A rapid test for measuring Alpha-Fetoprotein (AFP) in whole blood /serum /plasma with the use of Novatrend ^TMfluorescence Immunoassay Analyzer. For professional in vitro diagnostic use only.

Application:

The AFP Test Cassette (Serum/Plasma) is based on Fluorescence immunoassay for the quantitative detection of Alpha-Fetoprotein in serum or plasma.

Description:

Alpha-Fetoprotein (AFP) is normally produced during fetal and neonatal development by the liver, yolk sac and in small concentrations by the gastrointestinal tract. By the second year of life, AFP concentrations decrease rapidly, and thereafter only trace amounts are normally detected in serum.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.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.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.

How to use?

Refer to Novatrend ^TM 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 Novatrend ^TM Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of Novatrend ^TM 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 Novatrend ^TM Fluorescence Immunoassay Analyzer.

The result of test for AFP is calculated by Novatrend ^TM Fluorescence Immunoassay Analyzer and display

the result on the screen. For additional information, please refer to the user manual of Novatrend ^TMFluorescence Immunoassay Analyzer.

Linearity range of FluroLit TM AFP is 5-400 ng/mL.

Reference range: ＜20 ng/mL.

Catalogue Number	Item Name	Sample	Test Range	KIT size
FI-AFP-302	AFP Test Cassette	S/P	5~400 ng/mL	10T/25T

Tag:

Place of Origin:	CHINA
Brand Name:	Fiatest
Certification:	CE, ISO13485
Model Number:	FI-AFP-302

Minimum Order Quantity:	500
Packaging Details:	40T/kit
Supply Ability:	100 Million a year

Format:	Cassette	Specimen:	Serum /Plasma
Kit Size:	10T/25T	Cut-Off:	5~400 Ng/mL
Certificate:	CE	Storage:	2-30°C
Highlight:	rapid diagnostic test kits , One Step Rapid Test

	Hangzhou AllTest Biotech CO.,LTD
	#383, Qiaoxin Road, Xiasha Street, Qiantang Disctrict, Hangzhou, Zhejiang, P.R.China
	86-571-56267891
	selina.wu@alltests.com.cn

Alpha-Fetoprotein (AFP) Diagnostic Test kit Use By Fiatest fluorescence Immunoassay Analyzer In Human serum /plasma

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