Bi-State Blood Culture Bottle IFU September 26,2011
Bi-State Blood Culture Bottle IFU September 26,2011
Microbiological Assay
M0601
20 tests
OBELIS S.A
Bd. Général Wahis, 53
1030 Brussels
Belgium
Materials Required but not Provided 1. Store all components at 4-25 ℃. Avoid strong light.
2. The test kit may be used throughout the expiry date. Refer to the
1. Incubator (35-37 ℃) package label for the expiry date.
1. For professional use only. 1. Collect approximately 3-5 ml of adult patients’ blood per bottle
2. Follow the instruction for use carefully. Reliability of assay results with a needle and syringe or 1-3 ml of infant patients’ blood.
cannot be guaranteed if there are any deviations from the 2. Collect samples prior to initiating antibiotic therapy. If this is not
instructions in this package insert. possible, draw the blood immediately before administering the next
3. Refer to the material safety data sheet and product labeling for any dose.
3. Collect samples before meals, since hyperlipemia may obscure
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Bi-state Blood Culture Bottle
visible evidence of bacterium growth in the liquid medium. 2. Some pathogenic bacteria, especially Haemophilus influenza and
4. Since bacteremia is intermittent, collect samples at the proper time. Neisseria gonorrhoeae may have already grown in Bi-state Blood
5. Test the samples immediately once received. Culture Bottle but do not appear so. In this case, the physician
should pick some of the culture broth each day and streak on a
Reagent Preparation chocolate blood agar plate, then place into a 3–5% CO2 incubator
calibrated at 35–37 ℃ (blind passage), until the 7th day.
Bring all reagents to room temperature (18-25 ℃) prior to use
Performance Characteristics
Measurement Procedure
1. Analytical Sensitivity
1. Check if the bottle is contaminated or broken. 5 panel members (100 µl of culture medium containing 1.5 × 103 CFU/ml
2. Prepare and label the appropriate blood culture bottle. Micrococcus luteus (CMCC (B)® 28001), 150 CFU/ml Haemophilus
3. Do not unscrew cap. Remove the plastic top of the screw cap on influenza (ATCC® 10211), 1.5 × 108 CFU/ml Streptococcus pneumonia
the blood culture bottle. (ATCC® 49619), 1.5 × 103 CFU/ml Candida albicans (ATCC® 10231) and
4. Disinfect the visible part of the rubber plug with iodine or ethyl 150 CFU/ml Streptococcus pyogenes (ATCC® 19615)) were tested at
alcohol (70%) and allow drying. 35-37 ℃. Turbidity or evident turbidity in the liquid state or bacteria
5. Inject blood, ascites or cerebrospinal fluid into the culture bottle colonies in the solid state was observed after 24 hours.
after being collected with aseptic operations. Then disinfect the 2. Measurement Accuracy by Correlation
rubber plug again and replace the plastic top. A study was performed where samples were tested using this assay and
6. After the inoculation, lean the bottle several times, and incubate it the bioMérieux® assay. Data were analyzed and are summarized in the
erectly at 35-37 ℃ for 24 hours. following table.
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Bi-state Blood Culture Bottle