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Candida albicans/Gardnerella vaginalis antigen Combo Test Kit (LFIA)
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Candida albicans/Gardnerella vaginalis antigen Combo Test Kit (LFIA)

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Intended Use

Candida albicans/Gardnerella vaginalis antigen Combo Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of Candida albicans and Gardnerella vaginalis in female vaginal swab samples in vitro.

 

Summary

Candida albicans is a major fungal pathogen of humans. It exists as a commensal in the oral cavity, gut or genital tract of most individuals, constrained by the local microbiota, epithelial barriers and immune defences. Their perturbation can lead to fungal outgrowth and the development of mucosal infections such as oropharyngeal or vulvovaginal candidiasis, and patients with compromised immunity are susceptible to life-threatening systemic infections.

Gardnerella vaginalis is an anaerobic bacterium that resides in the normal vaginal flora. Normally, vaginal flora is predominated by the Lactobacilli species, but when organisms such as Gardnerella begin to overgrow and become the dominant species, this leads to bacterial vaginosis (BV). Bacterial vaginosis is characterized by the presence of clue cells, which are epithelial cells of the cervix that are covered with rod-shaped bacteria.

 

 

Test principle

Candida albicans/Gardnerella vaginalis antigen Combo Test Kit (LFIA) uses a double antibody sandwich method to detect Candida albicans and Gardnerella vaginalis by colloidal gold immunochromatography.

When the appropriate amount of test samples treated with lysis buffer is added to the sample well of the test cassette, the sample will move forward along the test strip by capillary action. If the sample contains Candida albicans and Gardnerella vaginalis antigen, and the concentration is higher than the limit of detection, the antigen will form immune complexes with corresponding Candida albicans or Gardnerella vaginalis antibody labeled with colloidal gold respectively, which are captured by CA line and GV line. If test sample contains Candida albicans, forming a red CA

line, indicating a positive result for Candida albicans. If test sample contains Gardnerella vaginalis , forming a red GV line, indicating a positive result for Gardnerella vaginalis .

Additionally, the test strip also contains a control line (C line). The C line should be formed to indicate that the sample has been transported properly through the membrane regardless of whether sample contains antigens or not. If the C line does not appear, it indicates that the test result is invalid and the sample need to retest.

 

Test Kit Contents

Specification

Test Cassette

Lysis Buffer and Dropper

Sampling swab

Instructions For use

1 pc/Bag

1

1

1

1

Test cassette: contains the Candida albicans and Gardnerella vaginalis test strip and a plastic cassette casing.

Candida albicans and Gardnerella vaginalis test strip contains

anti-Candida albicans antibody labeled with colloidal gold, anti-Gardnerella vaginalis antibody labeled with colloidal gold. Another anti-Candida albicans antibody and anti-Gardnerella vaginalis antibody are fixed on the CA line and GV line respectively. The CA line and GV line and control line (C line) are in the detection window on the nitrocellulose membrane.

 

Storage conditions and validity period

The test kit should be stored away from direct sunlight at 2℃ to 30 with a shelf-life of 24 months. Do not freeze.

 

 

Sample requirements

  1. Secretions were obtained from the posterior vaginal fornix with cotton swabs.
  2. Sample should be transferred into the lysis buffer provided in this kit as soon as possible after collection.

 

Testing Procedure

Insert the swab (after collection) into the sampling tube containing dilution buffer. Rotate the swab against the inner tube wall 10 times and squeeze the swab from the outer tube wall 5 times to completely dissolve the sample in the buffer, then move the swab up until it is resting on the sample solution, squeeze the swab from the outer tube wall in order to leave the sample in the tube as much as possible. Remove and discard the swab, cover the tube with the dropper. Open the aluminum foil pouch, take out the test cassette and lay it on a clean flat surface, add 4 drops (approximately 100 μL) processed sample extract into the sample well. The result should be observed within 15-20 minutes. Result observed after 20 minutes is invalid.

 

Test method limitations

  1. The accuracy of the test is dependent on the quality of the sample. Improper sampling or storage, using expired samples or repeated frozen-thawed samples can affect the test result. Test results can also be affected by temperature and humidity.
  2. Negative results may be caused by low concentration of Candida albicans and Gardneralla vaginalis antigens in the sample and therefore cannot completely rule out the possibility of infection.
  3. This product is only for qualitative testing and the specific concentration of each indicator must be measured using other quantitative methodologies.
  4. The results of this test are for clinical reference only and should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods.

 

Display of Results/Expected Values

Negative result: If only the quality control C line appears and the detection T line is not visible, the sample contains no  Candida albicans, Trichomonas vaginalis and Gardneralla 

  1. vaginalis antigens or the concentration is lower than the limit of detection and the result is negative.
  2. Positive result: If the quality control C line appears, and one or more red lines appear in the T1T2T3 detection line area, indicating that the sample contains one or more pathogenic microorganisms.
  3. Invalid result: If the C line does not appear, the result is invalid and a new test must be performed.

Note:  The color intensity of the T line is related to the concentration of carbapenemase in the sample, the result should be determined by whether the T line is colored or not regardless of the color intensity.

 

Product performance

·Limit of Detection-LoD

Limit of Detection (LoD) studies determined the lowest detectable concentration of the Candida albicans and Gardneralla vaginalis, which ≥95% of all (true positive)  replicates test positive.

The LoD of Candida albicans is 105CFU/mL; the LoD of Gardneralla vaginalis is 105CFU/mL.

 

·Cross Reactivity

Cross reactivity and potential interference of Candida albicans/Gardnerella vaginalis antigen Combo Test Kit (LFIA) were evaluated by testing microorganisms in the absence or presence of Candida albicans and Gardneralla vaginalis. The listed items in the following table may be present in the clinical samples. Each of the bacterium and yeast was tested in triplicate with no false positive results.

 

Protential Cross-Reactant

Concentration

Tested

Cross-Reactivity

(Yes/No)

Neisseria gonorrhoeae

1.0×106CFU/mL

No

Mycoplasma hominis

1.0×106CFU/mL

No

Chlamydia trachomatis

1.0×106CFU/mL

No

Acinetobacter

1.0×106CFU/mL

No

Ureaplasma urealyticum

1.0×106CFU/mL

No

 A hemolytic streptococcus

1.0×106CFU/mL

No

Group A Streptococcus

1.0×106CFU/mL

No

Proteus vulgaris

1.0×106CFU/mL

No

 A hemolytic streptococcus

1.0×106CFU/mL

No

Group B Streptococcus

1.0×106CFU/mL

No

Staphylococcus epidermidis

1.0×106CFU/mL

No

Escherichia coli

1.0×106CFU/mL

No

Shigella dysenteriae

1.0×106CFU/mL

No

B hemolytic streptococcus

1.0×106CFU/mL

No

human papillomavirus

1.0×106CFU/mL

No

Staphylococcus aureus

1.0×106CFU/mL

No

 

·Interfering Substances Effect

A study was performed to evaluate and demonstrate that the endogenous substances naturally present or drugs that may be artificially introduced into clinical samples do not inference with the detection of carbapenemases in the Medomics  Candida albicans/Gardneralla vaginalis antigen Combo Test Kit (LFIA) at the concentrations listed below. Test the listed items in the absence or presence of Candida albicans  and Gardneralla vaginalis.

Potential Interfering Substances

Concentration

Interference(Yes/No)

Whole blood

50ul/mL

No

Mucin

10mg/mL

No

Urine

50ul/mL

No

Mycostatin (suppository)

5mg/mL

No

Miconazole

5mg/mL

No

tinidazole (gel)

5mg/mL

No

Metronidazole (gel)

5mg/mL

No

Jieeryin (lotion)

20ul/mL

No

Fuyinjie (lotion)

20ul/mL

No

Hemoglobin

10mg/mL

No

 

Warnings and Precautions

1. Please read the manual carefully before operation, and please test in strict accordance with the requirements of the manual.

2. This test kit is used for in vitro diagnosis only.

3. This test kit should be used within 1 hour after opening the foil pouch.

4. The test results of this kit are for clinical reference only and are not the sole basis for clinical diagnosis. The clinical diagnosis and treatment of patients should be comprehensively considered in combination with their symptoms/signs, medical history, other laboratory tests and treatment response.

5. This product is for one-time use, please do not reuse.

6. Do not use if damaged.

7. After the test, the used test cards, etc. should be disposed of as medical waste.

 

Reference

1. François L Mayer, Duncan WilsonBernhard Hube. Candida albicans pathogenicity mechanisms. Virulence. 2013 Feb 15;4(2):119-28.

2.António Machado and Nuno Cerca. Influence of Biofilm Formation by Gardnerella vaginalis and Other Anaerobes on Bacterial Vaginosis. J Infect Dis. 2015 Dec 15;212(12):1856-61.

 

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