【Product name】 FOB.pdf
Fecal occult blood (FOB) Rapid Test(Fluorescence immunoassay)
【Intended use】
This kit is used for quantitative determination of CEA in human
whole blood, plasma and serum.
Carcinoembryonic antigen (CEA) is a tumor associated antigen, first
described in 1965 by Gold and Freedman1. It is a cell-surface
glycoprotein with a molecular weight of 180-200kD, that occurs in
high levels in colon epithelial cells during embryonic development.
Levels of CEA are significantly lower in colon tissue of adults,
but can become elevated when inflammation or tumours arise in any
endodermal tissue, including the gastrointestinal tract,
respiratory tract, pancreas and breast.
An over expression of CEA protein has been detected in a variety of
adenocarcinomas, including gastric, pancreatic, small intestine,
colon, rectal, ovarian, breast, cervical and non-small-cell lung
cancers. CEA is also expressed by epithelial cells in several
non-malignant disorders, including diverticulitis, pancreatitis,
inflammatory bowel disease, cirrhosis, hepatitis, bronchitis and
renal failure and also in heavy smokers.
Therefore CEA should not be regarded as a tumour-specific marker
for the screening of a general population for undetected cancers.
However, the determination of CEA levels provides important
information about patient prognosis, recurrence of tumours after
surgical removal and effectiveness of therapy.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is
valid for 18 months. The test card should be used within 15 minutes
after unsealing under the environment of 15℃~30℃ and 20% ~ 90%
relative humidity.
The production date, batch number and expiration date are shown in
the outer package of the product.
【Applicable instruments】
Nir-1000 dry fluorescent immunoassay analyzer produced by WWHS
Biotech. Inc.
Other WWHS
Assay Items
| Gastrointestinal | | | | | |
| cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
| 36 | FOB | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| 37 | TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| 38 | FOB+TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
