Bacterial Vaginosis Rapid Test Kit core Chromogenic Ingredient IBX-4041 CAS NO.1629579-82-3

BVBLUE Test Kit Component

1)BVBLUE Developer Solution: Water and Sodium hydroxide

2) BVBLUE Testing Vessel: Water, Potassium acetate, IBX-4041 (chromogenic substrate compound).

IBX-4041 is the key ingredient of BVBLUE test kit, BVBLUE test is a rapid sialidase test for bacterial vaginosis. BVBLUE test method is currently the only test method approved by the FDA for testing Bacterial Vaginosis(BV), The BV BLUE Test contains a chromogenic substrate of sialidase enzyme, IBX-4041.

BV Blue test is a commercially available test, it detects sialidase activity, an enzyme produced by BV-associated bacteria such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. In the test procedure, a vaginal fluid sample is placed in the test vessel which contains a chromogenic substrate for sialidase. After incubation, a developer solution is added, and If the sample contained a high level of sialidase, a blue or green color is seen. Samples containing no sialidase, or low levels of this enzyme, will generate a yellow color in the reaction. The BV test has high specificity and sensitivity.  The BVBlue™ test enables rapid detection of BV in a physician's office, and can thereby provide advantages over the Amsel methods and other methods requiring extensive laboratory testing.

Advantage of BVBLUE Test Kit

Compared to other diagnostic test methods for BV such as Amsel criteria, Nugent Gram-stain scoring system, Affirm® Microbial Identification Test, BVBLUE Test Kit has following advantage:

1, BVBLUE Test is currently the only test method approved by the FDA for testing Bacterial Vaginosis(BV).

2, BVBLUE Test just take 10 minutes to 15 minutes to get the result.

3, High purity sialidase substrate with high specificity can reduce the occurrence of false positive.

4. Comparing with the gold standard, the coincidence rate is high, the relative sensitivity is 93%, and the specificity is 95%.

5. Easy to operate, do not need equipment.

6. The specimen does not need to pretreat.

Currently available BV diagnostic methods suffer from various disadvantages:

1, The Amsel criteria requires the presence of three out of four criteria elements: (1) thin, homogeneous, milky vaginal discharge; (2) vaginal-fluid pH greater than 4.5; (3) a positive whiff test (i.e., production of a fishy odor when 10% KOH is added to a slide containing vaginal fluid); and (4) clue cells (greater than 20% of epithelial cells with adherent bacteria) .  It relies heavily on the proficiency of the individual clinician and/or laboratory, and are effectively impossible to standardize.

 2, The Nugent Gram-stain score utilizes Gram's staining of vaginal fluid to distinguish normal vaginal flora (i.e. gram-positive rods and lactobacilli) from bacterial vaginosis flora (gram-negative morphotypes). It relies heavily on the proficiency of the individual clinician and/or laboratory, and are effectively impossible to standardize.

3, The Affirm test relies on direct detection of bacterial DNA and improved accessibility, but allows for only qualitative detection of a single organism (G. vaginalis), and thus lacks diagnostic accuracy.

4, Pip Activity TestCard, a prolineaminopeptidase test card, although a card test is available for the detection of elevated pH and trimethylamine, it has low sensitivity and specificity and therefore is not recommended.

5, Culture of Gardnerella vaginalis is not recommended as a diagnostic tool because it is not specific.

6, Cervical Pap tests have no clinical utility for the diagnosis of BV because of their low sensitivity.

Core Chromogenic Ingredient IBX-4041 for Bacterial Vaginosis BV Blue Rapid Test Kit

Bacterial Vaginosis Rapid Test Kit core Chromogenic Ingredient IBX-4041

IBX-4041 Testing vessel

BV Blue active ingredient

BVBlue active ingredient

BVBlue substrates

BV Blue substrates

BVBlue® substrates

BVBlue™ substrates

Chromogenic substrate IBX-4041

chromogenic substrate of sialidase enzyme

Detection reagent for bacterial vaginosis (sialidase two-step method)

Shenzhen BST Science & Technology Co., Ltd sells and exports chromogenic substrate of sialidase enzyme IBX-4041.

Specification:

Appearance: Light yellow solid powder

Purity: 95% min

Application: Two-step chromogenic substrates of neuraminidase (sialidase)

Storage:  2-8℃, keep Away from Moisture and light

Packaging details: 1g per bottle or according to customer’s requirement