with clinical findings, in accordance with the IFU.
The EZER™ Candida albicans/Tv/Gv Antigen Combo Rapid Test includes:
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
This triple-pathogen capability makes it a powerful tool for comprehensive vaginitis screening and differential diagnosis.
Vaginitis is commonly caused by fungal, protozoal, or bacterial pathogens. Because symptoms often overlap, accurate laboratory differentiation is essential.
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.
Produced by Hangzhou Genesis Biodetection & Biocontrol Co., Ltd., the EZER™ Candida albicans/Tv/Gv antigen rapid test demonstrates strong 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%
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.
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.
Bring all components to room temperature (15–30°C).
Add 20 drops of sample buffer into the extraction tube.
Insert the vaginal swab and mix vigorously (at least 10 rotations).
Allow the swab to soak for 2 minutes.
Remove swab while squeezing the tube to retain liquid.
Attach extraction tube tip.
Add 3 drops (~100 µL) to the specimen well.
Wait 15 minutes.
Do not interpret results after 20 minutes.
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.
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.
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