Immunoassay Fecal Occult Blood Diagnostic Reagent

Short Description:

Diagnostic Kit for Fecal Occult Blood

Methodology: Fluorescence Immunochromatographic Assay

Testing time: 15 minutes

Storage temperature: 2°C-30°C

Valid Time: 24 months

Accurancy: More than 99%

Specification: 25 test/box

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Product Detail

Product Tags

1. INTEDED USE

This kit is applicable to in vitro quantitative detection of hemoglobin in human stool sample, which’s used for evaluation of gastrointestinal bleeding. This kit only provides detection results of hemoglobin in stool sample, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.

2. PRODUCT SPECIFICATION

Model No.	FOB
Methodology	Fluorescence Immunochromatographic Assay
Sample Type	faeces
Time to Result	10-15mins
Storage	2~30 ℃/36~86℉
Shelf Life	24 months
Certificate	ISO13485,CE,MHRA

MAIN KIT COMPONENTS

* Test device

* Sample diluents

* Disposable pipette

* Instructions for Use

PACKING

* 25 test /kit

* Aluminum foil bag labeling

* shrink wrap

3.TEST METHOD

1	Please read the instructions carefully before use, and operate in strict accordance with the requirements of the instructions to ensure the accuracy of the results. Make sure balance the test device and specimen to room temperature (15°C~30°C) prior to test.
2	Ⅰ Select standard detection mode of Portable Immune Analyzer (WIZ-A101)
3	I-1: Use of portable immune analyzer
4	Open the reagent aluminum foil bag and take out the test card;
5	Insert the test card into the slot of Analyzer horizontally;
6	On the homepage of the operation interface on Analyzer, click "Standard" to enter the detection interface;
7	On the homepage of the operation interface on Analyzer, click "Standard" to enter the detection interface;
8	Click "QC scan" to scan the QR code inside the kit box and input the relevant parameters of the kit into the instrument; Note: each production batch number reagent should be scanned once. If this batch number has been scanned, this step can be omitted.
9	Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit marker.
10	Start to add sample in case of consistent information: Remove the cap of sampling tube, discard the first two drops of diluted sample, add 3 drops (approx. 100μL) of bubble-free diluted sample dropwise to well of test device vertically and slowly;
11	After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface.
12	Immune analyzer will automatically complete test and analysis when test time is reached.
13	Ⅰ-2: Result calculation and display After test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through “History” on home page of operation interface.

4.CLINICAL PERFORMANCE

linical performance of this product’s assessed through collection of 160 cases of clinical samples. Corresponding marketed kit of fluorescence immunochromatographic assays used as reference reagent, detection results have been compared and their comparability has been studied through linear regression, The correlation coefficients of the two tests were Y=0.980X+ 3.680 and R=0.9808, respectively.