Ossur America 200020 - Status iFOBT Control Set - POS & NEG, 20", Each
Status iFOBT Control Set - POS & NEG
For the Qualitative Detection of Immunochemical Fecal Occult Blood(Human Hemoglobin in Human Fecal Specimens)
- CLIA Waived
- Superior sensitivity and specificity
- Human hemoglobin specific for reducing false positives
- Easy one-step test procedure
- Specimen can be collected in office or at home
- Patient friendly and easy-to-follow instructions
- Non-invasive collection method
- Only one test device needed
- No dietary or drug restrictions for iFOBT
Status iFOBT Control includes a Positive Control containing stabilized human hemoglobin and a Negative Control containing a buffer. Status iFOBT Controls should only be used with Status iFOBT tests.
Warnings and Precautions ofStatus iFOBT Control Set
- The Positive Control is the vial with the Red Cap and the Negative Control is the vial with White Cap. Do not exchange the caps of the vials.
- The Status iFOBT Positive and Negative Control Vials should be stored at 2oC- 30oC and can be used until the labeled expiration date.
- For in vitro diagnostics use for professional and Laboratory use only.
- Do not use the controls beyond the expiration dates.
- Handle as if capable of transmitting hepititis.For in vitro diagnostic use only. Not for internal use by humans or animals
Reagents
Status iFOBT Control Positive Control (1.0 ml) is liquid and ready to use. WARNING: Contains Human serum with 0.1% Sodium azide. For in vitro diagnostic use only. Contents sterile until opened.
Status iFOBT Control Negative Control (1.0 ml) is liquid and ready to use. WARNING: Contains Human serum with 0.1% Sodium azide. For in vitro diagnostic use only. Contents sterile until opened.
Directions for Use
Allow the test and the controls to equilibrate room temperature 59 -86oF (15- 30oC) prior to testing.
- To begin the testing, open the sealed pouch of the sealed pouch of the Status iFOBT test by tearing the pouch. Remove the test kit from the pouch and use it as soon as possible.
- Squeeze 3 drops of the Positive Control in to the sample well of the Status iFOBT Cassettes.
- Repeat the same procedure for Negative Control.
- The results should be read at five minutes. DO NOT INTERPRET RESULTS AFTER 10 MINUTES.
Expected Results
- Read results at 5 minutes
- Do not read results beyond 10 minutes
- Even if a very faint color band appears in the test region, it should be considered a positive result
Negative Control Results:
Only one Colored band appears on the Control Region. No apparent band on the Test Region.
Positive Control Results:
Color bands appears on the control and test regions. Even if a very faint colored band appears in the test region it should be considered as positive result.
