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Bacterial Vaginosis Multi-Test Kit (Enzymatic Reaction)

Bacterial Vaginosis Combo Test Kit is for rapid screening, diagnosis and treatment evaluation of Bacterial vaginosis. This kit is a qualitative diagnosis of BV basis on H2O2 determination, sialidase activity test(SA), leukocyte esterase activity test(LE), candida vaginitis(CV), trichomonas vaginitis(TV) and pH value measurement. This kit is intended for use as an aid in the diagnosis of bacterial vaginosis.


KIT COMPONENTS
COMPONENTS
DETAIL
QUANTITY
Individual packed BV test  cassette
Each device contains with treated membrane
20pcs
Extraction solution
For specimen extraction
12ml*1 bottle
Chromogenic reagent
For chromogenic reaction
2ml*1 bottle
Extraction tube
For specimens preparation use
20pcs
Sterile Pipette
For operating
20pcs
Package Insert
For operation instruction
1pc

PROCEDURE

·     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 ,CV,TV 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
NOTE:

·     The result will be invalid when reading after 30min


PRINCIPLE

The kit is scientific to prepare on the basis of multi-test of, H2O2,sialidase (SA) and leuk-esterase (LE), candida vaginitis(CV), trichomonas vaginitis(TV) and pH value. These specific substrates will reacted with chromogenic reagent in the condition of enzyme.
(1).H2O2
H2O2reacts with peroxidase to produce nascent oxygen. With existence of 4-Aminoantipyrine, the nascent oxygen oxidizes 2,4,6-Trihydroxybenzoic acid to turn red. The intensity of red color is in proportion to H2O2concentration.
 
(2). Sialidase (SA)
The substrate BCIN (5-Bromo-4-chloro-3-indolyl -α-D-N-acetylneuraminic acid sodium), while reacting with neuramidinase (sialidase), will be decomposed into indoles, which will be oxidized to turn blue. The intensity of blue color is in proportion to sialidase activity level.
 
(3). Leukocyte esterase (LE)
The substrate BCIA (5-Bromo-4-chloro-3-indolyl -α-D-N-acetyl acetate), while reacting with leukocyte esterase; will be decomposed into indoles, which will be oxidized to show blue. The intensity of blue color is in proportion to leukocyte esterase activity level.
 
(4). Candida vaginitis(CV)
Candida has a strong NAG activity. The substrate reacts with it, will be decomposed into Nitrate phenylacetyl amino glucoside, release nitrophenol which will turn to yellow. The intensity of yellow color is in proportion to NAG activity level.
 
(5) Trichomonas vaginitis(TV)
The substrate will react with specific proteolytic enzyme in trichomonas. Which will hydrolysis in a short time and appear light blue or blue is positive result, if no color change is negative result. The intensity of blue color is in proportion to quantity of trichomonas.
 
6).PH value
pH value test is based on the principle of acid - base indicators. Yellow, greenish yellow or green color indicate pH value ≤4.5, whereas greenish blue or blue indicate pH value >4.5


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