The Readability Being pregnant One Step Fast Check (Cassette) is an in vitro diagnostic visible qualitative immunochromatographic assay designed for the fast dedication of human chorionic gonadotropin (hCG) in urine to help within the detection of being pregnant. For skilled use and OTC self check use.
SUMMARY AND EXPLANATION
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced in
being pregnant that’s made by the growing embryo after conception and later by the syncytiotrophoblast. In regular being pregnant, hCG may be detected in urine as early as 1-2 weeks after conception. hCG ranges proceed to rise very quickly, often exceeding 100 mIU/mL by the primary missed menstrual interval, and peaking within the 100,000-200,000 mIU/mL vary about 10-12 weeks into being pregnant. Early being pregnant testing, on the whole, relies on the detection or measurement of hCG. The Readability Being pregnant One Step Fast Check makes use of a mixture of monoclonal and polyclonal antibodies to selectively detect elevated ranges of hCG in urine. Optimistic specimens react with the precise antibody-hCG-colored conjugate to type a coloured line on the check line area of the membrane. Absence of this coloured line suggests a damaging end result. On the degree of claimed sensitivity, the Readability Being pregnant One Step Fast Check exhibits no cross-reactivity interference from the structurally associated glycoprotein hormones hFSH, hLH and hTSH at excessive physiological ranges.
PRINCIPLE OF THE TEST
Human chorionic gonadotropin (hCG) is a hormone, produced by the growing
placenta shortly after the conception and secreted into the urine. The being pregnant
check incorporates antibodies which particularly react with this hormone.
The capillary motion carries the specimen emigrate alongside the membrane. When hCG within the pattern reaches the Check Zone area of the membrane, it would type a coloured line. The absence of this coloured line suggests a damaging end result.
To function a process management, a coloured line will seem on the management zone area, if the check has been carried out correctly.
One Step Fast Check equipment
MATERIALS SUPPLIED
1. One Being pregnant Check pouch, containing a cassette, dropper, and desiccant. The
desiccant is for storage functions solely and isn’t used within the check procedures.
2. Directions to be used.
REAGENTS
Coated Antibodies: Management area: Goat anti-mouse (IgG) polyclonal antibody
Check area: Mouse monoclonal anti-hCG antibody
A Labeled Antibodies: The colloidal gold conjugate of monoclonal anti-hCG antibody B
WARNINGS AND PRECAUTIONS
1. This check is designed for “in vitro diagnostic” use.
2. Learn directions fastidiously earlier than utilizing this check.
3. This equipment is for exterior use solely. Don’t swallow.
4. Don’t use the check equipment past the expiration date.
5. Don’t use the equipment if the pouch is punctured or isn’t nicely sealed.
6. Preserve out of the attain of kids.
7. Urine specimens could also be infectious; Insure correct handing and discard all used
gadgets in keeping with native laws.
8. The check is for single use solely. Don’t reuse it.
COLLECTION AND STORAGE OF SPECIMENS
Any urine specimen is suitable for being pregnant testing however the first morning urine specimen is perfect due to its highest focus of HCG. Urine ought to be collected in a clear container previous to testing.
READING TEST RESULTS
Optimistic (Pregnant）
Two distinct purple strains seem. One line ought to be within the management area (C) and one other line ought to be within the check area (T). This implies you might be in all probability pregnant. Detrimental (Not pregnant) One purple line seems within the management area (C).No obvious purple or pink line seems within the check area (T).This implies you might be in all probability not pregnant. Invalid The result’s invalid if no purple line seems within the management area (C), even when a line seems within the check area (T). You need to repeat the check with a brand new strip.
NOTE: if the check line is weak, it is strongly recommended that the check be repeated in 48 hours. QUALITY CONTROL
Inside procedural controls are included within the check. A coloured band showing within the management area (C) is taken into account an inner optimistic procedural management, confirming adequate specimen quantity and proper procedural method. Exterior controls will not be equipped with this equipment. It is strongly recommended that optimistic and damaging controls be examined as a very good laboratory follow to verify the check process and to confirm correct check efficiency.
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