In Vitro Diagnostic Reagents Products
Bacterial Vaginosis Combo Test Kit CE Approved

Bacterial Vaginosis Quick Test Kit (Sialidase Detection)
Instruction for Use


[Product name]
Bacterial Vaginosis Quick Test Kit (Sialidase Detection)


[Packing size]
20 pcs/kit; 50 pcs/kit


[Intended use]
For qualitatively testing activity of neuraminidase in female’s vaginal fluid, only for auxiliary diagnosis of bacterial vaginosis.


[Testing principle]
Neuraminidase is one of pathogenic factors of bacterial vaginosis (BV). Activity of neuraminidase in vaginal fluid of BV women is significantly higher than that in vaginal fluid of normal women; there is no or only a small amount of neuraminidase in vaginal fluid of normal women. By testing for neuraminidase higher than normal level in the vaginal fluid, patients can be diagnosed whether have BV.
This kit mainly contains bacterial neuraminidase-specific chromogenic substrate solution. When the reagent contacts neuraminidase in the sample, the substrate is hydrolyzed to produce sialic acid and chromophoric groups, chromophoric groups are further changed to blue by oxygen in air, and test results are read immediately after specified reaction time. Bacterial vaginosis is positive if the solution or swab head becomes blue, and bacterial
vaginosis is negative if the solution or swab head does not change color.


[Main components]


No. Component Name Quantity
1 BV reaction tube
Neuraminidase-specific chromogenic substrate
20 servings/kit; 50 servings/kit
300μl/servings; 300μl/servings
2 Instructions for use (IFU) 1 pcs 1 pcs


[Storage conditions and validity]
Have a validity of 12 months when stored in 2- 8 in non-corrosive gas in dry placesprotected from light.


[Applicable instruments]
Water-proof incubators or water-bath heaters that can be controlled to 35-37


[Sample requirements]
1. Rotate for 10-20 s at posterior fornix of vagina to collect as much vaginal fluid of the patient as possible until fluid can be clearly seen on the swabs.
2. Samples shall be collected during non-menstrual period, sexual intercourse, tub bath, vaginal douche and local drug use shall not be allowed during 24 hours before sample 
collection, and samples shall not be collected from patients using female hormone or during pregnancy. Samples collected during menstrual period will affect result interpretation and shall not be subjected to this testing, and patients using female hormone will affect results and shall not be subjected to this testing.

3. The sampled specimens shall be timely tested, otherwise they shall be stored at 2~8and tested the same day.
4. Congestive samples will affect result interpretation and shall not be subjected to this testing.


[Testing method]
1. Take out quantity of BV reaction tubes as required and balance them to room temperature.
2. Immerse the swabs in solution of the BV reaction tubes and stir and mix them evenly, and leave swabs in the test tubes. Place the reaction tubes with swabs at 37
to incubate them.
3. Take the reaction tubes out after 10 minutes and observe color change of solution and swab heads directly, and it can be interpreted as being positive when the solution in the BV reaction tube or the swab head is blue; it can be interpreted as being negative if both the solution in the BV reaction tube and the swab head have no color change.
Note: The results are invalid if they are interpreted after 20 minutes.


[Reference range]
By testing 120 clinical samples and verifying by using Chi-square testing, reference range of this product is: Negative when neuraminidase<7 U/mL. 


[Interpretation of testing results]
1. When there is significant difference between testing results and microscopic examination results, it is recommended to take new reagents to test again.
2. Samples collected during menstrual period and pregnancy will affect test results, so use of such samples shall be avoided.


[Limitations of testing method]
1. This kit is a qualitative testing product.
2. Interpretation of chromogenic results has somewhat subjectivity.
3. Test items of this kit are only for preliminary screening and auxiliary diagnosis of bacterial vaginosis.
4. Improper sample collection and/or experimental operation may affect testing results.


[Performance indicators of the product]
1. Sensitivity ≥0.5 U/mL
2. Uniformity: When using the same reference to test 10 servings, the results showed are uniform
3. Agreement rate of negative reference ≥90%
4. Agreement rate of positive reference ≥90%

5. Specificity

Hemoglobin with a concentration of less than 250 mg/dL has no influence on results;

Vitamin C with a concentration of less than 500 mg/dL has no influence on results;
Escherichia coli CMCC (B) 44102, staphylococcus aureus CMCC (B) 26003, candida albicans
CMCC (F), and 98001Neuraminidase testing shows negative results.

[Precautions]
1. This product is only for in vitro auxiliary diagnosis, and testing results shall be determined comprehensively by combining other confirmed methods and clinical symptoms.
2. Be aware of expiry date of this productand use it within the validity.
3. This product is not applicable to women who use vaginal drugs such as vaginal suppository, cream, emulsion, spermicide within 72 hours before sample collection.
4. 37
water-proof incubators or water-bath heaters can be used for incubation. To avoid liquid evaporation or vapor entryduring incubation, try to close lid of the tube.



Specifications
50 tests/kit
Applicable scope

For qualitative determining hydrogen peroxide (H2O2) concentration, pH value, neuraminidase (SNa) and leukocyte esterase (LE)activity in female vaginal secretion; only serving as assistant in diagnosis of bacterial vaginosis.