TABLE 10.
Manufacturer/distributor | Device | Specimen stability and temperature information |
---|---|---|
Eiken*/Polymedco† | OC-Auto Micro 80 FOB Test System | Manufacturer states specimens are stable for 15 days at 15°C–30°C and 30 days at 2°C–8°C. |
Eiken/Polymedco | OC-Sensor DIANA IFOB Test System | There are also data that show the specimen can be kept for less than 3 days at 29°C–34°C but can be kept for at least 10–14 days at −18°C to −24°C |
Alfresa Pharma Corporation‡/Inverness Medical§ | I-FOBT Hemoglobin NS-Plus | Manufacturer’s marketing materials indicate the specimen is 95% stable for 7 days at 25°C, after 2 days at 37°C stability drops to 90% then to 80% after 7 days, stable for 30 days at −40°C, and after 2 days at 7°C stability drops to 90% but stays at this for 20 days |
Beckman Coulter¶ | Hemoccult ICT, Immunochemical Fecal Occult Blood Test (also known as Flexsure OBT) | Manufacturer instructions say specimen is stable after sampling for 14 days at 15°C–30°C |
Eiken/Polymedco | OC-Light Manual IFOBT | Manufacturer states the specimen is stable for 15 days at 15°C–30°C or 30 days at 2°C–8°C |
Inverness Medical | Clearview Ultra FOB Test | Manufacturer states that specimen can be stored at 15°C–30°C for up to 5 days or 2°C–8°C for up to 14 days. |
Medix Biochemica** | Actim Fecal Blood Test | Manufacturer states that specimen is stable for up to 7 days at 2°C–25°C |
PSS World Medical†† | Consult Diagnostic Occult Blood Test Extra Sensitive | Unknown. |
Artron‡‡ | One Step Fecal Occult Blood Test | Manufacturer instructions state the test should be developed immediately and read within 10 min to 15 min. No information on storage if not developed immediately. |
IND Diagnostic§§/BTNX¶¶ | Rapid Response One-Step Fecal Occult Blood Test | Manufacturer instructions state if not developed straight away the specimen is stable up to 7 days at 37°C. This is intended to be a physician-developed test (although not licensed for this currently) but is suitable and licensed for laboratory development |
Tremblay Harrison*** | Minute Lab Fecal Occult Blood Test Device | Manufacturer instructions intend for the test to be developed within 6 h of collecting specimen; if not developed within 6 h, specimen is stable at 2°C–8°C for 3 days |
WHPM Bioresearch & Technology††† | Hemosure Immunological Fecal Occult Blood Test | Manufacturer instructions intend for the test to be developed by the patient immediately but if not the specimen is stable at 2°C–8°C but they do not state for how long |
Innovacon‡‡‡ | FOB One Step Fecal Occult Blood Test | Manufacturer instructions intend for the test to be developed by the patient within 1 h, but if not it will be stable for 3 days at 15°C–30°C |
Eiken Chemical Company Ltd, Japan;
Polymedco Inc, USA;
Alfresa Pharma Corporation, Japan;
Inverness Medical, Canada;
Beckman Coulter Inc, USA;
Medix Biochemica, Finland;
PSS World Medical Inc, USA;
Artron Bioresearch, Canada;
IND Diagnostic Inc, Canada; BNTX Inc, Canada;
Tremblay Harrison Inc, USA;
WHPM Bioresearch & Technology Inc, USA;
Innovacon Inc, USA. FOB Fecal occult blood