The β-hCG Test Cassette is intended for quantitative determination of β-human chorionic gonadotropin (β-hCG) in specimens as an aid in the diagnosis of pregnancy.
【SUMMARY】
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the
developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected
in both serum or plasma as early as 7 to 10 days after conception.1,2,3,4 It is heterodimeric,
with an α (alpha) subunit identical to that of luteinizing hormone (LH), follicle-stimulating
hormone (FSH), thyroid-stimulating hormone (TSH), and β (beta) subunit that is unique
to hCG. This procedure is employed to ensure that tests do not make false positives by
confusing hCG with LH and FSH. (The latter two are always present at varying levels in
the body, whereas the presence of hCG almost always indicates pregnancy.)
Human chorionic gonadotropin (hCG) is a hormone produced by the placenta after
implantation.5,6 The presence of hCG is detected in some pregnancy tests (HCG
pregnancy strip tests). Some cancerous tumors produce this hormone; therefore,
elevated levels measured when the patient is not pregnant may lead to a cancer
diagnosis and, if high enough, paraneoplastic syndromes, however, it is not known
whether this production is a contributing cause, or an effect of carcinogenesis. The
pituitary analog of hCG, known as luteinizing hormone (LH), is produced in the pituitary
gland of males and females of all ages.5,7 This tests employ a monoclonal antibody,
which is specific to the β-subunit of hCG (β-hCG).
The β-hCG Test cassette is a test that quantitatively detects the β-hCG level
in Whole Blood/Serum/Plasma specimen. The test utilizes a combination of antibodies
including a monoclonal anti-β-HCG antibody to selectively detect elevated levels of β-
hCG. The minimum detection level is 2mIU/mL.
【PRINCIPLE】
The β-hCG Test Cassette (Whole Blood/Serum/Plasma) is based on
Fluorescence Immunoassay for the detection of β-human chorionic gonadotropin in
Whole Blood,Serum or Plasma to evaluate the pregnant in women. The Specimen
moves from Specimen pad to absorbent pad. If the specimen contains β-hCG, it
attaches to the fluorescent microspheres-conjugated anti-β-hCG antibodies. Then the
complex will be captured by the capture antibodies coated on the nitrocellulose
membrane (Test line). The concentration of β-hCG in the Specimen correlates linearly
with the fluorescence signal intensity captured on the T line. According to the
fluorescence intensity of the test and standard curve, the concentration of β-hCG in the
Specimen can be calculated by Analyzer to show β-hCG concentration in specimen.
【REAGENTS】
The test contains anti-β-hCG antibody conjugated fluorophores and capture reagents
coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing such
as laboratory coats, disposable gloves and eye protection when specimens are
assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The β-hCG Test Cassette should only be used with the Analyzer by
approved medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do not
use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
1. Before performing the test, please make sure that all components are brought to room
temperature(15-30℃). Cold buffer solution or moisture condensation on the membrane
can lead to invalid test results.
2. Take a tube with buffer solution out of the kit. Document patients name or ID on it.
Specimen Handling
1. Collect the specimen according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Serum and plasma
specimens may be stored at 2-8°C for up to 1 day, for long term storage, specimens
should be kept below -20°C. Whole blood collected by venipuncture should be stored at
2-8°C if the test is to be used within 1 day of collection. Do not freeze whole blood
specimens.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing
of specimens.
4. EDTA K2, Heparin sodium, Citrate sodium and Oxalate potassium can be used as the
anticoagulant tube for collecting the blood specimen.
Specimen Dilution
1. The specimen (15μl of whole blood/serum/plasma) can be added directly with the
pipette into the buffer.
2. Close the tube and shake the specimen by hand for approximately 10 seconds so
specimen and dilution buffer mix well.
3. Let the diluted Specimen homogenize for approximately 1 minute.
4. It is best to place the diluted specimen on an ice pack and leave the specimen at room
