Malaysia Manufacturer CE Marked iCARE Chlamydia Test Kit for Home Use

Product Overview

Description

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Category Name	STD Rapid Test Kit
Catalog No	WF1001
Packing	Generic: 50T   OTC packing
Specimen	Whole blood / Serum / Plasma
Type of Test	Antigen
Format	Hospital version: 1 well cassette, pipette, diluents (4 bottles)   Field version: Buffer A, Buffer B, extraction tube, swab, 1 well cassette, pipette
Sample	10ul serum
Result	Within 5 minutes
Specificity	95%
Sensitivity	98%
Shelf Life	2 years from date of production
Storage	Store at 4 ºC ~ 30 ºC in the sealed pouch up to the expiration date.

iCARE One Step Chlamydia Rapid Screen Test (Swab/Urine) is a rapid immunoassay for direct qualitative detection of Chlamydia trachomatis antigen in endocervical or endourethral swab specimens.

iCARE One Step Chlamydia Rapid Screen Test (Swab/Urine) is a rapid immuno- chromatographic test for the visual detection of Chlamydia trachoma antigen in either endocervical swab specimens or urine specimens. This test adopts double antibody sandwich method. When add exactly four drops of specimen to the sample well, the specimen is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane.

When the Chlamydia trachoma antigen levels are at or above the target cutoff (the detection limit of the test), Chlamydia trachoma antigen in the specimen binds to the antibody-dye conjugate and are captured by monoclonal antibody immobilized in the Test region (T) of the device. This produces a colored test band and indicates a positive result.

When the Chlamydia trachoma antigen levels are zero or below the target cutoff, there is not a visible colored band in the Test region (T) of the device, which indicates a negative result.

To serve as a procedure control, a colored line will appear at the Control region (C), if the test has been performed properly.