Bacterial vaginosis rapid detection kit (sialidase method) Instructions for use
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- Time of issue:2022-04-24
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(Summary description)Bacterial vaginosis rapid detection kit (sialidase method)
User Manual (V1.0)
【product name】
Generic name: rapid detection kit for bacterial vaginosis (sialidase method)
【Packaging Specifications】50 servings/box.
【Intended use】Suitable for rapid diagnosis of bacterial vaginosis.
【Test principle】This kit is made according to the principle that vaginal secretions of women with BV show abnormal sialidase activity. The action of sialidase can rapidly hydrolyze the substrate. After adding an appropriate chromogenic reagent, there will be obvious color changes, yellow is negative, blue or green is positive, and the darker the color, the higher the enzyme activity. The reagent operation is simple and fast, and the color changes of yin and yang are obvious. It can replace the Amsel method and be used by medical units at all levels for BV diagnosis and routine physical examination.
【Main components】
1. 50 BV testing bottles
2. BV color developing solution 9ml × 1 bottle
3. 1 copy of the instruction manual
The main components of BV detection bottle: sialidase specific substrate 0.2g/L, potassium acetate 50g/L
The main component of BV color developing solution: sodium hydroxide 40g/L.
【Storage conditions and validity period】 Store at 4℃~26℃, the validity period is 12 months.
【Sample requirements】
Specimen collection: After inserting the speculum, use a cotton swab to take secretions from the vaginal sidewall or posterior fornix, collect as much as possible, and send them for inspection immediately.
【Testing method】
1. Take 1 BV test bottle for use, and open the bottle cap of the test bottle.
2. Immerse the sampling swab in the solution of the test bottle, stir and mix gently, fully squeeze the liquid on the wall of the test bottle with the cotton swab, discard the cotton swab, and place the test bottle in a warm bath at 37°C for 10 minutes.
3. Take BV chromogenic solution, remove the cap, add 1-2 drops of BV chromogenic solution to the BV detection bottle, shake and mix well.
4. Observe the results immediately within three minutes after adding the developer.
【Explanation of test results】
Positive result: The liquid in the BV test bottle is blue or green, indicating positive.
Negative result: The liquid in the BV test bottle is yellow, indicating negative.
【Limitations of the test method】
1. The test results largely depend on the collection of specimens. Improper specimen collection or operation will affect the accuracy of the test results.
2. Positive results provide diagnostic information for the appearance of BV, and clinical diagnosis needs to be combined with clinical symptoms.
【Product performance index】
1. The detection accuracy of the kit for sialidase-containing quality control samples is 100%, and the detection repeatability for sialidase-containing quality control samples is 100%.
2. There should be no difference in the intra-batch imprecision of the sialidase-containing quality control samples, and no difference in the inter-batch imprecision.
【Precautions】
1. Threatened abortion and menstrual period women are prohibited.
2. Before sampling, the patient shall not use vaginal cream or perform vaginal lavage within 24 hours.
3. Collect specimens correctly, and do not collect vaginal secretions from the cervix. Specimens should be submitted for inspection in time, and the sensitivity will be reduced if left for too long. Standardized operating procedures are the key to accurate detection.
4. This product is only used for in vitro diagnosis and is for one-time use. It should not be used if the liquid in the detection bottle is leaking, turbid, or precipitated.
5. Read the instruction manual carefully before use and use it within the validity period.
6. Discarded specimens and test materials after use should be sterilized and discarded.
【Explanation of the logo】
：In vitro diagnostic medical devices.
：Refer to the instructions for use.
：Not to be used twice
【references】
1. Linda Myziuk,1* Barbara Romanowski,1 and Stephen C. Johnson2. 2003 BVBlue Test for Diagnosis of Bacterial Vaginosis.J.clinical microbial.41:1295-1298.
2. Wiggins, R., T. Crowley, P. J. Horner, P. W. Soothill, M. R. Millar, and A. P.Corfield. 2000. Use of 5-bromo-4-chloro-3-indolyl-_-D-N-acetylneuraminic acid in a novel spot test to identify sialidase activity in vaginal swabs fromwomen with bacterial vaginosis. J. Clin. Microbiol. 38:3096–3097.
3. Howe, L., R. Wiggins, P. W. Soothill, P. J. Horner, M. R. Millar, and A. P.Corfield. 1999. Mucinase and sialidase activity of the vaginal microflora:implications for the pathogenesis of preterm labour. Int. J. STD AIDS10:442–447.
4. Thomason,.J.A.;et al..Premature rupture of membranes and bacterial vaginosis.Am.J.Obstet.Gynecol. 1993; 169:463.
5. Cauci, S., S. Driussi, R. Monte, P. Lanzafame, E. Pitzus, and F. Quadrifoglio.1998. Immunoglobulin A response against Gardnerella vaginalis hemolysinand sialidase activity in bacterial vaginosis. Am. J.
Bacterial vaginosis rapid detection kit (sialidase method) Instructions for use
(Summary description)Bacterial vaginosis rapid detection kit (sialidase method)
User Manual (V1.0)
【product name】
Generic name: rapid detection kit for bacterial vaginosis (sialidase method)
【Packaging Specifications】50 servings/box.
【Intended use】Suitable for rapid diagnosis of bacterial vaginosis.
【Test principle】This kit is made according to the principle that vaginal secretions of women with BV show abnormal sialidase activity. The action of sialidase can rapidly hydrolyze the substrate. After adding an appropriate chromogenic reagent, there will be obvious color changes, yellow is negative, blue or green is positive, and the darker the color, the higher the enzyme activity. The reagent operation is simple and fast, and the color changes of yin and yang are obvious. It can replace the Amsel method and be used by medical units at all levels for BV diagnosis and routine physical examination.
【Main components】
1. 50 BV testing bottles
2. BV color developing solution 9ml × 1 bottle
3. 1 copy of the instruction manual
The main components of BV detection bottle: sialidase specific substrate 0.2g/L, potassium acetate 50g/L
The main component of BV color developing solution: sodium hydroxide 40g/L.
【Storage conditions and validity period】 Store at 4℃~26℃, the validity period is 12 months.
【Sample requirements】
Specimen collection: After inserting the speculum, use a cotton swab to take secretions from the vaginal sidewall or posterior fornix, collect as much as possible, and send them for inspection immediately.
【Testing method】
1. Take 1 BV test bottle for use, and open the bottle cap of the test bottle.
2. Immerse the sampling swab in the solution of the test bottle, stir and mix gently, fully squeeze the liquid on the wall of the test bottle with the cotton swab, discard the cotton swab, and place the test bottle in a warm bath at 37°C for 10 minutes.
3. Take BV chromogenic solution, remove the cap, add 1-2 drops of BV chromogenic solution to the BV detection bottle, shake and mix well.
4. Observe the results immediately within three minutes after adding the developer.
【Explanation of test results】
Positive result: The liquid in the BV test bottle is blue or green, indicating positive.
Negative result: The liquid in the BV test bottle is yellow, indicating negative.
【Limitations of the test method】
1. The test results largely depend on the collection of specimens. Improper specimen collection or operation will affect the accuracy of the test results.
2. Positive results provide diagnostic information for the appearance of BV, and clinical diagnosis needs to be combined with clinical symptoms.
【Product performance index】
1. The detection accuracy of the kit for sialidase-containing quality control samples is 100%, and the detection repeatability for sialidase-containing quality control samples is 100%.
2. There should be no difference in the intra-batch imprecision of the sialidase-containing quality control samples, and no difference in the inter-batch imprecision.
【Precautions】
1. Threatened abortion and menstrual period women are prohibited.
2. Before sampling, the patient shall not use vaginal cream or perform vaginal lavage within 24 hours.
3. Collect specimens correctly, and do not collect vaginal secretions from the cervix. Specimens should be submitted for inspection in time, and the sensitivity will be reduced if left for too long. Standardized operating procedures are the key to accurate detection.
4. This product is only used for in vitro diagnosis and is for one-time use. It should not be used if the liquid in the detection bottle is leaking, turbid, or precipitated.
5. Read the instruction manual carefully before use and use it within the validity period.
6. Discarded specimens and test materials after use should be sterilized and discarded.
【Explanation of the logo】
：In vitro diagnostic medical devices.
：Refer to the instructions for use.
：Not to be used twice
【references】
1. Linda Myziuk,1* Barbara Romanowski,1 and Stephen C. Johnson2. 2003 BVBlue Test for Diagnosis of Bacterial Vaginosis.J.clinical microbial.41:1295-1298.
2. Wiggins, R., T. Crowley, P. J. Horner, P. W. Soothill, M. R. Millar, and A. P.Corfield. 2000. Use of 5-bromo-4-chloro-3-indolyl-_-D-N-acetylneuraminic acid in a novel spot test to identify sialidase activity in vaginal swabs fromwomen with bacterial vaginosis. J. Clin. Microbiol. 38:3096–3097.
3. Howe, L., R. Wiggins, P. W. Soothill, P. J. Horner, M. R. Millar, and A. P.Corfield. 1999. Mucinase and sialidase activity of the vaginal microflora:implications for the pathogenesis of preterm labour. Int. J. STD AIDS10:442–447.
4. Thomason,.J.A.;et al..Premature rupture of membranes and bacterial vaginosis.Am.J.Obstet.Gynecol. 1993; 169:463.
5. Cauci, S., S. Driussi, R. Monte, P. Lanzafame, E. Pitzus, and F. Quadrifoglio.1998. Immunoglobulin A response against Gardnerella vaginalis hemolysinand sialidase activity in bacterial vaginosis. Am. J.
- Categories:Product Description
- Author:
- Origin:
- Time of issue:2022-04-24
- Views:0
Bacterial vaginosis rapid detection kit (sialidase method)
User Manual (V1.0)
【product name】
Generic name: rapid detection kit for bacterial vaginosis (sialidase method)
【Packaging Specifications】50 servings/box.
【Intended use】Suitable for rapid diagnosis of bacterial vaginosis.
【Test principle】This kit is made according to the principle that vaginal secretions of women with BV show abnormal sialidase activity. The action of sialidase can rapidly hydrolyze the substrate. After adding an appropriate chromogenic reagent, there will be obvious color changes, yellow is negative, blue or green is positive, and the darker the color, the higher the enzyme activity. The reagent operation is simple and fast, and the color changes of yin and yang are obvious. It can replace the Amsel method and be used by medical units at all levels for BV diagnosis and routine physical examination.
【Main components】
1. 50 BV testing bottles
2. BV color developing solution 9ml × 1 bottle
3. 1 copy of the instruction manual
The main components of BV detection bottle: sialidase specific substrate 0.2g/L, potassium acetate 50g/L
The main component of BV color developing solution: sodium hydroxide 40g/L.
【Storage conditions and validity period】 Store at 4℃~26℃, the validity period is 12 months.
【Sample requirements】
Specimen collection: After inserting the speculum, use a cotton swab to take secretions from the vaginal sidewall or posterior fornix, collect as much as possible, and send them for inspection immediately.
【Testing method】
1. Take 1 BV test bottle for use, and open the bottle cap of the test bottle.
2. Immerse the sampling swab in the solution of the test bottle, stir and mix gently, fully squeeze the liquid on the wall of the test bottle with the cotton swab, discard the cotton swab, and place the test bottle in a warm bath at 37°C for 10 minutes.
3. Take BV chromogenic solution, remove the cap, add 1-2 drops of BV chromogenic solution to the BV detection bottle, shake and mix well.
4. Observe the results immediately within three minutes after adding the developer.
【Explanation of test results】
Positive result: The liquid in the BV test bottle is blue or green, indicating positive.
Negative result: The liquid in the BV test bottle is yellow, indicating negative.
【Limitations of the test method】
1. The test results largely depend on the collection of specimens. Improper specimen collection or operation will affect the accuracy of the test results.
2. Positive results provide diagnostic information for the appearance of BV, and clinical diagnosis needs to be combined with clinical symptoms.
【Product performance index】
1. The detection accuracy of the kit for sialidase-containing quality control samples is 100%, and the detection repeatability for sialidase-containing quality control samples is 100%.
2. There should be no difference in the intra-batch imprecision of the sialidase-containing quality control samples, and no difference in the inter-batch imprecision.
【Precautions】
1. Threatened abortion and menstrual period women are prohibited.
2. Before sampling, the patient shall not use vaginal cream or perform vaginal lavage within 24 hours.
3. Collect specimens correctly, and do not collect vaginal secretions from the cervix. Specimens should be submitted for inspection in time, and the sensitivity will be reduced if left for too long. Standardized operating procedures are the key to accurate detection.
4. This product is only used for in vitro diagnosis and is for one-time use. It should not be used if the liquid in the detection bottle is leaking, turbid, or precipitated.
5. Read the instruction manual carefully before use and use it within the validity period.
6. Discarded specimens and test materials after use should be sterilized and discarded.
【Explanation of the logo】
：In vitro diagnostic medical devices.
：Refer to the instructions for use.
：Not to be used twice
【references】
1. Linda Myziuk,1* Barbara Romanowski,1 and Stephen C. Johnson2. 2003 BVBlue Test for Diagnosis of Bacterial Vaginosis.J.clinical microbial.41:1295-1298.
2. Wiggins, R., T. Crowley, P. J. Horner, P. W. Soothill, M. R. Millar, and A. P.Corfield. 2000. Use of 5-bromo-4-chloro-3-indolyl-_-D-N-acetylneuraminic acid in a novel spot test to identify sialidase activity in vaginal swabs fromwomen with bacterial vaginosis. J. Clin. Microbiol. 38:3096–3097.
3. Howe, L., R. Wiggins, P. W. Soothill, P. J. Horner, M. R. Millar, and A. P.Corfield. 1999. Mucinase and sialidase activity of the vaginal microflora:implications for the pathogenesis of preterm labour. Int. J. STD AIDS10:442–447.
4. Thomason,.J.A.;et al..Premature rupture of membranes and bacterial vaginosis.Am.J.Obstet.Gynecol. 1993; 169:463.
5. Cauci, S., S. Driussi, R. Monte, P. Lanzafame, E. Pitzus, and F. Quadrifoglio.1998. Immunoglobulin A response against Gardnerella vaginalis hemolysinand sialidase activity in bacterial vaginosis. Am. J. Obstet.Gynecol.178:511–515.
6. Yuan Jiangying, Li Qinfang Determination of vaginal fluid sialidase activity to diagnose bacterial vaginosis. Journal of Practical Obstetrics and Gynecology 2001.17:75.
7. Ye Huiming, Shi Wensheng, Bai Haiyan. The application of sialidase assay in the diagnosis of bacterial vaginosis. Advances in Modern Obstetrics and Gynecology 2007.16:392-393.
8. Wu Runxiang, Zhu Xinjian, He Ying, etc. Clinical application value of BV blue rapid detection method for bacterial vaginosis. Journal of Modern Laboratory Medicine. 2006.21:12-14.
9. Ma Yunan. Bacterial vaginosis and its diagnosis. Chinese Journal of Laboratory Medicine, 2000, 23(5): 303-304.
10. Li Yun, Jiao Chunmei, Han Yuhua, etc. Discussion on the value of sialidase assay in the diagnosis of bacterial vaginosis. Huaxia Medicine, 2002, 15(6): 730-732.
【Basic Information】
Name of the registrant/manufacturer: Zhuhai Meihua Medical Technology Co., Ltd.
Address: Unit 3B-3, 3rd Floor, Annex Building, Building 10, Science and Technology 1st Road, Gangwan Avenue, Tangjiawan Town, Zhuhai City
Contact: (0756) 3865699
Postcode: 519085
Tel: (0756) 3865688 Fax: (0756) 3865669
http://www.meihuayl.com
Name of after-sales service unit: Zhuhai Meihua Medical Technology Co., Ltd.
Contact: 400-603-1358
Production address: Unit 3B-3, 3rd Floor, Annex Building, Building 10, Science and Technology 1st Road, Gangwan Avenue, Tangjiawan Town, Zhuhai City
Production license number: Guangdong Food and Drug Administration Production Xu No. 20081652
【Medical device registration certificate number/product technical number】
Medical device registration certificate number:
Product technical requirement number:
【Approval date and revision date of the manual】 June 1, 2015
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400-603-1358
E-mail：market@meihuayl.com
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© 2022 Zhuhai Meihua Medical Technology Co., Ltd. All rights reserved. 粤ICP备2022023050号 SEO