Bacterial Vaginosis rapid test, biochemistry reagent, medical reagents

Bacterial Vaginosis rapid test 1.Ce, ISO approved 2. A One Step Assay for the Detection of Bacterial Vaginosis

Bacterial Vaginosis rapid test

Bacterial Vaginosis (BV) multi-measurement set includes three indicators  H2O2 ( biomarker of vaginal lactobacillus), SNA (sialidase, lyoenzyme of pathogenic bacterium of BV such as Gardnerella Vaginalis,Mobiluncus Spp, etc.), LE (Leukocyte Esterase, biomarker of vaginal inflammation cell).

[Principle]

1. H2O2 Concentration Test

H2O2 in vaginal liquid broke into O2 and H2O by peroxidase, then O2 reacts with 4-AA which makes 3, 5-dichloro dihydroxy benzenesulfonic acid change color. When H2O2 concentration is more than 2μmol/l in sample, the color becomes red or purple, or the color is still blue.

2. SNA Activity Test

5-bromo-4chloro-3indolyl neuraminide broke into bromo indolyl and neuraminide by SNA, and indolyl react with diazonium which develops red or purple. The degree of color is positively related to SNA activity.

3. LE Test

5-bromo-4chloro-3indolyl acetate releases bromo indolyl by LE, and bromo indolyl reacts with O2 which develops blue or green. The degree of color is positively related to LE activity.

[Procedure]

1. Remove the aluminum foil case and take out of the reaction cassette, tear up the aluminum foil strip, then protect the cassette from the light.

2. Collect the secretion from vaginal fonix with a cotton swab and add 400μl dilute liquid to the tube, and press the cotton swab repeatedly and separates the vaginal secretion.

3. Add a drop of the sample (about 35ul) to the three holes in cassette respectively, then add a drop of color developing solution into SNA reactive hole.

4. Place the reactive cassette in 37 for 15 minutes, or room temperature for 30 minutes. Read the degree of developing color, get the result

 1). H2O2 (the upper hole of cassette)

Normal over 2umol/l, red or purple

Abnormal  less than 2umol/l, blue

2). SNA (the middle hole of cassette)

Normal  clear color

Abnormal  red or purple

Caution

1. This set is only for in vitro diagnostic use.

2. Read the manual carefully and train the users.

3. Make sure the name of testing holes in cassette .

Upper  H2O2       

Middle  SNA         

Below  LE

4. Remove the aluminum foil strip carefully and prevent the reactive films falling from the holes of cassette

5. Test the samples immediately, or place the sample at 4. The samples should be tested in one day.

6. This set can’t be reused, and use before the expiry date. Handle the waste properly.

7. The color developing solution can only be used in the reactive hole of SNA.

8. The sample is accepted if the SNA reaction hole develops brown yellow.

[Performance date]

    1. Repeatability

      1) Within-run over 90%

      2) Inter-run over 90%

2. Sensitivity

H2O2 over 2 μmol/L

SNA over 7 U/ml

LE over 9U/ml

3. Relevance with positive reference material: over 90%

4. Relevance with negative reference material: over 90%

[Expiration date]

One year.

[Package size]

20 tests / kit

[Kit compositions]

1. Product manual    1 share

2. Reaction cassette   20 sets

3. Dilute liquid       1 vial (PH 6.5, 10mmol MES NaCl 0.9%)

4. Color developing solution    1 vial

[Using conditions]

Kits should be used at 15-30, protecting from light.

[Storage conditions]

Stored at 2-8, protecting from light.

Biosino Bio-Technology and Science Inc.

Add No.27, Chaoqian Road, Changping District,

102200 Beijing, China

Tel +86-10-69722840, Fax +86-10-69722840

Bacterial Vaginosis rapid test, biochemistry reagent, medical reagents