INTENDED USE
The Readability Being pregnant One Step Speedy Take a look at (Cassette) is an in vitro diagnostic
visible qualitative immunochromatographic assay designed for the speedy
willpower of human chorionic gonadotropin (hCG) in urine to assist within the
detection of being pregnant. For skilled use and OTC self take a look at 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 might 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, is predicated on the detection or measurement of hCG.
The Readability Being pregnant One Step Speedy Take a look at 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 kind a coloured line on the take a look at line area of the membrane. Absence of this coloured line suggests a unfavorable consequence. On the degree of claimed sensitivity, the Readability Being pregnant One Step Speedy Take a look at reveals 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
take a look at accommodates antibodies which particularly react with this hormone.
The capillary motion carries the specimen emigrate alongside the membrane. When hCG within the pattern reaches the Take a look at Zone area of the membrane, it would kind a coloured line. The absence of this coloured line suggests a unfavorable consequence.
To function a process management, a coloured line will seem on the management zone area, if the take a look at has been carried out correctly.
One Step Speedy Take a look at equipment
MATERIALS SUPPLIED
1. One Being pregnant Take a look at pouch, containing a cassette, dropper, and desiccant. The
desiccant is for storage functions solely and isn’t used within the take a look at procedures.
2. Directions to be used.
REAGENTS
Coated Antibodies: Management area: Goat anti-mouse (IgG) polyclonal antibody
Take a look at area: Mouse monoclonal anti-hCG antibody
A Labeled Antibodies: The colloidal gold conjugate of monoclonal anti-hCG antibody B
WARNINGS AND PRECAUTIONS
1. This take a look at is designed for “in vitro diagnostic” use.
2. Learn directions rigorously earlier than utilizing this take a look at.
3. This equipment is for exterior use solely. Don’t swallow.
4. Don’t use the take a look at equipment past the expiration date.
5. Don’t use the equipment if the pouch is punctured or shouldn’t be properly sealed.
6. Maintain out of the attain of youngsters.
7. Urine specimens could also be infectious; Insure correct handing and discard all used
gadgets in keeping with native rules.
8. The take a look at is for single use solely. Don’t reuse it.
COLLECTION AND STORAGE OF SPECIMENS
Any urine specimen is acceptable for being pregnant testing however the first morning urine specimen is perfect due to its highest focus of HCG. Urine must be collected in a clear container previous to testing.
READING TEST RESULTS
Constructive (Pregnant）
Two distinct pink traces seem. One line must be within the management area (C) and
one other line must be within the take a look at area (T). This implies you’re most likely pregnant. Detrimental (Not pregnant) One pink line seems within the management area (C).No obvious pink or pink line seems within the take a look at area (T).This implies you’re most likely not pregnant.
Invalid The result’s invalid if no pink line seems within the management area (C), even when a line seems within the take a look at area (T). You must repeat the take a look at with a brand new strip.
NOTE: if the take a look at line is weak, it is suggested that the take a look at be repeated in 48
hours. QUALITY CONTROL
Inside procedural controls are included within the take a look at. A coloured band showing within the management area (C) is taken into account an inside optimistic procedural management, confirming ample specimen quantity and proper procedural approach.
Exterior controls should not equipped with this equipment. It’s endorsed that optimistic and unfavorable controls be examined as laboratory observe to verify the take a look at
process and to confirm correct take a look at efficiency.
Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.
