Description
Instructions
Rheumatoid Factor Test Kit (Colloidal Gold)
detects the amount of Rheumatoid Factor (RF) consists in human
blood quantitatively. Positive Rheumatoid Factor normally can
be found in rheumatoid arthritis, besides it can be found in virus
diseases like hepatitis, tumour, phthisis, subacute bacterial
endocarditis and the other autoimmune diseases. The minimum
detectable amount of RF of the product is *0IU / ml.
Product name
Common name: Rheumatoid Factor
Detection Test Kit (Colloidal Gold)
Name of commodity: Rheumatic
Detection Kit
English name：Rheumatoid Factor Test
Kit (Colloidal Gold)
Principle
Rheumatoid Factor Detection Test Kit (Colloidal Gold) is made
by using colloidal gold immune chromatography principle; the
rheumatoid factor conjugates with colloidal gold marker, then the
conjugatespecific binding with rheumatoid factor
antibody on the test strip to emerge the test line (T line).
The dissociative colloidal gold marker move to the control
area to combine with corresponding antibody displays control line
(C line).
Structure
Composition
Rheumatoid Factor Test Kit (Colloidal Gold) consists of the
board and a disposable sample tube. The detecting plate
contains colloidal gold marker and anti-rheumatoid factor Colloidal
gold marker and the other ingredients.
Method of
use;
Sampling: sampling test subjects venous blood 1ml,
serum obtained after centrifugation
Test: Place the test
board on a flat table, add 3 drops of the patient's serum or plasma
on the test paper by using a disposable sample tube
Read the results: Read the result in *0 minute after
the test, the result is invalid after *0 minutes.
The
Interpretation of Test Results
Positive: Two purple lines
appears on the test paper in T area and C area On the test paper
respectively; the quicker the T line appears and the darker the
color is, the higher amount of rheumatoid factor are in the
sample.
Negative: Only C line appears
when the result is negative; the sample does not contain rheumatoid
factor.
Invalid:The test is invalid
when C line does not appear. Take a second test.
Cautions
1. This product is only used for in vitro diagnosis, and
please use a quantitative reader by our company if a quantitative
result is needed.
2. The product is for one time use only. Do not use it
repeatly.
3. Read the instructions and check the expiry date on the
aluminum bag carefully before use, stop using the product if the
aluminum bag is damaged.
4. Use it properly.
Limitations
The test result of the product
cannot be used as the sole criterion, and it is only a doctors’ or
patients’ reference with comprehensive judgment.
Packaging Specifications
1 cassette/ bag/ box, *0
cassette/box, *0 cassette/box, *0 cassette/box, *0 cassette/box,
**0 cassette/box.
Expiry Period: *4 months
Storage and Transportation
Packed rheumatoid factor test kit
(colloidal gold) should be stored in a 4 - *0 Celsius degree, cool,
dark, and dry room.
Major Prohibit: None
Executive standard:YZB/ E
********2
Registration Certificate of Medical Device
(RCMD):E RCMD ***9 ******3
Manufacture Permit of Medical Device
(MPMD):E MPMD *******8
