Purpose

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.

 

Working 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

H2O2 reacts 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 H2O2 concentration.

 

(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

 

Contents of the kit

(1) BV test card 20pcs

(2) BV extracting Liquid 12ml×1 btl

(3) Chromogenic reagent 2ml×1 btl

(4) Sterile Pipette 20pcs

(5) Extraction tube 20pcs

(6) Instruction 1pcs

 

Operation procedures

 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

 

Observation of results

(1) PH well:Yellow, greenish yellow or green color indicates normal result; the presence of greenish blue or blue indicates abnormal result.

(2) H2O2 well: Red indicates normal result; no color change indicates abnormal result

(3) SA well: Light blue or blue indicates positive result; no color change indicates negative result.

(4) LE well: Greenish blue or blue indicates positive result; no color change indicates negative result.

(5) CV well: Light yellow, yellow or greenish yellow color indicates positive result; no color change indicates negative result

(5) TV well: Light blue, blue color indicates positive result; no color change indicates negative result

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
5. CV positive indicates fungus infection
6. TV positive indicates trichomonas infection