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Candida albicans/Trichomonas vaginalis/Gardneralla vaginalis antigen Combo Test Kit (LFIA)
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Candida albicans/Trichomonas vaginalis/Gardneralla vaginalis antigen Combo Test Kit (LFIA)

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Candida albicans/Trichomonas vaginalis/Gardneralla vaginalis antigen Combo Test Kit (LFIA)

                 

Intended Use

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

 

Introduction

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.

Trichomoniasis is a sexually transmitted disease (STI) with important public health ramifications; it has been associated with vaginitis, cervicitis, urethritis, and pelvic inflammatory disease (PID). Trichomoniasis also impacts upon birth outcomes and is a co-factor in human immunodeficiency virus (HIV) transmission and acquisition.Trichomonas vaginalis is a motile organism with a size comparable to a white blood cell. It has at least 4 flagella that provide undulating motility. The organism resides in the lumen of the urogenital tract. The organism releases cytotoxic proteins that destroy the epithelial lining. During an infection, the vaginal pH usually increases.

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.

Storage Instructions

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, Trichomonas vaginalis 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.

 

 

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