Manufacturer of Follicle Stimulating Rapid Test Kit - Pepsinogen I Pepsinogen II and Gastrin-17 Combo rapid test kit – Baysen

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Manufacturer of Follicle Stimulating Rapid Test Kit - Pepsinogen I Pepsinogen II and Gastrin-17 Combo rapid test kit – Baysen Detail:

Diagnostic Kit for Pepsinogen I/Pepsinogen II /Gastrin-17

Methodology:fluorescence immunochromatographic assay

Production information

Model Number	G17/PGI/PGII	Packing	25 Tests/ kit, 30kits/CTN
Name	Diagnostic Kit for Pepsinogen I/Pepsinogen II /Gastrin-17	Instrument classification	Class II
Features	High sensitivity, Easy opeation	Certificate	CE/ ISO13485
Accuracy	> 99%	Shelf life	Two Years
Methodology	fluorescence immunochromatographic assay	OEM/ODM service	Avaliable

INTENDED USE

This kit is applicable to the in vitro quantitative detection of concentration of Pepsinogen I (PGI), Pepsinogen II
(PGII) and Gastrin 17 in human serum/plasma/whole blood samples, to evaluate gastric oxyntic gland cell
function, gastric fundus mucosa lesion and atrophic gastritis. The kit only provides test result of Pepsinogen I
(PGI), Pepsinogen II (PGII) and Gastrin 17. The obtained result shall be analyzed in combination with other clinical
information. It must only be used by healthcare professionals.

Test procedure

1	Before using the reagent,read the package insert carefully and familiarize yourself with the operating procedures.
2	Select standard test mode of WIZ-A101 portable immune analyzer.
3	Open the aluminum foil bag package of reagent and take out the test device.
4	Horizontally insert the test device into the slot of immune analyzer.
5	On home page of operation interface of immune analyzer, click “Standard” to enter test interface
6	Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument and select sample type. Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step.
7	Check the consistency of “Product Name”, “Batch Number” etc. On test interface with information on the kit label.
8	After information consistency is confirmed, take out sample diluents, add 80µL of serum/plasma/whole blood sample, and sufficiently mix.
9	Add 80µL of above mixed solution into the sample hole of test device.
10	After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface.
11	Immune analyzer will automatically complete test and analysis when test time is reached.
12	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.

Superiority

The kit is high accurate,fast and can be transported at room temperature.It’s easy to operate,the mobile phone app can assist in the interpretation of results and save them for easy follow-up.

Specimen type : serum/plasma/whole blood samples

Testing time:10-15mins

Storage:2-30℃/36-86℉

Methodology:Solid Phase

Feature:

• High sensitive

• result reading in 15 minutes

• Easy operation

• 2 tests in one time

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The Clinical Performance

Clinical evaluation performance of the product is assessed by collecting 200 clinical samples. Use the marketed kit of enzyme linked immunosorbent assay as the control reagent. Compare the PGI test results. Use linearity regression to investigate their comparability. Correlation coefficients of two tests are y = 0.964X + 10.382 and R=0.9763 respectively. Compare the PGII test results. Use linearity regression to investigate their comparability. Correlation coefficients of two tests are y = 1.002X + 0.025 and R=0.9848 respectively. Compare the G-17 test results. Use linearity regression to investigate their comparability. Correlation coefficients of two tests are y =0.983X + 0.079 and R=0.9864 respectively.

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