FDA 510(k) cleared for the quantitative determination of TSH (thyroid stimulating hormone, thyrotropin) in blood dried on filter paper.

Screening for Congenital Hypothyroidism (CH) is important for the prevention of irreversible mental retardation. Determination of TSH in neonatal blood dried on filter paper (the Guthrie Card) is used as a primary screening test or as a measure of iodine deficiency in adult populations.

The test is based on the "antibody sandwich" principle. 3mM discs punched from standard, control and patient blood filter paper are added to Anti-TSH Antibody-coated MicroPlate wells. A buffer solution is added to effect elution of the TSH from the blood spot. The TSH is bound to the antibody-coated wells. This solid phase antibody is referred to as the "capture" antibody. Following a wash, Peroxidase-conjugated monoclonal anti-TSH antibody is added which is specific for an epitope of TSH distal to that of the capture antibody. When TSH is present, this two-sited interaction results in a bridge or sandwich with the two antibodies on the ends and TSH in the middle.

Following a final wash, the Color Reagent for peroxidase is added. After an incubation the reaction is stopped and absorbance is measure using a MicroPlate spectrophotometer. The concentration of TSH is directly proportional to the color (yellow). The concentration of the unknown sample is determined from a standard dose-response curve.

With the SPOTCHECK system, laboratories can offer same day turnaround of quantitative patient results. In most cases, results can be obtained before the early discharge of the newborn. This allows the physician to respond more effectively to a potentially critical condition. Designed for expansion and flexibility, the SPOTCHECK system maximizes the initial investment. Astoria-Pacific is committed to continuing the years of excellence into the future through its products, research and customer service.
 

SPOTCHECK Automation System can run six tests including  Phenylalanine, Total Galactose, Uridyltransferase, Tyrosine, Biotinidase Deficiency, and G6PD Deficiency. Each testing kit contains all necessary reagents needed for analysis and will provide approximately 50 hours of analyzer run time. Allowing for start up and calibrants, the approximate number of actual samples analyzed per kit is conservatively 2500-3000.

For more information about SPOTCHECK, please look at www.astoria-pacific.com/spotcheck