LH FIA Test

The Luteinizing Hormone (LH) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of LH in human serum using the RaFIA system. This test is intended for in vitro diagnostic use only.

LH is a protein secreted by the anterior pituitary. LH secreted intermittently stimulates Leydig cells to manufacture testosterone in males, while in females the concentration of LH is changed with menstrual cycles and ovulation. In menstrual cycles, the peak of the releasing of LH is closely related to ovarian oviposit. Once the peak LH release emerges, there is an ovarian oviposit after 24-26 hours. The best time to conceive can be insured by monitoring the concentration of LH. In other conditions, an increase of LH is also observed, such as hypogonadism, incomplete early testicle development, renal insufficiency, cirrhosis, and severe hunger.

The LH FIA Test was developed to detect the concentration of LH in serum within 20 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

RANGES

  • Working range: 1.0-200.0 mIU/mL

PRECISION

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

ACCURACY

  • LH control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY

  • A serial concentration of LH reference materials at 1.0-200.0 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

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Catalog #

Product

Quantity

Specimen

F1090LH FIA Test25/kitSerum, Plasma

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Materials required but not provided:

Catalog #

Product

FIA-100Immunofluorescence Analyzer

Catalog #

Product

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

FOR EXPORT ONLY