Diagnostic Kit for Calprotectin(Fluorescence Immunochromatographic Assay)
For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE
Diagnostic Kit for Calprotectin(Cal) is suitable for the quantitative determination of human faeces Cal by fluorescence immunochromatographic assay, which has important accessory diagnostic value for inflammatory bowel disease.All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY
Cal is a heterodimer, which is composed of MRP 8 and MRP 14^[1]. It exists in neutrophils cytoplasm and expressed on mononuclear cell membranes. Cal is acute phase proteins, it has a well stable phase about one week in human faeces, it is determined to be a inflammatory bowel disease marker^[2-3]. The kit is a simple, visual quantitative test that detects Cal in human faeces, it has high detection sensitivity and strong specificity. The test based on high specificit of double antibodies sandwich reaction principle and fluorescence immunochromatographic assay analysis technics, which can give a result within 15 minutes.

PRINCIPLE OF THE PROCEDURE
The strip has anti-Cal coating antibody on test region, which is fastened to membrane chromatography in advance. Lable pad is coated by fluorescence labeled anti-Cal antibody in advance. When testing positive sample, the Cal in sample can be mixed with fluorescence labeled anti-Cal antibody, and form immune mixture. As the mixture is allowed to migrate along the test strip, the Cal conjugate complex is captured by anti-Cal coating antibody on the membrane and forms complex. The fluorescence intensity is positively correlated with the Cal content. The Cal in sample can be detected by fluorescence immunoassay analyzer.

REAGENTS AND MATERIALS SUPPLIED

25T package components：
Test card individually foil pouched with a desiccant 25T
Sample diluents 25T
Package insert 1

MATERIALS REQUIRED BUT NOT PROVIDED
Sample collection container,timer

SAMPLE COLLECTION AND STORAGE
1.Use a disposable clean container to collect fresh faeces sample, and tested immediately. If can not be tested immediately, please stored at 2-8°C for 3 days or below -15°C for 6 months.
2.Take out the sampling stick, inserted into the faeces sample,repeat the action 3 times, take the different parts of the faeces sample each time, then put the sampling stick back, screw tight and shake well, Or using the sampling stick picked about 50mg faeces sample, and put in a faeces sample tube containing sample dilution, and screw tightly.
3.Use disposable pipette sampling take the faeces sample from the diarrhea patient, then add 3 drops (about 100µL) to the fecal sampling tube and shake well.

Notes:
1.Avoid freeze-thaw cycles.
2.Thaw samples to room temperature before use.

ASSAY PROCEDURE

Please read the instrument operation manual and package insert before testing.
1.Lay aside all reagents and samples to room temperature.
2.Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.
3.Scan the dentification code to confirm the test item.
4.Take out the test card from the foil bag.
5.Insert the test card into the card slot, scan the QR code, and determine the test item.
6.Remove the cap from the sample tube and discard the first two drops diluted sample, add 3 drops (about 100uL) no bubble diluted sample verticaly and slowly into sample well of the card with provided dispette.
7.Click the “standard test” button, after 15 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.
8.Refer to the instruction of Portable Immune Analyzer(WIZ-A101).

EXPECTED VALUES
Cal <60μg/g
It is recommended that each laboratory establish its own normal range representing its patient population.

TEST RESULTS AND INTERPRETATION
1.The Cal in sample is more that 60μg/g, and should rule out the change of the physiological state. The results are indeed abnormal and should be diagnosed with clinical symptoms.
2.The results of this method are only applicable to the reference ranges established in this method, and there is no direct comparability with other methods.
3.Other factors can also cause errors in detection results, including technical reasons, operational errors and other sample factors.

STORAGE AND STABILITY
1.The kit is 18 months shelf-life from the date of manufacture. Store the unused kits at 2-30°C. DO NOT FREEZE. Do not use beyond the expiration date.
2.Do not open the sealed pouch until you are ready to perform a test, and the single-use test is suggested to be used under the required environment (temperature 2-35℃, humidity 40-90%) within 60 mins as quickly as possible.
3.Sample diluent is used immediately after being opened.

WARNINGS AND PRECAUTIONS
.The kit should be sealed and protected against moisture.
.All positive specimens shall be validated by other methodologies.
.All specimens shall be treated as potential pollutant.
.DO NOT use expired reagent.
.DO NOT interchange reagents among kits with different lot No..
.DO NOT reuse test cards and any disposable accessories.
.Misoperation, excessive or little sample can lead to result deviations.

LIMITATION
.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.
.This test result is only for clinical reference, should not serve as the only basis for clinical diagnosis and treatment, the patients clinical management should be comprehensive consideration combined with its symptoms, medical history, other laboratory examination, treatment response, epidemiology and other information.
.This reagent is only used for fecal tests. It may not obtain accurate result when used for other samples such as saliva and urine and etc.

PERFORMANCE CHARACTERISTICS

REFERENCES
1.Li,G.&Y.L.Li.The relationship between calcium and clinical disease[J].The Journal of Practical Medicine,2007,23(15)
2.Han,W.,Xu,J.M.,et al.The clinical study of calamine and lactoferrin in patients with ulcerative colitis[J].Chinese Journal of Gastroenterology,2010,15(4)
3.Wang,Z.H.,Guo,H.B.,et al.The study on the relationship between fecal calamine and inflammatory bowel disease[J]. Science Technology and Engineering,2010-03,10(8)

Key to symbols used:

	In Vitro Diagnostic Medical Device
	Manufacturer
	Store at 2-30℃
	Expiration Date
	Do Not Reuse
	CAUTION
	Consult Instructions For Use

Xiamen Wiz Biotech CO.,LTD
Address:3-4 Floor,NO.16 Building,Bio-medical Workshop,2030 Wengjiao West Road,Haicang District,361026,Xiamen,China
Tel:+86-592-6808278
Fax:+86-592-6808279