β-hCG FIA Test

The human chorionic gonadotropin (β-hCG) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic immunofluorescent assay for the quantitative detection of β-hCG in human serum or plasma, with a detection sensitivity of 5.0 mIU/mL, using the RaFIA system. This test is intended for in vitro diagnostic use only.

hCG (human chorionic gonadotropin) is a glycoprotein hormone secreted by placental trophoblast cells. hCG maintains the level of corpus luteum and decreases the activity of mother lymphocytes, which prevent the embryo from immune rejection. hCG consists of an α subunit and a β subunit. The α subunit is identical to that of Thyroid-Stimulating Hormone (TSH), Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH), while the β subunit is specific for hCG. The concentration of β-hCG is therefore used to represent the concentration of hCG in human blood and used for early detection of pregnancy.

The β-hCG FIA Test was developed to detect circulating β-hCG in serum and plasma within 10 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

LIMITS AND RANGES:

  • Working range: 5.0-200000.0 mIU/mL
  • Limit of Detection (LoD): 5.0 mIU/mL

PRECISION:

  • Intra-lot Precision: Intra-lot precision was determined by testing of β-hCG reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of β-hCG reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

ACCURACY:

  •  β-hCG control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY:

  •  A serial concentration of β-hCG reference materials at 5.0-200000.0 mIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.

REAGENTS AND MATERIALS PROVIDED:

  1. Individually sealed foil pouches containing:
    a. One test device
    b. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

Instructions for Use

Catalog #

Product

Quantity

Specimen

F1000β-hCG FIA Test25/kitSerum, Plasma

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Materials required but not provided:

Catalog #

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Catalog #

Product

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To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

FOR EXPORT ONLY