PRINCIPLE

The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control region. During the test, urine specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence or absence of HCG. 

STORAGE

The kits should be stored at temperature 4-30° C in the sealed pouch for the duration of the shelf life. 

PRECAUTION

1. For in vitro diagnostic use only.
2. Do not use after expiration date.
3. Test device should remain sealed until use. 

REAGENTS AND MATERIALS PROVIDED

1. Rapid HCG Test Card
2. Disposable sample pipet
2. Instruction for use 

SPECIMENS COLLECTION

Plasma:

1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing or label and store it at 2-8° C for up to two weeks. Plasma may be frozen at -20° C for up to one year.

Serum:

1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store it at 2-8° C for up to two weeks. Serum may be frozen at -20° C for up to one year.

Urine:

1. The urine specimens must be collected in a clean dry container either plastic or glass without preservatives. No centrifugation or filtration of urine is required. Specimens collected at any time may be used. However the first morning urine generally contains the highest concentration of the hormone.
2. If specimens can not be tested within 3 days of collection, they should be stored refrigerated at 2-8 degree.

Pregnancy Test Kit Formats---Strips,Cassettes, and Midstreams

Pregnancy Test Strip

Very economical and easy to use. This type of Dip and Read test is designed for rapid qualitative diagnosis of hCG pregnancy hormone in urine. It is used all over the world, whether it is in professional setting or for home pregnancy testing. Simply dip the strip into a urine specimen and allow 5 minutes for development of results - control line (negative pregnancy test results) or control and test line (positive pregnancy test results). The pregnancy test strip comes individually packaged in a foil pouch with desiccant for moisture protection. The test pouch also has brief instructions and picture interpretations of the results. grf hcg test

Pregnancy Test Cassette

is mainly used by professionals and individuals who prefer to write data on the pregnancy test cassette (on a patient ID window). In this manner a user can eliminate confusion in a busy lab setting. Also individuals who like to monitor and keep track of pregnancy monitoring may choose this device over other formats. The pregnancy cassette has a plastic window that protects the testing region from moisture and other possible contaminants. The pregnancy test cassette comes individually packaged in a foil pouch with desiccant for moisture protection and a sterilized dropper for dispensing of the specimen. Simply put 3-4 drops of urine into a dropping well and allow 5 minutes for development of results - control line (negative results) or control and test line (positive results).grf hcg test

Pregnancy Test Midstream

is commonly used for home pregnancy testing, or you can keep it with you on the go. You can apply the pregnancy midstream directly into the urine stream so there is no need for urine collection. The hCG midstream has a removable cap for protective purposes - as well as the plastic window over the testing region. The pregnancy midstream test comes individually packaged in a foil pouch with desiccant for moisture protection. These types of pregnancy testing formats are sold in drugstores and pharmacies usually under different brand names.grf hcg test

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