products details

Home Products

AFP CLIA Automatic Chemiluminescence Immunoassay Analyzer

Name: AFP CLIA Automatic Chemiluminescence Immunoassay Analyzer
Brand: Hangzhou AllTest Biotech CO.,LTD
SKU: CI-AFP
Price: Negotiable USD
Availability: InStock

Brand Name:	Unveil
Model Number:	CI-AFP
MOQ:	N/A
Price:	negotiation
Supply Ability:	10 M tests/month

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

Product Name:

Alpha-fetoprotein (AFP) Test Kit (CLIA) Automatic Chemiluminescence Immunoassay Analyzer

Cat No.:

CI-AFP

Principle:

Double Antibody Sandwich Method

Specimen:

S/P

Pack:

40T

Shelf Life:

2 Years

Format:

Strip

Certificate:

Storage Temperature:

2-8℃

Cut-Off:

2-1000 IU/mL

Packaging Details:

40T

Supply Ability:

10 M tests/month

Highlight:

CLIA Chemiluminescence Immunoassay Analyzer

Automatic Chemiluminescence Immunoassay Analyzer

AFP Chemiluminescence Immunoassay Analyzer

Product Description

Alpha-fetoprotein (AFP) Test Kit (CLIA) Automatic Chemiluminescence Immunoassay Analyzer

Product Name:	Alpha-fetoprotein (AFP) Test Kit (CLIA) Automatic Chemiluminescence Immunoassay Analyzer
Principle:	Double Antibody Sandwich Method
Pack:	40T
Format:	Strip
Storage Temperature:	2-8℃
Cat No.:	CI-AFP
Specimen:	S/P
Shelf Life:	2 Years
Certificate:	CE
Cut-Off:	2-1000 IU/mL

A CLIA test kit for the quantitative determination of Alpha-fetoprotein (AFP) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.

【INTENDED USE】

The Alpha-fetoprotein (AFP) Test Kit (CLIA) is intended for quantitative determination of Alpha-fetoprotein (AFP) in human serum and plasma, used as a serum marker of primary liver cancer for the diagnosis and efficacy monitoring of primary liver cancer clinically. For professional in vitro diagnostic use only.

【SUMMARY】

Alpha-fetoprotein is an embryo-specific alpha globulin and a single-polypeptide chain glycoprotein. It belongs to the albumin family and has a molecular weight of approximately 70,000 Daltons. AFP and albumin together constitute the main protein in the fetal circulation, and its synthesis mainly occurs in the liver and yolk sac of the fetus.1 It is secreted into fetal serum, reaching a peak around 13 weeks of gestation, and then gradually decreasing. When the fetus is 2 years old, only a small amount of AFP can be detected normally. If the level of AFP rises, it may appear in certain malignant diseases or pregnant adults. Studies have shown that in the serum of patients with primary liver cancer and non-spermocyte testicular cancer, the level of AFP will increase.

Changes in AFP levels are helpful for the diagnosis of patients with non-spermatogonial testicular cancer. For example, the combined detection of AFP and human chorionic gonadotropin (HCG) has been used as an important indicator for monitoring the condition of patients with non-spermogenic testicular cancer. 3-5 However, it is not recommended to use AFP for cancer screening in the general population.

In addition, the increase in AFP levels is also related to chronic viral hepatitis, liver cirrhosis and other malignant diseases.

【PRINCIPLE】

This product uses the double antibody sandwich method. In the first step, the sample, the AFP antibody labeled with alkaline phosphatase, and the magnetic particles coated with the AFP antibody are mixed. After incubation, the AFP in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies. The third step is to add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of AFP in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of AFP in the sample.

【REAGENTS】

The reagent strip includes AFP antibody coated with magnetic particles, alkaline phosphatase labeled AFP antibody, wash buffer and substrate

solution.

【SPECIMEN COLLECTION AND PREPARATION】

Collect and handle the specimen strictly as below:

1. Collect the specimen according to standard procedures.

2. Human serum collected using standard sampling tubes or tubes containing separating gel.

3. Human plasma collected using EDTA or Heparin sodium.

4. Separate human serum and plasma from blood as soon as possible to avoid hemolysis. Grossly hemolytic, lipidic or turbid samples should not

be used. Specimen with extensive particulate should be clarified by centrifugation prior to use. Do not use specimens with fibrin particles or contaminated with microbial growth.

5. 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,

below -20 °C stable for 3 months.

6. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing.

Specimens should not be frozen and thawed repeatedly.

7. If the patients had been treated by high dose of biotin (5 mg/day), blood collection must be done after at least 8 hours.

8. If specimens are to be shipped, pack them in compliance with local regulations covering the transportation of etiologic agents

【DIRECTIONS FOR USE】

Refer to Automatic Chemiluminescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the analyzer.

1. Preparation

1) Take the test kit from the refrigerated environment and use it after equilibrating to room temperature.

2) Input reagent information

Before using a new batch of reagents, the reagent information should be entered.

Run the analyzer software, enter the adding reagent interface and scan the reagent information QR code in the information card to input the test information.

2. Calibration

1) When using a new batch of reagents, calibration must be priority performed after the reagent information is entered.

2) The system requires double parallel tests calibrator 1 and calibrator 2 and will assign 2 test slots to calibrator 1 and calibrator 2 respectively by default and the four tests should be done in one time.

Follow calibration procedures according to the user manual of the analyzer.

Load the reagent strips, then add 100-150 μL of corresponding calibrator 1 and 2 to the corresponding sample well of the reagent strips,finally tap the start button to perform the calibration tests.

3) Calibration frequency:

Once a calibration is accepted and stored, all subsequent samples may be tested without further calibration unless:

A reagent kit with a new lot number is used.

Reagents of the same batch number have been used for more than 4 weeks. As required: For example, controls testing are out of range

Tags:

Custom Monoclonal Antibody

Drug Abuse Test Kit

Rapid Test Kit

Infectious Disease Testing

Accuate Cardiac Marker Rapid Test kits

Convenient Oncology Rapid Diagnostic Test kits

Rapid Diagnostic Test Kits

Fluorescence Immunoassay Analyzer

Glucose Monitoring Device

Veterinary Rapid Test Kits

Flourescence Immunoassay Test Kits

Urine Chemistry Analyzer

Nucleic Acid PCR

Rapid Test Reader

Chemiluminescence Immunoassay Test

Custom Monoclonal Antibody

Drug Abuse Test Kit

Rapid Test Kit

Infectious Disease Testing

Accuate Cardiac Marker Rapid Test kits

Convenient Oncology Rapid Diagnostic Test kits

Rapid Diagnostic Test Kits

Fluorescence Immunoassay Analyzer

Glucose Monitoring Device

Veterinary Rapid Test Kits

Flourescence Immunoassay Test Kits

Urine Chemistry Analyzer

Nucleic Acid PCR

Rapid Test Reader

Chemiluminescence Immunoassay Test

products details

AFP CLIA Automatic Chemiluminescence Immunoassay Analyzer

AFP CLIA Automatic Chemiluminescence Immunoassay Analyzer

CLIA Chemiluminescence Immunoassay Analyzer

Automatic Chemiluminescence Immunoassay Analyzer

AFP Chemiluminescence Immunoassay Analyzer