Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals

• Type: IVD Reagent
• Neuraminidase-Specific Chromogenic Subst: 300μl/Servings; 300μl/Servings
• BV Reaction Tube: 20 Servings/Kit; 50 Servings/Kit
• Packing Size: 20 PCS/Kit; 50 PCS/Kit
• Storage Conditions and Validity: Validity of 12 Months When Stored in 2ºC - 8
• Applicable Instruments: Water-Proof Incubators or Water-Bath Heaters That
• Transport Package: OEM or Carton
• Specification: OEM
• Trademark: Quickclean or customized brand
• Origin: China
• Production Capacity: 10000 PCS/Day

Product Description

Product introduction
Bacterial vaginosis diagnostic strip sets(dry chemical 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 diagnosis.

Product Principle

Product application
Used to assist in the diagnosis of bacterial vaginosis, evaluate the microecological balance in the genital tract, and so to prevent the repeated disease of vaginosis.

Test Procedure

Main Component
 

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

Result Judgement
Clinical judgment standard
Clinical result judgement list
Announcements

Storage and Shelf Life
Store below 2ºC~ 8ºC. It expires after 12 months., The product must be used within 8 hours after the aluminum foil bag for the reaction strip is unpacked.
Cautions
1. Rotate the cotton swab at the vaginal for nix for 10-20 sec. Try to collect more vaginal discharge from the patient until the discharge is clearly visible on the cotton swab, and assay the specimen after collection.
2. Don't acquire specimens during the menstrual period. Don't acquire a specimen if the patient had sex, bath, vaginal irrigation, or applied local medication within 24 hours.
3. Keep it below 2°C ~8°ºC for assay latter in the day.
4. This product only can be used as an assistant for in vitro diagnosis. Test results should be combined with other validated equivalent methods and clinical symptoms before comprehensive diagnosis.
5. Components from different batches of the reagent kits shall not be cross-used.
6. Please read the instructions for use carefully. Compare to the standard colorimetric card to determine the color result.

Testing Method
1. Take out the quantity of BV reaction tubes as required and balance them to room temperature.
2. Immerse the swabs in a solution of the BV reaction tubes stir and mix them evenly, and leave swabs in the test tubes. Place the reaction tubes with swabs at 37ºC to incubate them.
3. Take the reaction tubes out after 10 minutes and observe the color change of the solution and swab heads directly, 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, the reference range of this product is: Negative when neuraminidase<7 U/mL.