【Product Name】Detection Kit for Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis antigen (latex chromatography) (latex chromatography)

【Registration Number】State Food and Drug Administration Machinery (quasi) No. 20163401110

【Packing】 25 doses / box, 50 doses / box.

【Storage conditions and validity】It will keep for 12 months if store in ventilated, dry, cool, away from heat, non-corrosive gases indoors at 2 ~ 30 ℃. Reagent card from the aluminum foil bag must be used to test within 1       hour, and the test should be at room temperature (15 ~ 30 ℃), the relative humidity is less than 80%.

 

This kit is suitable for the determination of candida albicans/vaginal trichomonas vaginalis/vaginella antigens in the female vaginal secretions.

vaginal candidiasis is one of the most common female vaginitis and mainly caused by infection of candida albicans, (CA). Candida vaginitis is the most common vaginal diseases second only to the bacterial vaginal disease. Candida vaginitis is more harmful to pregnant women due to its characteristics of difficult to cure and easy to repeated. Some complication rates can be increased such as rupture of embryolemma, amniotic fluid contamination, premature birth and intrapartum and postpartum infection, which causing premature birth, fetal infection, deformity and threatening maternal and child health.

Trichomonas vaginalis is a common disease in gynecology. It is caused by the infection of trichomonas vaginalis (TV). Trichomonas vaginalis is eukaryotes with flagella which is parasitic on the human vagina and urinary tract. Trichomonas vaginalis infection is a common non-viral reproductive tract infection and is one of the most popular sexually transmitted diseases. It is associated with many perinatal complications, infections of male and female genital tract and the morbidity raises of HIV.

Bacterial vaginal disease (Bacterial Vaginosis, BV) is a common clinical syndromeone in women of childbearing age. It is characterized by the transition of microbial flora of reproductive tract. Lactobacillus is replaced by high concentrations of Gardnerella vaginalis and a series of potentially pathogenic microorganisms associated with bacterial vaginal disease. Vaginal bacterium is one of the main pathogens of bacterial vaginal disease, it cause diseasesn such as urethritis, endometritis, cervical epithelial atypical hyperplasia. Pregnant women with vaginal Gardner fungus infection can be attacked by a series of complications such as premature delivery, premature rupture of membranes, chorioamnionitis, puerperal infection, low birth weight, the increase of susceptibility to HIV.

In conclusion, It is important and far-reaching to timely and accurately diagnose and identify the diseases of candida vaginitis, trichomonas vaginitis and bacterial vaginal and take effective treatment measures, which can improve the level of national health, especially the female reproductive health level.

The kit uses latex immunochromatography to coat Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis at the detection line (T) on the nitrocellulose membrane and coat biotin-BSA on the position of quality control line (C). Moreover, it could immobilize red latex particle-labeled Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis and blue latex particle-labeled streptavidin on the latex conjugate pad. When testing positive samples, Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis antigen in samples bind to the red latex labeled Calbicans / Trichomonas vaginalis / Gardnerella vaginalis specific antibody on the latex conjugate pad and form a complex. This complex could move along the membrane under the action of chromatography. Upon passing through the test line, it reacts with the pre-coated Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis antibody and form a red band, at the quality control line, blue latex particle-labeled streptavidin on the latex conjugate pad binds to biotin-BSA to form a blue band. For the detection of negative samples, the negative sample shows blue only at the control line (C). Therefore, a blue band appears at the quality control line (C) regardless of whether Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis antigen is present in the clinical specimen. The blue band appearing at the control line (C) is the standard for judging whether there are enough specimens and whether the chromatographic process is normal. At the same time, it is used as the internal control standard of reagents.

1. It can distinguish the three most important pathogenic pathogens, (gardneri/white/trichomoniasis) with a sample and one test.

2. It can directly distinguish the multiple infections of the three main pathogens and the traditional methods (microscopic examination and enzymatic chemistry) can not achieve.

3. It is not affected by the medication of patients, and the target pathogen can be selected.

4. It can assist the doctor to guide the medication, to bring better therapeutic effect to the patient, especially for the intractable, recurrent vaginal disease.

5. It can improve the accurate diagnosis of patients without obvious signs.

6. It can exclud the possibility of interference from other bacteria, the detection of pathogen antigens, and provide direct evidences.

7. Higher sensitivity than microscopy (the average sensitivity of the three pathogens was compared with the gold standard. The microscopy was about 53%. The taige triple inspection is about 90%).

8. It can avoid the demanding limitations of microscopic examination, such as trichomoniasis time, temperature, larvae, the sample 6 hours at room temperature or 72 hours at 2 ~ 8 ℃ may meet the requirement.

9. It can improve the detection rate of the sample when the patient has been infected but the traditional methods (microscopy, enzyme chemistry) can not detect.

10. It can avoid the subjective factors caused by the individual differences and the misjudgment caused by the operation factors.

11. Double antibody sandwich method was applied to improve the efficiency and specificity of catching the pathogen antigen.

12. It is easy to operate. (1) Operators do not need professional training. (2) All laboratory and inspection reports are completed within 16 minutes.

13. The product can be traced to the American ATCC standard strain.

1. The infection of candida vaginitis is mainly manifested by itching and burning of vulva, accompanied by urinary pain and painful intercourse and increased leucorrhea. The physical signs of candida vaginitis include vulva flush, edema, visible scratches or cracks. The inside of nympha and vaginal mucosa membrane may be attached by white membranoid substance. White rot-like secretions can be seen in the vagina, showing curd shaped.

2. Trichomonas vaginitis is mainly caused by the infection of trichomonas vaginalis.The typical symptom is an increase in leucorrhea, the leucorrhea can be a thin, white, yellow, or green bubble. Pruritus vulvae is a common symptom. If there are other bacterial infections, the leucorrhea will be purulent. The itching positions are mainly vaginal and vulva, sometimes with heat, pain, sexual pain, etc

3. The specific clinical manifestations of BV include: Thin, milk-like secretions may be evenly covered on the vaginal wall. The secretionsa smells fishy and the volume of the secretionsa may not be estimated. The stink increases during sexual intercourse. Some of the patients had mild vaginal and genital itching and burning; Nearly half of BV patients had no symptoms.

Clinical laboratory, gynaecology, gynecology screening, community health care.