OSOM® BVBLUE® Bacterial Vaginosis Test (25 Tests/Kit)
$250.00
Professional Use Only
10-Minute Results
25 Tests per Kit
25 tests per kit • $10.00 per test
The OSOM® BVBLUE® Test is a CLIA-waived enzyme activity test that detects elevated sialidase activity in vaginal fluid as an aid in diagnosing bacterial vaginosis in women suspected of BV. This prescription-use test is intended for healthcare professionals and is not for home use.
- Less than 1 minute of hands-on time with results in 10 minutes
- Uses a vaginal fluid specimen collected with the included sterile swab
- Blue or green indicates a positive result; yellow indicates a negative result
- 92.8% sensitivity and 98.0% specificity versus Gram stain in a 220-patient study
- Includes 25 test vessels, sterile swabs, developer solution and instructions
| 1-5 | 6-10 | 11+ |
| $250.00 | $230.00 | $217.50 |
OSOM BVBLUE Bacterial Vaginosis Test Overview
The OSOM® BVBLUE® Test is a rapid enzyme activity test for detecting elevated sialidase activity in vaginal fluid. Sialidase is produced by bacterial pathogens associated with bacterial vaginosis, including Gardnerella vaginalis, Bacteroides species, Prevotella species and Mobiluncus species.
The test is intended for women suspected of having bacterial vaginosis, such as women with vaginal discharge typical of BV or a previous history of BV, and is used as an aid in diagnosis. Results must be considered together with other clinical and patient information.
Professional Use Only
Prescription Use
25 Tests per Kit
Features and Benefits
CLIA-waived testing for use in qualified waived settings
Less than 1 minute of hands-on time with a 10-minute reaction period
Clear color-based results without an analyzer
Detects elevated vaginal-fluid sialidase activity associated with bacterial vaginosis
Internal quality-control features are built into each test run
Sterile specimen-collection swabs are included
Product Details
GEN183
DTK-400183
183
25 Tests
K050755
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Enzyme activity test using a chromogenic sialidase substrate |
| Detected activity | Elevated sialidase activity in vaginal fluid |
| Intended use | Aid in diagnosing bacterial vaginosis in women suspected of BV |
| Specimen | Vaginal fluid collected from the lower one-third of the vaginal wall with the included swab |
| Result type | Qualitative positive or negative color result |
| Reaction time | 10 minutes at 62.6-98.6°F (17-37°C); read immediately after adding developer and mixing |
| Minimum detection limit | 7.64 U of sialidase activity |
| Regulatory status | FDA 510(k) K050755; CLIA waived |
| Intended user | Professional prescription use only; not intended for home use |
| Storage | Refrigerated at 36-46°F (2-8°C), protected from direct sunlight |
| Package size | 25 tests per kit |
What’s Included
BV Test Vessels containing the chromogenic substrate and buffer
10 mL bottle of Developer Solution
Sterile swabs for vaginal-fluid specimen collection
Directional insert
A timer and the OSOM BVBLUE Control Kit are required but are not provided. The positive and negative external controls are available separately as manufacturer Catalog No. 184.
How the Test Works
The BV Test Vessel contains a chromogenic substrate of bacterial sialidase. After the vaginal-fluid specimen reacts with the substrate for 10 minutes, Developer Solution is added. A high level of sialidase produces a blue or green color in the vessel or on the swab head, while no or very low sialidase activity produces a yellow color.
How to Perform the Test
Prepare the materials: Allow the refrigerated kit to reach room temperature. Remove one BV Test Vessel and the Developer Solution bottle, then remove the vessel cap.
Collect the specimen: Use the included swab to collect vaginal fluid from the lower one-third of the vaginal wall. Do not collect from the cervix.
Mix the specimen: Place the swab into the BV Test Vessel and gently swirl the mixture.
Allow the reaction: Let the vessel containing the swab stand for 10 minutes at 62.6-98.6°F (17-37°C).
Develop and read: Add one drop of Developer Solution, gently swirl and read the result immediately.
This abbreviated procedure does not replace the package insert. Follow the current directional insert, specimen-collection restrictions, safety precautions and quality-control requirements. The developer contains sodium hydroxide and can cause severe skin burns and eye damage.
Interpreting Results
| Result | Color | Interpretation |
|---|---|---|
| Positive | Blue or green in the vessel or on the swab head | High level of sialidase activity |
| Negative | Yellow in the vessel | Normal level of sialidase activity |
| Invalid | No blue, green or yellow result | Do not report the result; follow the package-insert instructions |
Performance Compared with Gram Stain
| Manufacturer Study | Sensitivity | Specificity |
|---|---|---|
| 220-patient comparison with Gram stain | 92.8% | 98.0% |
These are study-specific performance figures from the manufacturer’s directional insert and sales materials; they are not a blanket accuracy guarantee. A positive result indicates elevated sialidase activity, and results must be interpreted with other clinical and patient information.
Important Testing Information
Do not collect a specimen from the cervix
Do not use specimens from patients who used vaginal creams or ointments, douched, or used spermicides, vaginal lubricants or feminine sprays within 72 hours before testing
The test detects sialidase activity and does not identify yeast, parasites or every possible mixed infection
Insufficient specimen collection or antimicrobial therapy may produce a false-negative result
Use each test once and do not use materials after the labeled expiration date
Follow the manufacturer’s quality-control recommendations for each new lot, shipment and untrained operator
Storage and Specimen Handling
Store the kit refrigerated at 36-46°F (2-8°C), out of direct sunlight
Store the test vessels inside the box and allow the kit to reach room temperature before testing
Use kit contents before the expiration date printed on the outer box
Test specimens promptly; when delayed, swabs may be stored at room temperature for up to 48 hours or refrigerated for up to 7 days in a clean, dry container without transport media
Instructions and Product Documents
Frequently Asked Questions
What does the OSOM BVBLUE Test detect?
It detects elevated sialidase activity in vaginal fluid. The enzyme is produced by bacterial pathogens associated with bacterial vaginosis, and the result is used as an aid in diagnosis together with clinical and patient information.
Is the OSOM BVBLUE Test CLIA waived?
Yes. The OSOM BVBLUE Test is CLIA waived when performed according to the manufacturer’s instructions in an appropriately certified testing setting. Modifying the instructions, including quality-control procedures, changes the test’s waived status.
Can this test be used at home?
No. The package insert identifies the OSOM BVBLUE Test for professional prescription use only and states that it is not intended for home use.
How quickly are results available?
The swab remains in the test vessel for a 10-minute reaction period. After one drop of Developer Solution is added and mixed, the result is read immediately.
What do the result colors mean?
Blue or green in the BV Test Vessel or on the swab head is positive for a high level of sialidase activity. Yellow in the vessel is negative. A test that does not produce a blue, green or yellow result is invalid.
What is included in the 25-test kit?
The kit contains 25 BV Test Vessels, a 10 mL bottle of Developer Solution, sterile swabs and one directional insert. A timer and external controls are not included.
Are positive and negative controls included?
No. The OSOM BVBLUE Control Kit with positive and negative controls is sold separately as manufacturer Catalog No. 184.
How should the kit be stored?
Store the kit refrigerated at 36-46°F (2-8°C), out of direct sunlight, with the test vessels inside the box. Allow the kit to reach room temperature before use and do not use it after the expiration date.
Bacterial Vaginosis Information
For patient-focused information about bacterial vaginosis, including symptoms, risk factors and when to contact a healthcare provider, review the CDC resource.
Additional information
| Weight | 0.7 lbs |
|---|---|
| Dimensions | 10 × 10 × 5 in |
| Quantity | 1 to 5, 6 to 10, 11+ |
