Factory Fresh: Diagnostic Kit For Calprotectin Colloidal Gold

Diagnostic Kit For Calprotectin

Colloidal Gold

Production information

Model Number	CAL	Packing	25 Tests/ kit, 30kits/CTN
Name	Diagnostic Kit For Calprotectin	Instrument classification	Class I
Features	High sensitivity, Easy opeation	Certificate	CE/ ISO13485
Accuracy	> 99%	Shelf life	Two Years
Methodology	Colloidal Gold	OEM/ODM service	Avaliable

Summary Cal is a heterodimer, which is composed of MRP 8 and MRP 14. 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. The kit is a simple, visual semiqualitative test that detects cal in human faeces, it has high detection sensitivity and strong specificity. The test based on high specificit double antibodies sandwich reaction principle and gold immunochromatographic assay analysis technics, it can give a result within 15 minutes.Intend Use Diagnostic Kit for Calprotectin(cal) is is a colloidal gold immunochromatographic assay for the semiquantitative determination of cal from human faeces, which has important accessory diagnostic value for inflammatory bowel disease. This test is a screening reagent. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only. Meanwhile, this test is used for IVD, extra instruments are not needed.

The WIZ BIOTECH reagent test will be compared with the control reagent:

Test result of wiz	Test result of reference reagents			Positive coincidence rate:99.03%(95%C.I.94.70%~99.83%) Negative coincidence rate:100%(95%C.I.97.99%~100%) Total compliance rate: 99.68%(95%C.I.98.2%~99.94%)
Test result of wiz	Positive	Negative	Total
Positive	122	0	122
Negative	1	187	188
Total	123	187	310

Test procedure

1	Take out the sampling stick, inserted into the faeces sample, then put the sampling stick back, screw tight and shake well, repeat the action 3 times. Or using the sampling stick picked about 50mg faeces sample, and put in a faeces sample tube containing sample dilution, and screw tightly.
2	Use disposable pipette sampling take the thinner faeces sample from the diarrhea patient, then add 3 drops (about 100uL) to the fecal sampling tube and shake well, put aside.
3	Take out the test card from the foil bag, put it on the level table and mark it.
4	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, start timing.
5	The result should be read within 10-15 minutes, and it is invalid after 15 minutes.