standard f ifob fia - asker.cz · cv% cut-off value storage condition quantitative measurement of...
TRANSCRIPT
iFOB FIASTANDARD F
Product Specification
Intended use
Specimen type
Specimen volume
Measurement range
Measuring time
CV%
Cut-off value
Storage condition
Quantitative measurement of human Hb level for screening of GI-tract bleeding
Faeces
3 drops
25 – 1,000 ng/mL (5-200 ug Hb/g faeces)
5 mins
<10%
<100 ng/mL (25 ug Hb/g faeces)*Available to set different cut-off values by the clinician
2 – 30°C / 36 - 86°F (Room temperature)
Ordering Infomation
Category
Tumormarkers
Product
STANDARD F iFOB FIA
STANDARD F iFOB FIA
iFOB Control
Pack Size
20 Tests
50 Tests
Lv1 X 10 / Lv2 X 10
CAT No.
10IFO10B
10IFO10C
10IFOC10
STANDARD™ F iFOB FIA is a highly sensitive fluorescent immunoassay test for the quantitative measurement offaecal occult blood level in faeces. · Early detection of lower GI-tract bleeding· Easy & fast test procedure · Up to 60 tests/hour with F2400 Analyzer
Fast & Reliable Quantitative Faecal Occult Blood Detection
Convenient Sample collection & Test procedure
STANDARD F iFOB FIA
Reliable
Head Office C-4&5Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Tel +82-31-300-0400 | Fax +82-31-300-0499 | E-mail [email protected] | Website www.sdbiosensor.com
LEF-FIFOB-EN_Rev.01/2018.10 © 2018 SD BIOSENSOR. All rights reserved.SD Biosensor is not related to Alere Inc. or to Standard Diagnostics, Inc.
• Wide range quantitative FOB test (25 – 1,000 ng/mL) • Individual cut-off value is able to set by the clinician according to the medical or geological circumstances• Only detect human Hb – no dietary restriction prior testing
Fast & Easy
High throughput quantitative iFOBT with F2400 Analyzer
Sample collection procedure
• Final result within 5 mins• Convenient sample collection tool • Simple test procedure – no need special training
Open the green cap-stick, and stab 5-6 sites of the faecal sample. (Do not scoop the sample)
1 Close the green cap tightly, and shake the tube several times vigorously.
2 Write the patient information on the Patient ID Label, and attach it on the Sample collection tube.
3 Store the Sample collection tube into the zipper bag provided, and submit it to your healthcare provider.
4
Up to 60 tests/hour
LIS/HIS Connectivity
Various other parameters
TM
2°C(36°F)
30°C(86°F)
Sample Collection Tube
Patient Name (ID) :Date :
iFOB FIA Assay Diluent
xxxxxxxxxxxx
xxx.xx.xx xxx.xx.xx
TM
2°C(36°F)30°C(86°F)
Sample Collection TubePatient Name (ID) :Date :
iFOB FIA Assay Diluent xxxxxxxxxxxxxxx.xx.xx
xxx.xx.xx
TM
2°C(36°F)
30°C(86°F)
Sample Collection Tube
Patient Name (ID) :Date :
iFOB FIA Assay Diluent
xxxxxxxxxxxx
xxx.xx.xx xxx.xx.xx
Sample Collection Tube BagOpen the blue cap of the Sample
collection tube.
Sample collection procedure can affect test results.
Please collect fecal sample appropriately as below.
Stab 5 – 6 sites of the fecal sample
using the cap-stick. (Do not scoop the
fecal sample)
Close the cap tightly, and then shake
the tube several times vigorously.Store the Sample collection tube into
the zipper bag provided. Then, submit
it to your healthcare provider.
Sample mixture is able to leak if the white cap
is opened. Please do not open the white cap
while collecting the sample.
Storage condition : Collected sample tube can be stored
in room temperature for 3 days. If you need to store it more
than 3 days, please store it in the refrigerator (2~8°C).
1)
2)
3)
4)
1)
2)
3)
4)
CAUTION
Specimen Information (검체 정보)
˙ Date (채취 일자) :
˙ Patient name (피검자 성명) :
˙ Age (나이) :
˙ Sex (성별) :
Patient Name (ID) :Date :
TM
2°C(36°F)
30°C(86°F)
Sample Collection Tube
iFOB FIA Assay Diluent
xxxxxxxxxxxx
xxx.xx.xx xxx.xx.xx
Test procedure
Insert a iFOB FIA test device into the testing slot.
1 Dispense 3 drops of sample mixture into the sample well of the test device.
3 After applying the sample, press the START button immediately.The analyzer will automatically display the test result within 5 minutes.
4
Patient Name (ID) :Date :
TM
2°C(36°F)
30°C(86°F)
Sample Collection Tube
iFOB FIA Assay Diluent
xxxxxxxxxxxx
xxx.xx.xx xxx.xx.xx
Zika
Ag
iFOB
3<F100> <F200> <F2400>
Shake the Sample collection tube several times, and open the white cap.
2