Bacterial Vaginosis Rapid Diagnostic Test
Bacterial Vaginosis Rapid Diagnostic Test
China Disposable Bacterial Vaginosis Rapid Diagnostic Test (dry chemical enzymatic detection), is an in vitro diagnostic reagents products to test female bacterial vaginosis. Through testing the SNA, PH Value, LE, and H2O2, the four indicators of female vaginal discharge, evaluate comprehensively, and get the result, it has certain guiding significance for the clinical diagnosis.
The proliferation of Lactobacillus vaginalis and other pathogenic bacteria mainly from patients leads to a decrease in the concentration of hydrogen peroxide in the vagina and an increase in the pH; on the other hand, bacteria produce a large amount of sialidase, which is 100-1000 times higher than normal. When an inflammatory reaction occurs in the patient's vagina, the polynuclear leukocytes accumulate in the inflammatory lesion and release a large amount of leukocyte esterase.
Etiology and pathogenesis
Lactobacillus producing hydrogen peroxide is dominant in the normal vagina. At BV, Lactobacillus producing H2O2 in the vagina is reduced and other microorganisms are multiplied, mainly Gardnerella, anaerobic bacteria (C. mobilis, Prevobacter, Pseudomonas, Bacteroides, A. vaginalis) Etc.) and human mycoplasma, which are mostly anaerobic bacteria, the number of these microorganisms can be increased by 100 to 1000 times. As these microorganisms multiply, their metabolites cause a corresponding change in the biochemical composition of vaginal secretions, an increase in pH, amines (cadaverine, putrescine, trimethylamine), organic acids, and some enzymes (sialidase, Mucopolysaccharidase, etc.) increased. Amines can increase vaginal secretions and have an odor. Enzymes and organic acids can destroy the host's defense mechanisms, such as dissolving cervical mucus, promoting microbes into the upper genital tract and causing inflammation. However, the mechanism by which the microbiota changes is still unclear and may be related to multiple sexual partners, frequent sexual intercourse or vaginal lavage for vaginal alkalization. The alkaline environment is not conducive to the adhesion and growth of Lactobacillus, but is conducive to the growth of anaerobic bacteria such as Gardnerella, thereby causing BV.
Symptoms and signs
Most occur in women during sexual activity. 10% to 40% of patients have no clinical symptoms. Symptoms are mainly characterized by increased vaginal discharge, odor of fish gizzard, increased after sexual intercourse, and may be accompanied by mild genital itching or burning sensation. The secretions are grayish white, uniform, thin, and often adhere to the vaginal wall, but the viscosity is very low, it is easy to wipe the secretions from the vaginal wall, and the vaginal mucosa has no congestive inflammation.
1. Sensitivity: minimum detection level of neuraminidase should be 0.5 U/mL. Minimum detection level of leukocyte esterase should be 0.3 U/mL. Minimum detection level of Hydrogen peroxide should be 2µmol/L.
2. Consistency: when a same reference is used to test 10 cases, the color results shall besame.
3. Negative reference coincidence rate ≥ 90%
4. Positive reference coincidence rate ≥ 90%
5. Specificity: it won’t affect the result if hemoglobin concentration is lower than 50mg/dL.
Storage and Shelf Life
·Read the entire procedure carefully prior to testing.
·Do not open the foil pouch until get ready to perform the test
1)Take out the test device from its sealed foil pouch
2)Swab the pH test well 2-3 times with swab which collects secretion specimen. Observe the color change and record the pH value
3)Immerse the patients swab into extraction tube and add 12-14 drops of extraction solution in it. Squeeze the swab repeatedly to ensure thorough extraction.
4)Add each 2 drops of extracted specimen from extraction tube to the rest three wells ( H2O2, SA, LE , PH value well)
5)Add a drop of chromogenic regent to the H2O2 test well
6)Place the test device into Encode Incubator or attemperat at 42~45°C or thermostat water bath.
7)Read the result within 15 mins
Interpretation of results
Reference for the Multi-Test results
1. PH value indicates the PH value of secretion, positive indicates the PH of vagina is abnormal, vagina maybe infected
2. H2O2 indicates the quantity of lactobacillus in vagina, negative indicates large quantity of lactobacillus, positive indicates vaginal environment is sub-health
3. SA positive indicates BV infection
4. LE positive indicates vagina inflammations
1.Q: How does the Wholesale Women Bacterial Vaginosis Rapid Diagnostic Test involve?
A: China One Step Bacterial Vaginosis Rapid Diagnostic ComboTest Kit (dry enzymatic detection), is an in vitro diagnostic reagents products to test female bacterial vaginosis. Through testing the H2O2, PH value, SNa and LE, the four indicators of female vaginal discharge, evaluate comprehensively, and get the result, it has certain guiding significance for the clinical disgnosis.
2.Q: How can you ensure the quality of your products?
A: Samples will be prepared anytime, and we can send you our quality report before delivery.
3.Q: Does your factory do OEM?
A: Yes, we can produce the product according to our customers' required.
Payment & Package& Delivery
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