【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.
【Test procedure】
1. Before the test, please read the instructions completely. If the
test card and sample are stored in cold storage, they should be
balanced at room temperature (15-30)℃ for not less than 30min
before use.
2. Start NIR-1000 dry fluoroimmunoassay analyzer and correctly
select the corresponding sample type on the instrument.
3. Take out the ID card, make sure that the batch number of the ID
card is consistent with that of the test card, and insert the ID
card into the ID card port of the instrument.
4. Unscrew the fecal collection tube, use the fecal collection rod
to take feces, place the fecal collection rod in the tube, screw
the tube cover, shake the tube up and down for several times, and
fully mix the sample.
5. Take out the test card from the aluminum foil bag and use it
within 15 minutes.
6. Place the test card on a clean horizontal table and mark it
horizontally.
7. Apply 100 µL (or 3 drops) of diluted samples to the well of the
test card.
8. Insert the test card into NIR-1000 dry fluoroimmunoassay
analyzer and click the “instant test” button to read the results at
10 minutes after addition of samples.
【Reference interval】
The minimum detection limit of hemoglobin is not higher than 0.20
µg/mL.
The minimum detection limit of transferrin is not higher than
0.04μg/mL.
【Performance】
1. Limits of detection
Hb: No higher than 0.2 µg/mL; TRF: No higher than 0.04 µg/mL
2. Coincidence rate
10 pcs of positive quality control are been tested, the positive
coincidence rate of Hb and TRF is not less than 90%. 10 pcs of
negative quality control are been tested, the negative coincidence
of Hb and TRF rate is not less than 90%.
3. Repeatability
Test positive quality control and negative quality control 10 times
in parallel, the result of Hb and TRF were basically the same, with
a repetition rate of ≥90.0%, and the coefficient of variations of
Hb and TRF are within 15.0%.
4. Batch-to-batch variation
3 batches of cassettes are randomly selected, 10 cassettes in each
batch. Test positive quality control, the coefficient of variations
of Hb and TRF are within 15.0%.
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. |
