1. Purpose
The kit is for rapid diagnosis and treatment evaluation of Bacterial vaginosis.

2.  Outline
Bacterialvaginosis is actually a symptom-comlex caused by the decrease of common bacterial population and the increase of anaerobic bacteria, e.g., Bacteroides, Mobiluncus spp, Gardnerella vaginalis, Prevotella spp, Peptococeus, and Mycoplasma hominis, etc. With a high morbidity (10-15%), Bacterial vaginosis is often attributed to habitual abortion, premature labor, premature breaking of fetal membrane, intrauteral infection, pelvic inflammation, cervical ulcer, andsome other complicateddiseases. The polybacterial infection yields great difficulty to bacteriological diagnosis. The standard BV laboratory diagnostic method "Amsel" , so called gold standard, which is well recognized, covers the following items : (1). PH>4.5 invagina (2).Increased diluted vaginal secretion with peculiar smell (3). Positive amine test (4). The clue cell can be found in vaginal secretion smear. The card is characterized by accuracy, simplicity, rapidity and  sensitivity. The correlation rate with Amsel reaches  92%, providing a  satisfactory diagnostic result.

3.  Principle
The kit is scientifically prepared on the basis of sialidase test which specifically respondes in Bacterial vaginosis. Sialidase, the special proteolytic enzyme which exists in secretion of bacterial vaginitis is extracted with extracting fluid. After the extraction sialidase will progressively hydrolyse the protein which exists on the swab made specially. Positive sample will turn to blue and negative result exists no change after 15 to 20 minutes. The operation of the test kit is very simple. The whole test can be done with only one steps and needs no special apparatus.What the kit assays is the related enzymes leading to Bacterial vaginosis.

 
4. Contents of the kit
 (1) BV sweb     20/40pcs
(2) BV extracting liquid   3ml×1 btl
(3) Instruction                 1pcs

5.  Attentions
(1) Please read the instruction carefully before operation.
(2) Please deal with waste according to hospitals or the environmental protection departments
because of some potential risk.
(3) The extracting liquid is uneffective when it turns to blue.
(4) For in vitro use only.

6.  Sample collection
Insert vaginal forceps and collect sample with a special BV swab from the vaginal wall. Collecting sample as much as possible and send it to test immediately.

7. Equipment required
    35~37°C attemperator

8. Instructions for use
(1) open the tube with swab, add 3 drops of extracting liquid to the cotton head and close the tube
(2) keep the tube in 35~37°C attemperator for 15~20min
   Attention: a. Please assure that the cotton head is wetted by the extracting liquid but not excess;
            b.The result will be uneffective when reading after 30min

9. Observation of result
   The test is positive when the swab turns to blue and negative has no colour alteration.

10. Detection limit
The detection limit of the kit is 7 units per ml.

11. Storage and validity duration
    Sealand keep the extracting liquid at 2~8°C, others keep at room temperature without corrosive gases.

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.