One Step Diagnostic

One Step Diagnostic Rapid Test Cassette

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 comprises 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’s going to type a coloured line. The absence of this coloured line suggests a adverse consequence.
To function a process management, a coloured line will seem on the management zone area, if the check has been carried out correctly.

INTENDED USE

The Readability Being pregnant One Step Speedy Check (Cassette) is an in vitro diagnostic visible qualitative immunochromatographic assay designed for the fast willpower 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, basically, relies on the detection or measurement of hCG. The Readability Being pregnant One Step Speedy 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 adverse consequence. On the stage of claimed sensitivity, the Readability Being pregnant One Step Speedy Check reveals no cross-reactivity interference from the structurally associated glycoprotein hormones hFSH, hLH and hTSH at excessive physiological ranges.

One Step Rapid Test kit
One Step Speedy Check package

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 package is for exterior use solely. Don’t swallow.
4. Don’t use the check package past the expiration date.
5. Don’t use the package if the pouch is punctured or shouldn’t be effectively sealed.
6. Hold out of the attain of youngsters.
7. Urine specimens could also be infectious; Insure correct handing and discard all used
gadgets in accordance with native rules.
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 needs to be collected in a clear container previous to testing.

READING TEST RESULTS
Optimistic (Pregnant)
Two distinct crimson traces seem. One line needs to be within the management area (C) and one other line needs to be within the check area (T). This implies you’re most likely pregnant. Destructive (Not pregnant) One crimson line seems within the management area (C).No obvious crimson or pink line seems within the check area (T).This implies you’re most likely not pregnant. Invalid The result’s invalid if no crimson line seems within the management area (C), even when a line seems within the check area (T). It’s best 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
Inner procedural controls are included within the check. A coloured band showing within the management area (C) is taken into account an inside optimistic procedural management, confirming adequate specimen quantity and proper procedural method. Exterior controls usually are not provided with this package. It is strongly recommended that optimistic and adverse controls be examined as a great laboratory apply to verify the check process and to confirm correct check efficiency.

 

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