Thank you, it's cool. Used for the first time because only then was the right drug. Very revealing detail: ordered Express shipping to get the order within 3 hours because didn't know how to get the order faster https://africarx.co.za/ The drug is authentic exactly. Consistent with the stated prices the Staff is knowledgeable.
Introduction
PATHOZYME PROGESTERONE Ref OD487 Enzyme Immunoassay for the quantitative determination of Progesterone in human serum or plasma. Store at 2oC to 8oC. DO NOT FREEZE. For in-vitro use only.
INTRODUCTION MATERIAL REQUIRED BUT NOT PROVIDED
Progesterone is a C21 steroid which is synthesised from both
Micropipettes: 100l, 200l, 1000l and 5000l
tissue and circulating cholesterol. Cholesterol is transformed to
pregnenolone which is then converted via a combined
dehydrogenase and isomerase to progesterone. The principle
Microplate reader fitted with a 450nm filter
production sites are the adrenals and ovaries and the placenta
during pregnancy. The majority of this steroid is metabolised in
the liver to pregnanediol and conjugated as a glucuronide prior
PRECAUTIONS
Progesterone exhibits a wide variety of end organ effects. The
primary role of progesterone is exhibited by the reproductive
PATHOZYME PROGESTERONE contains materials of human
organs. In males, progesterone is a necessary intermediate for
origin which have been tested and confirmed negative for HCV,
the production of cortcosteroids and androgens. In females,
HIV I and II antibodies and HBsAg by FDA approved methods
progesterone remains relatively constant throughout the
at single donor level. Because no test can offer complete
follicular phase of the menstrual cycle. The concentration then
assurance that products derived from human source will not
increases rapidly following ovulation and remains elevated for
transmit infectious agents it is recommended that the reagents
4-6 days and decreases to the initial level 24 hours before the
within this kit be handled with due care and attention during
onset of menstruation. In pregnancy, placental progesterone
use and disposal. All reagents should, however, be treated as
production rises steadily to levels of 10 to 20 times those of the
potential Biohazards in use and for disposal. Do not ingest.
Progesterone measurements are thus performed to determine
PATHOZYME PROGESTERONE Reagents do not contain
ovulation as well as to characterise luteal phase defects.
dangerous substances as defined by current UK Chemicals
Monitoring of progesterone therapy and early stage pregnancy
(Hazardous Information and Packaging for Supply) regulations.
evaluations comprise the remaining uses of progesterone
All reagents should, however, be treated as potential
biohazards in use and disposal. Final disposal must be in
INTENDED USE PATHOZYME PROGESTERONE is an Enzyme Immunoassay PATHOZYME PROGESTERONE Stop Solution is dilute
(EIA) for the quantitative determination of total Progesterone in
Hydrochloric Acid and is therefore corrosive. Handle with care.
In case of contact, rinse thoroughly with water.
PATHOZYME PROGESTERONE reagents contain 1.0% PRINCIPLE OF THE TEST
Proclin 300* as a preservative which may be toxic if ingested.
In case of contact, rinse thoroughly with water and seek
The PATHOZYME PROGESTERONE is based on the
principle of competitive binding between Progesterone in the
test specimen and Progesterone-HRP Conjugate for a constant amount of rabbit anti-Progesterone. In the incubation, goat
* Proclin 300 is a Trade Mark of ROHM and HAAS Ltd.
anti-rabbit IgG-coated wells are incubated with Progesterone
standards, controls, patient samples, Progesterone-HRP
Conjugate Reagent and rabbit anti-Progesterone Reagent.
Reagents must be stored at temperatures between 2oC to 8oC.
During the incubation, a fixed amount of HRP-labelled
Progesterone competes with the endogenous Progesterone in
Expiry date is the last day of the month on the bottle and the kit
the standard and sample or quality control serum for a fixed number of binding sites of the specific Progesterone antibody.
label. The kit will perform within specification until the stated
Thus, the amount of Progesterone peroxidase conjugate
expiry date as determined from date of product manufacture
immunologically bound to the well progressively decreases as
and stated on kit and components. Do not use reagents after
the concentration of Progesterone in the specimen increases.
Unbound Progesterone peroxidase conjugate is then removed
and the wells washed. The Substrate (TMB) is then added,
Exposure of reagents to excessive temperatures should be
resulting in the development of blue colour. The colour
avoided. Do not expose to direct sunlight.
development is stopped with the addition of stop solution, and
DO NOT FREEZE ANY OF THE REAGENTS as this will cause
the absorbance is measured spectrophotometrically at 450nm.
The intensity of the colour formed is proportional to the amount
of enzyme present and is inversely related to the amount of
SPECIMEN COLLECTION AND PREPARATION
unlabelled Progesterone in the sample. A standard curve is obtained by plotting the concentration of the standard versus
the absorbance. The Progesterone concentration of the
specimens and controls run concurrently with the standards
Obtain a sample of venous blood from the patient and allow a
can be calculated from the standard curve.
clot to form and retract. Centrifuge clotted blood sample and
This test has been calibrated against in house standards.
collect clear serum. Fresh serum samples are required.
There is no International standard for this test.
Obtain a sample of venous blood from the patient and add to
EDTA blood collection vial. Centrifuge sample and collect clear
plasma. Fresh plasma samples are required.
Do not use haemolysed, contaminated or lipaemic serum or
plasma for testing as this will adversly affect the results.
Microtitre Plate 12 x 8 wells x 1
Serum or plasma may be stored at 2oC to 8oC for up to 48
Breakable wells coated with Goat anti Rabbit IgG contained in a
hours prior to testing. If longer storage is required, store at –
20oC for up to 1 year. Thawed samples must be mixed prior to
Reference Standard: Human serum free of Progesterone.
Do not use Sodium Azide as a preservative as this may inhibit
0.5 ng/ml
Reference Standard: Progesterone diluted in human serum.
Do not repeatedly freeze-thaw the specimens as this will cause
3.0 ng/ml
Reference Standard: Progesterone diluted in human serum.
REAGENT PREPARATION
All reagents should be brought to room temperature (20oC to
Reference Standard: Progesterone diluted in human serum.
25oC) and mixed gently prior to use. Do not induce foaming.
Working Solution: Dilute the concentrated conjugate using 1 part conjugate to 10 parts conjugate diluent ( 1/11 dilution )
Reference Standard: Progesterone diluted in human serum. Ready to use (Colourless)
100l is required per well. Diluted reagent is stable at 2oC to
Reference Standard: Progesterone diluted in human serum.
LIMITATIONS OF USE Level as stated on vial
The use of samples other than serum and EDTA plasma have not
Known level of Progesterone diluted in human serum.
been validated in this test. There is no reuse protocol for this
product. When making an interpretation of the test it is strongly
advised to take all clinical data into consideration. Diagnosis should
Level as stated on vial
not be made solely on the findings of one clinical assay.
Known level of Progesterone diluted in human serum. Ready to use (Colourless)
Progesterone
Rabbit anti Progesterone reagent. Ready to use. (Pink) Conj
Progesterone conjugated to horseradish Peroxide Ready to use. (Blue) DIL
Phosphate based buffer containing stabilising proteins. Ready to use. ( Blue )
Substrate Solution: 3,3’, 5,5’ Tetramethyl Benzidine in a citrate buffer. Ready to use. (Colourless)
Stop Solution: Hydrochloric Acid diluted in purified water. Ready to use. (Colourless) Instruction leaflet and EIA Data Recording Sheet 1 + 1 ASSAY PROCEDURE SENSITIVITY
Bring all the kit components and the test sample to room temperature (20C to 25C) prior to
The lowest detectable level of Progesterone in this test is approximately 0.0625ng/ml
One set of Standards should be run with each batch of test sample. Secure the desired
SPECIFICITY
number of coated wells in the holder. Record the position of the standards and the test
samples on the EIA Data Recording Sheet provided.
The following materials have been checked for cross reactivity. The percentage indicates cross
Unused strips should be resealed in the foil bag containing the desiccant, using the resealing
reactivity at 50% displacement compared to Progesterone.
zip-lock before being replaced at 2C to 8C.
Data on the cross-reactivity for several endogenous and pharmaceutical steroids are summarised in
Dispense 25l of standards, test samples and controls into the appropriate wells.
Dispense 100l working solution of Progesterone-HRP Conjugate Reagent to each well.
Cross-reactivity(%) = Observed Progesterone Concentrationx100
Dispense 50l of rabbit anti-Progesterone Reagent to each well. Thoroughly mix for 30
seconds. It is very important to mix completely.
Incubate at room temperature (20oC to 25 oC) for 90 minutes.
Cross-reactivity
At the end of the incubation period, discard the contents of the wells by flicking plate contents
into a Biohazard container. Then strike the wells sharply against absorbent paper. Ensure
adequate disinfectant is contained in the Biohazard container.
Hand Washing: Fill the wells with a minimum of 300l of distilled water per well. Flick plate contents into a Biohazard container. Then strike the wells sharply against absorbent paper.
Strike the wells sharply onto absorbent paper or paper towel to remove all residual water
Machine Washing: Ensure that 300l of distilled water is dispensed per well and that an
appropriate disinfectant is added to the waste collection bottle. Wash the empty wells 5 times.
After washing remove excess fluid by striking the wells sharply onto absorbent paper or paper
EVALUATION DATA
towel to remove all residual water droplets.
Dispense 100l of Substrate solution into each well. Gently mix for 5 seconds.
Calibrated to major competitors and in house standards.
Incubate in the dark at room temperature (20C to 25C) for 20 minutes.
The co-efficient of variation of PATHOZYME PROGESTERONE is less than or equal to 10%
Stop the reaction by adding 100l of Stop Solution to each well.
Gently mix for 30 seconds. It is important to make sure that all the blue colour changes to
In an evaluation between the Omega Pathozyme Progesterone kit and the DRG BIOC Kit for samples
with levels between 0.35 ng/ml and 73.83 ng/ml the following data was generated.
Read the absorbance at 450nm with a microtitre well reader within 10 minutes.
TROUBLESHOOTING
For use by operatives with at least a minimum of basic laboratory training.
Do not use damaged or contaminated kit components.
Use a separate disposable tip for each sample to prevent cross contamination.
Duplication of all standards and specimens, although not required, is recommended.
These kits were shown to give good correlation.
Specimens and standards should be run at the same time to keep testing conditions the same.
REFERENCES
It is recommended that no more than 32 wells be used for each assay run if manual pipetting is used,
Radwanska, E., Frankenberg, J., and Allen. E., Plasma Progesterone Levels in Normal and
since pipetting of all Standards and specimens should be completed within 3 minutes. A full plate of 96
Abnormal Early Pregnancy, Fertility and Sterility 30, 398-402 (1978).
wells may be used if automated pipetting is available.
Autrere, M.B., and Benson, H., Progesterone: An Overview and Recent Advances, J. Par.
Replace caps on all reagents immediately after use.
March, C.M., Goebelsmann, U., Nakamura, R.M., and Mischell, D.R. Roles of Estradiol and
Avoid repeated pipetting from stock reagents as this is likely to cause contamination.
Progesterone in Eliciting the Midcycle Luteinising Hormone and Follicle-Stimulating Hormone
Surges. J. Clin. Endo. And Metab. 48: 507-513, (1979).
Do not mix reagents or antibody coated strips from different kits. When dispensing, care should be
Ross, G.T., Van De Wiele, R.L., and Frantz, A.G. The Ovaries and the Breasts in Textbook
taken not to touch the surface of the well.
of Endocrinology, R.H. Williams ed. P355-407, W.B. Saunders, Phil. (1981).
Chattoraj, S.C., Endocrine Function in Fundamentals of Clinical Chemistry, N.W. Tietz ed.
Do not allow reagent to run down the sides of the well. Prior to the start of the assay bring all reagents
p699-823, W.B. Saunders, Phil. Chap. 13 (1976).
to room temperature (20oC to 25oC). Gently mix all reagents by gentle inversion or swirling.
Shepard, M.K., and Fainstat, T. Comparison of Serum Progesterone and Endometrial Biopsy
for Confirmation of Ovulation and Evaluation of Luteal Function. Fertility and Sterility, 28: 541;
Once an assay has been initiated, the wells should not be allowed to become dry during the assay.
Johansson, E.D., and Johansson, L.E. Progesterone Levels in Amniotic Fluid and Plasma
Do not contaminate the Substrate Solution as this will render the whole kit inoperative.
from Women. I. Levels During Normal Pregnancy. Acta. Obstet. Gynaecol. Scand. 50: 339;
Check the precision and accuracy of the laboratory equipment used during the procedure to ensure
USA Centre for Disease Control/National Institute of Health Manual “Biosafety in
Microbiological and Biomedical Laboratories” 1984.
The unused strips should be resealed in the foil bag, containing the desiccant, using the resealing zip-
lock before being replaced at 2oC to 8oC.
QUICK REFERENCE TEST PROCEDURE CALCULATION OF RESULTS
Dispense 25l of standards, test samples, controls.
Calculate the mean absorbance value (A450) for each set of Standards, Controls and samples.
Add 100l working solution Progesterone HRP conjugate to each well.
Construct a point to point standard curve by plotting the mean absorbance obtained for each Standard
against its concentration in ng/ml on graph paper, with absorbance values on the vertical or Y-axis and
Add 50l of Rabbit anti-Progesterone into each well. Gently mix for 30 seconds.
concentrations horizontal or the X-axis.
Use the mean absorbance values for each specimen to determine the corresponding concentration of
Incubate for 90 minutes at room temperature (20oC to 25oC)
Progesterone in ng/ml from the standard curve.
If levels of controls or users known samples do not give expected results, test results must be
Discard the well contents and wash 5 times with distilled water.
If using a software package choose a polygon with data extrapolation curve fit.
Add 100l of substrate solution into each well and gently mix for 5 seconds.
EXPECTED VALUES AND SENSITIVITY
Incubate in the dark for 20 minutes at room temperature (20oC to 25oC).
The graph produced by the calibrators should be Hyperbolic in shape with the OD450 of the calibrators
Add 100l Stop Solution to each well and gently mix for 30 seconds.
inversely proportional to their concentration. The OD of calibrator A should be greater than 1.5 and the
OD of calibrator F less than 0.75 for the assay results to be valid.
Read the Optical Densities immediately (no later than 10 minutes) using a microplate
Each laboratory should establish its own normal range based on the patient population.
PATHOZYME PROGESTERONE was performed on randomly selected outpatient clinical laboratory
The results of these determinations are as follows:
OMEGA DIAGNOSTICS LTD. Omega House, Hillfoots Business Village Alva FK12 5DQ, Scotland, United Kingdom odl@omegadiagnostics.co.uk www.omegadiagnostics.com AN ISO 9001 AND ISO 13485 CERTIFIED COMPANY
AYURVEDA RHYNER ® - Ernährungsempfehlungen 2011 Gesunde Ayurveda - Ernährung für jede Konstitution »Diejenige Nahrung, welche antagonistisch zu den verursachenden Dosha einer Konstitution steht, wird für die Erhaltung der Gesundheit empfohlen. Menschen, deren Dosha sich im Gleichgewicht befinden, sollten darauf achten, Speisen zu sich zu nehmen, welche alle sechs Gesch
Minister of Health and Others vs. Treatment Action Campaign and Others 2002 (5) SA 721 (CC), 2002 10 BCLR 1033 Children's rights - basic health care services; Health rights - access to health care; Socio-economic rights - minimum core obligations; Women's rights - reproductive health. Facts This case related to a challenge brought by the Treatment Action Campaign, Dr Haroon Saloojee and