One Step Diagnostic

One Step Diagnostic Rapid Test Cassette

INTENDED USE

The Readability Being pregnant One Step Quick Test (Cassette) is an in vitro diagnostic seen qualitative immunochromatographic assay designed for the quick dedication of human chorionic gonadotropin (hCG) in urine to assist throughout the detection of being pregnant. For expert use and OTC self examine use.

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 common 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, usually exceeding 100 mIU/mL by the first missed menstrual interval, and peaking throughout the 100,000-200,000 mIU/mL range about 10-12 weeks into being pregnant. Early being pregnant testing, on the entire, depends on the detection or measurement of hCG. The Readability Being pregnant One Step Quick Test makes use of a mix 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 sort a colored line on the examine line space of the membrane. Absence of this colored line suggests a harmful finish end result. On the diploma of claimed sensitivity, the Readability Being pregnant One Step Quick Test reveals no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at extreme physiological ranges.

PRINCIPLE OF THE TEST
Human chorionic gonadotropin (hCG) is a hormone, produced by the rising
placenta shortly after the conception and secreted into the urine. The being pregnant
examine incorporates antibodies which significantly react with this hormone.
The capillary movement carries the specimen to migrate alongside the membrane. When hCG throughout the sample reaches the Test Zone space of the membrane, it will sort a colored line. The absence of this colored line suggests a harmful finish end result.
To perform a course of administration, a colored line will appear on the administration zone space, if the examine has been carried out accurately.

One Step Rapid Test kit
One Step Fast Take a look at equipment

MATERIALS SUPPLIED
1. One Being pregnant Test pouch, containing a cassette, dropper, and desiccant. The
desiccant is for storage capabilities solely and is not used throughout the examine procedures.
2. Instructions for use.

REAGENTS
Coated Antibodies: Administration space: Goat anti-mouse (IgG) polyclonal antibody
Test space: Mouse monoclonal anti-hCG antibody
A Labeled Antibodies: The colloidal gold conjugate of monoclonal anti-hCG antibody B

WARNINGS AND PRECAUTIONS
1. This examine is designed for “in vitro diagnostic” use.
2. Study instructions fastidiously sooner than using this examine.
3. This tools is for exterior use solely. Do not swallow.
4. Do not use the examine tools previous the expiration date.
5. Do not use the tools if the pouch is punctured or is not properly sealed.
6. Protect out of the attain of youngsters.
7. Urine specimens may be infectious; Insure appropriate handing and discard all used
devices consistent with native legal guidelines.
8. The examine is for single use solely. Do not reuse it.

COLLECTION AND STORAGE OF SPECIMENS
Any urine specimen is appropriate for being pregnant testing nevertheless the primary morning urine specimen is ideal on account of 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 throughout the administration space (C) and one different line should be throughout the examine space (T). This means you may be most likely pregnant. Detrimental (Not pregnant) One purple line appears throughout the administration space (C).No apparent purple or pink line appears throughout the examine space (T).This means you may be most likely not pregnant. Invalid The result is invalid if no purple line appears throughout the administration space (C), even when a line appears throughout the examine space (T). That you must repeat the examine with a model new strip.

NOTE: if the examine line is weak, it’s strongly beneficial that the examine be repeated in 48 hours.
QUALITY CONTROL
Inside procedural controls are included throughout the examine. A colored band displaying throughout the administration space (C) is taken into consideration an interior optimistic procedural administration, confirming satisfactory specimen amount and correct procedural technique. Exterior controls won’t be outfitted with this tools. It’s strongly beneficial that optimistic and damaging controls be examined as an excellent laboratory comply with to confirm the examine course of and to verify appropriate examine effectivity.

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