Alpha Fetal-protein AFP Rapid Test Kit in Cancer Diagnosis Blood Cassette
INTENDED USE
The AFP Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of alpha fetal-protein (AFP) in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of various cancers.
INTRODUCTION
Alpha fetoprotein (AFP) is a single chain glycoprotein with a molecular weight of approximatively 70,000. It is produced by the fetal yolk sac and proximal structures of the liver and gastrointestinal tract. In the human fetus, AFP is a major serum protein which reaches a level of several milligrams per milliliter at week 12 of gestation and then drops to trace concentration in the normal non pregnant adult. The clinical value of AFP as a tumor marker was not immediately appreciated because the assays used for quantitation were not sensitive enough to detect the nanogram amounts associated with early disease. As more sensitive radioimmune assays became available, the utility of AFP as a tumor marker became increasingly apparent. Significant increases are observed in malignant tumours in childhood, such as hepatoblastomas and nephroblastomas, and in hepatocellular carcinoma and certain testicular tumours in adults. Less commonly, malignant tumours of the gastro¬intestinal tract and other organ systems with massive hepatic metastases are associated with increased concentractions of AFP in serum or plasma. AFP levels should be measured at presentation and monitored during treatment and they are very useful in diagnosis and in evaluating the effectiveness of therapy.
PRINCIPLE
The AFP Rapid Test Device (Whole Blood/Serum/Plasma) detects alpha fetal-protein (AFP) through visual interpretation of color development on the internal strip. AFP antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with AFP antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient AFP antigens in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
MAIN CONTENTS
• Rapid test Cassette with desiccant.
• Disposable pipettes.
• Buffer.
• Instructions for use.
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.
SAMPLE COLLECTION
1) The AFP Rapid Test Kit is intended for use with human whole blood, serum, or plasma specimens only.
2) Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
3) Perform testing immediately after specimen collection. 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. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
4) Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
5) 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.
6) If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
7) Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
OPERATION
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2) Transfer 3 drops of whole blood/serum/plasma to the specimen well (S) of the device with the provided disposable pipette, and start the timer.
OR
Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3) If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).
4) Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION
POSITIVE:
Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE:
Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID:
Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
PERFORMANCE
Sensitivity 99.3%
Specificity 99.0%
FRQ:
| 1 |
What does an alpha fetoprotein test for? |
An AFP blood test is used during pregnancy to check the baby's risk of birth defects and genetic disorders, such as neural tube defects or Down syndrome. The test does not diagnose any health conditions. |
| 2 |
What if alpha fetoprotein is high? |
High levels of AFP may be a sign of cancer of the liver, ovaries, or testicles. But having a high AFP level doesn't mean you have cancer or that you will get cancer. Liver injury and liver diseases that aren't cancer can also cause high AFP levels. |
| 3 |
What AFP levels indicate cancer? |
Generally, an AFP level between 0 ng/mL to 10 ng/ml or even up to 40 ng/mL can be normal for adults But normal levels vary, so talk with your healthcare provider about what your results mean for you. An extremely high level of AFP in your blood—greater than 400 ng/mL—could be a sign of liver tumors. |
| 4 |
What is the AFP normal range? |
In healthy adults, serum AFP level typically falls into the range of 5–10 ng/mL [7]. On the other hand, an elevated serum level of AFP is frequently associated with HCC or other liver diseases. Studies have shown that an AFP level above 400 ng/mL can generally be considered as diagnostic for HCC. |
| 5 |
What happens if an AFP test is positive? |
A positive AFP PLUS test means that you are in a higher likelihood group for having a baby with a neural tube defect or a chromosome abnormality. However, it does not prove by itself that there is anything wrong with the pregnancy. |
| 6 |
What causes a positive alpha fetoprotein? |
The following conditions may lead to elevated AFP levels in non-pregnant females or males:
Hepatocellular cancer.
Metastatic liver cancer.
Liver cirrhosis.
Hepatitis.
Germ cell tumors.
Yolk sac tumor.
Ataxia-telangiectasia. |
| 7 |
Does fatty liver increase AFP? |
This study also found that persistent liver inflammation, regeneration, and/or fibrosis may be responsible for elevated serum AFP levels in patients with severe fatty liver disease (FLD), which was most likely secondary to cell necrosis or cytokine stimulation leading to AFP production. |
| 8 |
What is the function of alpha-fetoprotein in the liver? |
AFP is a protein that is present in patients with liver disease. AFP is also a "tumor marker" and may be used to see if a patient has liver cancer. (Liver cancer is also called hepatocellular carcinoma). |
| 9 |
How to reduce AFP levels? |
Iron reduction therapy by phlebotomy alone or in combination with a low-iron diet is an inexpensive treatment with few side effects and may reduce the risk of hepatocarcinogenesis associated with HCV [18]. A few studies have shown that phlebotomy can reduce serum AFP levels in patients with chronic hepatitis C. |
| 10 |
Is liver cancer curable? |
In general, cancers that are caught at an early stage are easiest to treat and have the best outcomes. Often, early-stage liver cancer can be cured. |
| 11 |
What is the marker for liver cancer? |
Alpha-fetoprotein (AFP) is the most widely used tumor marker for detecting liver cancer. However, other cancers and certain conditions, including pregnancy, hepatitis, and other types of cancer, may also increase AFP levels. Specific tumor markers that may lead to early detection of liver cancer are being studied. |
| 12 |
What is the purpose of the alpha fetoprotein test? |
The alpha fetoprotein test (AFP) is a blood test performed to measure, diagnose, or monitor fetal distress or fetal abnormalities. It can also detect some liver disorders and some cancers in adults. |
| 13 |
Can infection cause high AFP? |
Among 54 patients with a clinically and serologically verified cytomegalovirus infection, 8 (15%) had raised alpha-fetoprotein (AFP) levels in sera taken after the onset of infection. |
| 14 |
What causes abnormal AFP results? |
Lower than usual AFP levels may indicate that the fetus has a genetic disorder such as Down syndrome. It's important to understand that irregular AFP levels don't automatically mean the fetus has a genetic condition or a neural tube defect. Irregular AFP levels can also mean: You are having multiples, such as twins |
| 15 |
What level of AFP indicates cirrhosis? |
An increase in AFP levels (between 10 and 500 ng/ml, and sometimes up to 1000 ng/ml) can be seen in adult patients with hepatitis or cirrhosis with any etiology. Also, the frequency of elevated AFP levels (> 10 ng/mL) was reported in 20% of cases of chronic hepatitis and 40% of cases of cirrhosis. |
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