Payment & Shipping Terms:
|Category:||Home Test Kit||Format:||Home Kits|
|Specimen:||Whole Blood/Serum/Plasma||Testing Time:||5-15 Minutes|
|Shelf Life:||24 Months||Application:||Alpha-protein Home Use|
High accuracy Tumor Mark AFP Home Testing kits, individual private package, detecting Alpha-protein in serum
Product Name: AFP Home Testing kits
The AFP Rapid Test Cassette (Whole Blood /Serum /Plasma) is a rapid chromatographic immunoassay for the qualitative detection of AFP in whole blood, serum or plasma to aid in the diagnosis of Hepatocellular Carcinoma or fetal open neural tube defects.
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 The AFP Rapid Test Cassette (Whole Blood /Serum /Plasma) utilizes a combination of anti-AFP antibody coated particles and anti-AFP antibodies to detect elevated levels of AFP in whole blood, serum or plasma. The minimum detection level is 10ng/ml.
Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch or label of the closed canister. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
INTERPRETATION OF RESULTS
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Sensitivity and Specificity
The AFP Rapid Test Cassette (Whole Blood /Serum /Plasma) has correctly identified a panel of specimens and has been compared to a leading commercial AFP EIA test using clinical specimens. The results show that the relative sensitivity of the AFP Rapid Test Cassette (Whole Blood /Serum /Plasma) is 99.4%, and the relative specificity is 99.0%.
|AFP Rapid Test Cassette||Results||Positive||Negative|
Relative Sensitivity: 99.4% (95%CI*: 97.8%-99.9%) * Confidence Interval
Relative Specificity: 99.0% (95%CI*: 97.7%-99.7%)
Accuracy: 99.2% (95%CI*: 98.3%-99.7%)
|ORIENT NEW LIFE MEDICAL CO., LTD.|
|Email:||Jerry @ newlifebiotest .com|
Contact Person: Jerry Meng