Human chorionic gonadotropin (hCG) is a hormone, produced by the rising
placenta shortly after the conception and secreted into the urine. The being pregnant
verify incorporates antibodies which notably react with this hormone.
The capillary movement carries the specimen to migrate alongside the membrane. When hCG contained within the sample reaches the Research Zone home of the membrane, it might selection a colored line. The absence of this colored line suggests a dangerous finish end finish consequence.
To hold out a course of administration, a colored line will appear on the administration zone home, if the verify has been carried out appropriately.
One Step Speedy Check equipment
SUMMARY AND EXPLANATION
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced in
being pregnant that is made by the rising embryo after conception and later by the syncytiotrophoblast. In frequent being pregnant, hCG could also be detected in urine as early as 1-2 weeks after conception. hCG ranges proceed to rise in a short time, often exceeding 100 mIU/mL by the first missed menstrual interval, and peaking contained within the 100,000-200,000 mIU/mL differ about 10-12 weeks into being pregnant. Early being pregnant testing, on all of the, is set by the detection or measurement of hCG. The Readability Being pregnant One Step Quick Research makes use of a combination of monoclonal and polyclonal antibodies to selectively detect elevated ranges of hCG in urine. Optimistic specimens react with the exact antibody-hCG-colored conjugate to selection a colored line on the verify line home of the membrane. Absence of this colored line suggests a dangerous finish end finish consequence. On the diploma of claimed sensitivity, the Readability Being pregnant One Step Quick Research exhibits no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at extreme physiological ranges.
INTENDED USE
The Readability Being pregnant One Step Quick Research (Cassette) is an in vitro diagnostic seen qualitative immunochromatographic assay designed for the quick dedication of human chorionic gonadotropin (hCG) in urine to assist contained within the detection of being pregnant. For expert use and OTC self verify use.
MATERIALS SUPPLIED
1. One Being pregnant Research pouch, containing a cassette, dropper, and desiccant. The
desiccant is for storage capabilities solely and is not used contained within the verify procedures.
2. Instructions for use.
REAGENTS
Coated Antibodies: Administration home: Goat anti-mouse (IgG) polyclonal antibody
Research home: Mouse monoclonal anti-hCG antibody
A Labeled Antibodies: The colloidal gold conjugate of monoclonal anti-hCG antibody B
WARNINGS AND PRECAUTIONS
1. This verify is designed for “in vitro diagnostic” use.
2. Study instructions fastidiously forward of using this verify.
3. This devices is for exterior use solely. Do not swallow.
4. Do not use the verify devices earlier the expiration date.
5. Do not use the devices if the pouch is punctured or won’t be accurately sealed.
6. Protect out of the attain of children.
7. Urine specimens will be infectious; Insure relevant handing and discard all used
devices consistent with native licensed pointers.
8. The verify is for single use solely. Do not reuse it.
COLLECTION AND STORAGE OF SPECIMENS
Any urine specimen is appropriate for being pregnant testing nonetheless the primary morning urine specimen is correct attributable to its highest focus of HCG. Urine should be collected in a transparent container earlier to testing.
READING TEST RESULTS
Optimistic (Pregnant）
Two distinct purple strains appear. One line should be contained within the administration home (C) and one completely completely different line should be contained within the verify home (T). This suggests you is possibly possibly pregnant. Detrimental (Not pregnant) One purple line appears contained within the administration home (C).No apparent purple or pink line appears contained within the verify home (T).This suggests you is possibly possibly not pregnant. Invalid The result is invalid if no purple line appears contained within the administration home (C), even when a line appears contained within the verify home (T). It is advisable to repeat the verify with a model new strip.
NOTE: if the verify line is weak, it’s strongly truly helpful that the verify be repeated in 48 hours. QUALITY CONTROL
Inside procedural controls are included contained within the verify. A colored band exhibiting contained within the administration home (C) is taken into account an inside optimistic procedural administration, confirming sufficient specimen amount and correct procedural technique. Exterior controls won’t be going to be geared up with this devices. It’s strongly truly helpful that optimistic and damaging controls be examined as an outstanding laboratory observe to confirm the verify course of and to substantiate relevant verify effectivity.
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