SAA Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence
Immunoassay for the quantitative determination of serum amyloid A protein (SAA) in
serum, plasma or whole blood. It is mainly used to the diagnosis of infection and
disease evaluation.
【SUMMARY】
Serum amyloid A (SAA) is an acute phase protein with a relative molecular weight of
12,000. It is mainly produced by liver cells, but can also be produced outside the liver,
such as the heart and skeletal muscle. Although both SAA and C-reactive protein (CRP)
are acute-phase proteins, the detection of SAA is more conclusive than the detection of
CRP in patients with viral infections, severe acute pancreatitis, and rejection reactions
to kidney transplants.1 After the human body is infected, it can rapidly increase by about
1000 times within 4-6 hours, and the half-life is 50 minutes.2 After the pathogen is
cleared. It can quickly drop to a normal level. It is a sensitive indicator that reflects the
recovery of body infection and inflammation; the reference range of serum SAA is
<10 mg/L, and its core clinical value lies in the identification of viral infections.
【PRINCIPLE】
SAA Test Cassette detects serum amyloid A protein (SAA) based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad.
If the specimen contains SAA, it attaches to the fluorescent microspheres-conjugated
anti-SAA antibodies. Then the complex will be captured by the capture antibodies
coated on the nitrocellulose membrane (Test line). The concentration of SAA in the
sample correlates linearly with the fluorescence signal intensity captured on the T line.
According to the fluorescence intensity of the test and standard curve, the
concentration of SAA in the sample can be calculated by
Analyzer to show SAA
concentration in specimen.
【REAGENTS】
The test includes anti-SAA antibody coated fluorophore and anti-SAA antibody coated
on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing
such as laboratory coats, disposable gloves and eye protection when specimens
are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The SAA Test Cassette should only be used with the Analyzer by approved medical
professionals.
【STORAGE AND STABILITY】
1. The test should be stored at 4-30 °C until the expiry date printed on the sealed
pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the test from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
1. Collect the specimens according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Serum and
Plasma specimens may be stored at 2-8 °C for up to 5 days, for long term storage,
specimens should be kept below -20 °C. Whole blood collected by venipuncture
should be stored at 2-8 °C if the test is to be used within 2 days of collection. Do not
freeze whole blood specimens. Whole blood collected by finger stick should be
tested immediately.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and
thawing of specimens. Only clear, non-hemolyzed specimens can be used.
4. EDTA, Sodium citrate, can be used as the anticoagulant tube for collecting the
blood specimen.
Sample Dilution/Sample Stability
1. The specimen (10 μL of serum/plasma/whole blood) can be added directly with the
micro pipette into the buffer.
2. Close the tube and shake the sample by hand vigorously for approximately 10
seconds to mix the sample and dilution buffer.
3. Let the diluted sample homogenize for approximately 1 minute.
4. The diluted sample can then be used immediately or stored for up to 8 hours.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge
• Fluorescence Immunoassay Analyzer
• Pipette
• Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer User Manual for the complete
instructions on use of the analyzer. The test should be conducted at room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature
(15-30 °C) prior to testing.
1. Turn on the Analyzer power.
2. Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or
sample type according to needs.
3. Remove the test cassette from the sealed foil pouch and use it within 1 hour. Best
results will be obtained if the assay is performed immediately after opening the foil
pouch.
4. Place the test on a flat and clean surface.
Pipette 10 μL of serum/plasma/whole blood into the buffer tube; mix the
specimen and the buffer well. Let the diluted sample homogenize for approximately
1 minute.
5. Pipette 75 μL of diluted specimen into the sample well of the cassette. Start the
timer at the same time.
6. Test results should be interpreted at 15 minutes with the use of Fluorescence
Immunoassay Analyzer.
Caution: There are different test modes of the Fluorescence Immunoassay Analyzer.
The difference between them is incubation of the test cassette is outside or inside the
analyzer. Choose test mode accordingly and confirm sample type. Consult the user
manual of the analyzer for detailed operation information.
Operator must consult the Fluorescence Immunoassay Analyzer User Manual prior to
use and become familiar with the processes and quality control procedures.
【INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for SAA is calculated by Fluorescence Immunoassay Analyzer and
display the result on the screen. For additional information, please refer to the user
manual of Fluorescence Immunoassay Analyze.
Assay range of SAA is 1 - 300 mg/L.
