17-OH-Progesterone ELISA
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Product information Information about other products is available at: www.demeditec.com Demeditec Diagnostics GmbH Lise-Meitner-Strasse 2 24145 Kiel – Germany www.demeditec.com

CONTENTS / INHALTSVERZEICHNIS / CONTENIDO

1.1 Intended use The Demeditec 17-OH-Progesterone ELISA is an enzyme immunoassay for the quantitative determination of 17-OH-Progesterone in human serum and plasma (Li-Heparin). The assay is intended for in-vitro diagnostic use by professional users only. All therapeutic consequences must take not only the test result but always also all clinical and laboratory diagnostic results into account. The laboratory values themselves must never be the sole reason for therapeutic consequences derived from them. Manual processing is recommended. The usage of laboratory automats is the user’s sole...

9. Allow the reagents to reach room temperature (18-25°C) before starting the test. Temperature will affect the optical density of the assay. 10. Never pipet by mouth and avoid contact of reagents and specimens with skin and mucous membranes. 11. Do not smoke, eat, drink or apply cosmetics in areas where specimens or kit reagents are handled. 12. Wear disposable protective gloves when handling specimens and reagents. Microbial contamination of reagents or specimens may give false results. 13. Handling should be done in accordance with the procedures defined by an appropriate national...

Demeditec 17-OH-Progesterone ELISA DEH3322 4.3 Storage conditions When stored at 2-8°C, unopened reagents will be stable until expiration date. Do not use reagents beyond this date. Opened reagents must be stored at 2-8°C. After first opening the reagents are stable for 30 days if used and stored properly. Keep away from heat and direct sunlight. Microtiter plate wells must be stored at 2-8°C. Take care that the foil bag is sealed tightly. 4.4 Reagent preparation Allow the reagents and the required number of wells to reach room temperature (18-25°C) before starting the test. Wash Solution...

1. Prepare a sufficient number of microtiter plate wells to accommodate Calibrators, Controls and Samples in duplicates. 2. Dispense 25 Ml of each Calibrator, Control, and Sample with new disposable tips into appropriate wells. 3. Dispense 100 ^l Enzyme Conjugate into each well. 4. Incubate for 60 minutes at room temperature (18-25°C) on a microtiter plate shaker (900 rpm). 5. Briskly empty the contents of the wells by aspiration or by decanting. Rinse the wells 4 times with diluted Wash Solution (300 Ml per well). Strike the wells sharply on absorbent paper to remove residual droplets....

It is strongly recommended that each laboratory should determine its own normal and pathological values. Samples from apparently normal healthy adults, collected in the morning between 8 and 10 a.m. (with the exception of pregnant women), were analyzed using the Demeditec 17-OH-Progesterone ELISA. Following values are observed;_ These results alone should not be the only reason for any therapeutic consequences. They have to be correlated to other clinical observations and diagnostic tests. Good laboratory practice requires to run controls with each calibration curve. A statistically...

The following materials have been evaluated for cross reactivity. The percentage indicates cross-reactivity at 50% displacement compared to 17-OH-Progesterone.

Recovery was determined by adding increasing amounts of the analyte to three different serum samples containing different amounts of endogenous analyte. Each sample (non-spiked and spiked) was assayed and analyte concentrations of the samples were calculated from the calibrator curve. The percentage recoveries were determined by comparing expected and measured values of the samples. Reliable and reproducible results will be obtained when the assay procedure is performed with a complete understanding of the package insert instruction and with adherence to good laboratory practice. Any...

Demeditec 17-OH-Progesterone ELISA DEH3322 10.2 Drug Interferences Until today no substances (drugs) are known to us, which have an influence to the measurement of 17-OH-Progesterone in a sample. The clinical significance of the determination of 17-OH-Progesterone can be invalidated if the patient was treated with natural or synthetic steroids. Any medication should be taken into account when assessing the results. 10.3 High Dose Hook Effect A High Dose Hook Effect is not detected up to a concentration of 500 ng/ml. 11 LEGAL ASPECTS 11.1 Reliability of Results The test must be performed...

1. Lothar Thomas: Labor und Diagnose 2020 / Clinical Laboratory Diagnostics 2020 2. Abraham, G.E., R.S. Swerdloff, D. Tulchinsky et al: Radioimmunoassay of plasma 17-hydroxypro-gesterone. J. Clin. Endocrinol. Metab. 33:42, 1971 3. Chrousos, G.P., D. L. Loriaux, D.L. Mann, et al: Late onset 21- hydroxylase deficiency mimicking idiopathic hirsutism or polycystic avarian disease. Annals Intern. Med. 96:143, 1982. 4. Buster, J.E., R.J. Chang, D.L. Preston, et al: Interrelationships of circulating maternal steroids; progesterone, 16a-hydroxyprogesterone, 17a-hydroxyprogesterone,...

1.1 Zweckbestimmung Der Demeditec 17-OH-Progesterone ELISA ist ein Enzymimmunoassay zur quantitativen Bestimmung von 17-OH-Progesteron in humanem Serum und Plasma (Li-Heparin). Dieser Test ist nur für in-vitro diagnostische Anwendungen durch geschultes Laborpersonal bestimmt. Das Testergebnis muss immer alle klinischen und labordiagnostischen Ergebnisse berücksichtigen. Die Laborwerte selbst dürfen niemals der alleinige Grund für daraus abgeleitete therapeutische Konsequenzen sein. Die manuelle Abarbeitung wird empfohlen. Der darüberhinausgehende Einsatz von Laborautomaten liegt in der...

WARNUNGEN & VORSICHTSHINWEISE 1. Dieses Kit ist nur zum in-vitro diagnostischen Gebrauch geeignet und sollte nur von medizinischem Fachpersonal durchgeführt werden. 2. Vor der Testdurchführung muss die Arbeitsanleitung vollständig und sorgfältig gelesen werden und verstanden worden sein. Die gültige Version aus dem Kit verwenden. 3. Humanes Material, das bei der Herstellung verwendet wird, wurde negativ auf Antikörper gegen HIV 1&2, HbsAg und HCV getestet. Keine Testmethode kann jedoch die vollständige Sicherheit bieten, dass HIV, HBV, HCV oder andere infektiöse Erreger nicht vorhanden...