The AFP Test Cassette (Serum/Plasma) is based on Fluorescence immunoassay for the
quantitative detection of Alpha-Fetoprotein in serum or plasma.
【SUMMARY】
Alpha-Fetoprotein (AFP) is normally produced during fetal and neonatal development by the
liver, yolk sac and in small concentrations by the gastrointestinal tract.1 By the second year
of life, AFP concentrations decrease rapidly, and thereafter only trace amounts are normally
detected in serum.2 In general, normal adults have serum AFP concentrations of less than
10ng/ml.3 Elevated AFP levels occur in several malignant diseases including hepatocellular
carcinoma, testicular nonseminomatous origin, and occasionally of other entodermal origin.4
AFP has also been used to detect early tumors in people at high risk for liver cancer.
Studies of patients with large hepatic metastases or viral hepatitis also indicate slightly
elevated or persistent AFP values.5 In areas where liver cancer is common, the use of AFP
tests for screening has resulted in the detection of many tumors at an earlier stage.6
Detection of elevated AFP levels can also be used in the detection of fetal open neural tube
defects.7
【PRINCIPLE】
The AFP Test Cassette (Serum/Plasma) detects AFP based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad If the
specimen contains AFP, it attaches to the fluorescent microspheres-conjugated anti-AFP
antibodies. Then the complex will be captured by the capture antibodies coated on the
nitrocellulose membrane (Test line).The concentration of AFP in the sample correlates with
the fluorescence signal intensity captured on the T line. According to the fluorescence
intensity of the test and standard curve, the concentration of AFP in the sample can be
calculated by
Analyzer to show AFP concentration in specimen.
【REAGENTS】
The test cassette contains anti-AFP antibody coated fluorphores and anti-AFP 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 AFP 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】
Sample Taking
Collect the specimen according to standard procedures.
Do not leave specimens at room temperature for prolonged periods. Serum and plasma
specimens may be stored at 2-8 °C for up to 3 days, for long term storage, specimens
should be kept below -20 °C.
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.
EDTA, Heparin sodium can be used as the anticoagulant tube for collecting the specimen.
Sample Dilution / Sample Stability
Transfer 50 μl of serum or plasma to the buffer tube with the micro pipette.
Close the tube and shake the sample by hand vigorously for approximately 10 seconds
to mix the sample and dilution buffer.
Let the diluted sample homogenize for approximately 1 minute. The 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 Operation Manual for the
complete instructions on use of the Test. The test should be in room temperature.
Allow the test cassette, specimen, buffer and/or controls to reach room temperature
(15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or
“Quick test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. Pipette 50 μl of serum or plasma into the buffer tube, mix the specimen and the buffer
well.
4. Pipette 75 μl diluted sample into the sample well of the cassette. Start the timer at the
same time.
5. There are two test modes for Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample,Insert the test cassette into the
Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST"
immediately. The Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time, The Analyzer will automatically countdown 15 minutes. After
the countdown, the Analyzer will give the result at once.
【INTERPRETATION OF RESULTS】
Results read by Fluorescence Analyzer.
The result of test for AFP 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 Analyzer.
Linearity range of AFP is 5-400 ng/mL.
Reference range: ＜20 ng/ml.
