intended use
Clarity Pregnancy One Step Rapid Test (Cassette) An In Vitro Diagnostic
Visual qualitative immunochromatographic assay called pregnancy
Of
Designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the detection. For commercial use and OTC self test use.
Summary and Explanation
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by
Pregnancy that is formed after conception by the developing embryo and later by syncytiotrophoblasts. In a normal pregnancy, hCG can be detected in urine 1-2 weeks after conception. HCG levels continue to rise very rapidly, usually exceeding 100 mIU/mL by the first missed menstrual period, and in the 100,000–200,000 mIU/mL range by approximately 10–12 weeks into pregnancy. Initial
A pregnancy test, in general, is based on the detection or measurement of hCG.
Monoclonal in Clarity Pregnancy One Step Rapid Test
and a combination of polyclonal antibodies are used to detect elevated levels of hCG in the urine.
Positive samples react with the specific antibody-hCG-colored conjugate to form a colored line in the test line region of the membrane. The absence of this colored line indicates a negative result. At the level of claimed sensitivity, the Clarity Pregnancy One Step Rapid Test shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
principle of testing
Human chorionic gonadotropin (hCG) is a hormone,
Which is produced by the developing placenta soon after conception and is secreted in the urine. pregnancy
The test contains antibodies that specifically react with this hormone.
Capillary action carries the sample to migrate along the membrane. When the hCG in the sample reaches the test zone area of the membrane, it will form a colored line. The absence of this colored line indicates a negative result.
To act as a process control, if the test has been done properly, a colored line will appear in the control area area.
material supplied
1. A pregnancy test pouch, which includes a cassette, dropper and desiccant.
The absorbent is for storage purposes only and is not used in testing procedures.
2. Instructions for use.
reagent
Coated Antibody: Control Region: Goat Anti-Mouse (IgG) Polyclonal Antibody
Test area: mouse monoclonal anti-hCG antibody
A labeled antibody: colloidal gold conjugated of monoclonal anti-hCG antibody B
warnings and precautions
1. This test is designed for “in vitro diagnostic” use.
2. Read the instructions carefully before using this test.
3. This kit is for outdoor use only. do not swallow.
4. Do not use the test kit after the expiration date.
5. Do not use the kit if the pouch has a hole or is not sealed properly.
6. Keep out of reach of children.
7. Urine samples may be infectious;
Insure proper handing over and discarding all used equipment in accordance with local regulations.
8. The test is for single use only. Do not reuse it.
one step diagnostic rapid test cassette
Collection and storage of samples Any urine sample is suitable for a pregnancy test but the first morning urine sample is optimal due to the highest concentration of hCG. Urine should be collected in a clean container prior to the test.
reading test results
positive (pregnant)
Two distinct red lines are visible. a line in the control area (C)
and the second line should be in the test region (T). This means that you are probably pregnant. Negative (not pregnant) a control region (C) shows a red line. No obvious red or pink lines appear in the test region (T). This means that you are probably not pregnant.
Invalid The result is invalid if no red line appears in the control region (C), even if a line appears in the test region (T). You should repeat the test with a new bandage.
Note: If the test line is weak, it is recommended that the test 48
To be repeated in hours.
quality control
Internal procedural controls are involved in testing. The colored bands visible in the control region (c) are considered to be internal positive procedural controls, confirming sufficient sample volume and correct procedural technique.
External controls are not supplied with this kit. It is recommended that the test
It is a good laboratory practice to test positive and negative controls to confirm the procedure and to verify proper test performance.
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.
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.
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