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Serum Home Testing Kits Tumor Mark AFP Detecting Alpha Protein 10ng Cut - Off

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Serum Home Testing Kits Tumor Mark AFP Detecting Alpha Protein 10ng Cut - Off

China Serum Home Testing Kits Tumor Mark AFP Detecting Alpha Protein 10ng Cut - Off supplier
Serum Home Testing Kits Tumor Mark AFP Detecting Alpha Protein 10ng Cut - Off supplier Serum Home Testing Kits Tumor Mark AFP Detecting Alpha Protein 10ng Cut - Off supplier

Large Image :  Serum Home Testing Kits Tumor Mark AFP Detecting Alpha Protein 10ng Cut - Off

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,CE
Model Number: Cassette

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Price: USD0.5-USD2
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 2000000pcs/month
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Detailed Product Description
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
Cut-off: 10ng

High accuracy Tumor Mark AFP Home Testing kits, individual private package, detecting Alpha-protein in serum

 

 

Product Name: AFP Home Testing kits

 

 

Intended Use:

 

 

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.

 

 

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 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.

 

 

Storage:

 

 

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.

 

Serum Home Testing Kits Tumor Mark AFP Detecting Alpha Protein 10ng Cut - Off

 

LIMITATION

 

  1. The AFP Rapid Test Cassette (Whole Blood /Serum /Plasma) is for in vitro diagnostic use only. The test should be used for the detection of AFP in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in AFP concentration can be determined by this qualitative test.
  2. The AFP Rapid Test Cassette (Whole Blood /Serum /Plasma) will only indicate the presence of AFP in the specimen and should not be used as the sole criteria for the diagnosis of Hepatocellular Carcinoma or fetal open neural tube defects.
  3. The AFP Rapid Test Cassette (Whole Blood /Serum /Plasma) cannot detect less than 10ng/ml of AFP in specimens. A negative result at any time does not preclude the possibility of Hepatocellular Carcinoma or fetal open neural tube defects.
  4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
  5. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Hepatocellular Carcinoma or fetal open neural tube defects.

 

PERFORMANCE CHARACTERS:

 

 

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%.

 

Method EIA Total Results
AFP Rapid Test Cassette Results Positive Negative
Positive 317 5 322
Negative 2 503 505
Total Results 319 508 827

 

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.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry

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