Product Manual

ManualsBrandsSekisui Diagnostics ManualsRapid TestsOsom® Bvblue® Control Set - 10/kt

BVBLUE

Test

17°– 37°C

(62.6°– 98.6°F)

POSITIVE NEGATIVE

Collect a vaginal

ﬂuid sample with a swab.

Contact the swab with

the lower one-third of the

vaginal wall. Collect as

much ﬂuid as possible.

Put the swab into the

BV Test Vessel. Gently

swirl the mixture.

Let the BV Test Vessel

containing the swab

stand for 10 minutes

between 17˚ and 37˚C.

Add one drop of

Developer Solution

to the BV Test Vessel

containing the swab.

Gently swirl the mixture.

Read the results immediately.

CAUTION: The Developer

Solution is a dilute alkaline

solution. This may cause skin

and eye irritation. If the

solution comes in contact

with the skin or eyes, ﬂush

with large volumes of water.

INTERPRETATION OF TEST RESULTS:

There are two possible results:

(a) positive result or (b) negative result

NOTE: You may need to remove the swab to read

the test results.

A Positive Result shows a high level of sialidase

activity. A Negative Result shows a normal level

of sialidase activity.

Warning: Read the Directional Insert prior to performing the test.

Negative Result:

A yellow color

in the BV Test

Vessel.

Positive Result:

A blue or green

color in the

BV Test Vessel

or on the head

of the swab.

QUICK REFERENCE INSTRUCTIONS

Summary of content (10 pages)

PAGE 1
Collect a vaginal fluid sample with a swab. Contact the swab with the lower one-third of the vaginal wall. Collect as much fluid as possible. Put the swab into the BV Test Vessel. Gently swirl the mixture. Let the BV Test Vessel containing the swab stand for 10 minutes between 17˚ and 37˚C. 17°– 37°C (62.6°– 98.6°F) Warning: Read the Directional Insert prior to performing the test. Add one drop of Developer Solution to the BV Test Vessel containing the swab.
PAGE 2
NOTE: Allow the kit to come to room temperature before running the test. Store the kit refrigerated, 2° – 8°C (36°-46°F), out of direct sunlight. Store vessels inside the box. Kit contents are stable until the expiration date printed on the outer box. STORAGE AND STABILITY: • Developer solution contains an sodium hydroxide solution. The use of nitrile or latex gloves, wearing protective eye wear, and clothing is recommended when handling the reagent within this kit.
PAGE 3
® BVBLUE® Test CLIA Complexity: Waived For facilities in the US: A CLIA Certificate of Waiver is needed to perform testing in waived settings. Read all instructions carefully before use. If a laboratory modifies the following test instructions including Quality Control, the test will be considered High Complexity and no longer considered Waived.
PAGE 4
WARNINGS AND PRECAUTIONS: • For in vitro diagnostic use only. • Do not use after the expiration date printed on the kit. • Do not store the kit at temperatures above 8°C (46°F). • Do not store the kit in strong light. • F ollow your laboratory safety guidelines in the collection, handling, storage and disposal of patient specimens and all items exposed to patient specimens. • Used tests should never be re-used. • This product is intended for vaginal fluid use only.
PAGE 5
If the controls still do not perform as expected contact Sekisui Diagnostics Technical Service at 1-800-332-1042. 2a. For CLIA Waived Labs You should follow the guidelines below for QC testing. The manufacturer recommends that external controls be run with each new lot, each new shipment and with each new untrained operator. 2b. For CLIA Non-Waived Labs Quality Control requirements should be established in accordance with local, state and federal regulations or accreditation requirements.
PAGE 6
TABLE 1. RESULTS OF A STUDY OF 113 WOMEN Patient Type Mean Vaginal Fluid Sialidase Activity Patients with BV (n=28) 12.3 U (95% CI 8.1 – 16.6 U) Healthy Controls (n= 65) 2.7 U (95% CI 2.2 – 3.2 U) Patients with Candidiasis (n=17) 3.7 U (95% CI 2.6 – 4.8 U) Patients with Trichomoniasis (n=3) 1.99 U (95% CI 0.6 – 3.4 U) PERFORMANCE CHARACTERISTICS: MINIMUM DETECTION LIMIT (MDL): The OSOM BVBLUE Test was evaluated by different users using control samples to demonstrate the MDL of 0.25 µg (7.64 U).
PAGE 7
MIXED INFECTIONS: The OSOM BVBLUE Test was investigated in 255 patients stratified by clinical diagnosis. The results of this study are presented in TABLE 4. TABLE 4. RESULTS OF OSOM BVBLUE IN PATIENTS STRATIFIED BY CLINICAL DIAGNOSES No. of Patients Clinical Diagnosis Amsel Criteria BVBLUE Wet Mount BV Yeast Trich Positive 5 + + – 4 2 + – + 2 4 – – + 0 41 – + – 0 50 + – – 48 153 – – – 9 Total (255) 57 46 6 63 TABLE 5.
PAGE 8
FIGURE 1. ASSOCIATION BETWEEN GRAM’S STAIN SCORE AND TEST RESULTS FROM OSOM BVBLUE AND AMSEL CRITERIAa Cumulative Test Results 30 Cumulative Samples 25 BVBLUE Positive Samples 20 Amsel Positive Samples 15 10 5 0 1 2 3 4 5 6 7 8 9 10 Gram’s Stain Score a Gram’s stains scored using Nugent method. (13) TABLE 6. PERFORMANCE OF OSOM BVBLUE COMPARED TO GRAM’S STAIN Sample Type Correct Incorrect Agreement (95% CI) All patients tested (n=220) (P<0.0001) 212 8 96.4% (93.9 – 98.
PAGE 9
REFERENCES: 1. Hillier, S.L. Diagnostic microbiology of bacterial vaginosis. Am. J. Obstet. Gynecol. 1993; 169:455. 2. Eschenbach, D.A. History and review of bacterial vaginosis. Am. J. Obstet. Gynecol. 1993; 169:441. 3. Hill, G.B. The microbiology of bacterial vaginosis. Am. J. Obstet. Gynecol. 1993; 169:450. 4. B riselden, A.N.; et al. Sialidases (neuraminidases) in bacterial vaginosis and bacterial vaginosis-associated microfluora. J. Clin. Microbiol. 1992; 30:663. 5. Faro, S.; et al.
PAGE 10
GHS CLASSIFICATION AND LABEL ELEMENTS Component (s) Pictogram Developer Precautionary Statement (s) Signal Word Hazard Statement Danger H314: Causes severe skin burns and eye damage P260: Do not breathe dust / fume / gas / mist / vapors / spray P264: Wash hands thoroughly after handling. P280: Wear protective gloves/protective clothing/eye protection/face protection P301+P330+P331: IF SWALLOWED: Rinse mouth. DO NOT induce vomiting.