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

Transport Package
OEM or Carton
Specification
OEM
Trademark
Quickclean or customized brand
Origin
China
Production Capacity
10000 PCS/Day
Reference Price
Please contact us for quote
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Product Description

Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals
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 H 2 O 2 , 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
Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals
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
Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals
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
Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals Clinical result judgement list
Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals Announcements
Singclean Wholesale CE Approved One Step Rapid Urine Dry Chemical Enzymatic Reaction Std Bacterial Vaginosis Test Kit for Female Genitals
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. 


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

 

IVD

PNEUTEC.IT, 2023