Quantitative test is based on the principle of
2. Dispense 10 uL of standards, controls or
competes with enzyme-labeled-Progesterone
3. Progesterone Antibody Solution (6 mL)
Progesterone
for a fixed and limited number of antibody
3. Dispense 50 uL of antibody solution into
In the assay procedure, the Progesterone
standard or patient serum is incubated with
NAME AND INTENDED USE
conjugate in the anti-mouse IgG coated well.
In this solid-phase system, the antibody
bound Progesterone will remain on the well
Quantitative SH-301 is a solid phase enzyme
while unbound Progesterone will be removed
linked immunosorbent assay (ELISA). This
TMB substrate, is mixed with the antibody
7. TMB Solution (11 mL): Buffer solution
test provides quantitative measurement of
bound Progesterone-horseradish peroxidase
enzyme conjugate. After a short incubation,
9. Well holder for securing individual wells.
microreader at 450 nm. When high levels of
SUMMARY AND EXPLANATION OF TEST MATERIALS REQUIRED BUT NOT
enzyme conjugate is bound; then, less color
PROVIDED
Progesterone (Pregn-4-ene-3, 20-dione) is a
C21 steroid hormone. The molecular weight
2. Pipetor with tip for 10 uL, 50 uL and
PROCEDURAL NOTE
Progesterone is a female sex hormone that
WARNING AND PRECAUTION
in conjunction with estrogens, regulates the
1. Azide and thimerosal at concentration
accessory organs during the menstrual cycle
higher than 0.01% interfere in this test;
and it is particularly important in preparing
Quantitative is designed for in vitro use
SPECIMEN COLLECTION AND HANDLING
the endometrium for the implantation of the
blastocyte and in maintaining pregnancy. In
2. The components in this kit are intended
Collect blood by venipuncture, allow clotting,
non-pregnant women progesterone is mainly
and separating the serum by centrifugation
secreted by the corpus luteum whereas in
3. The components of different lots should
pregnancy the placenta becomes the major
assayed immediately, they can be stored at
exchange strips of different plates even
2 - 8oC or frozen for few days. Do not use
cortex for both sexes and the testes for
hyperlipemic, hemolyzed, contaminated or
3. Pippet all reagents and samples into the
heat inactivated sample as they may cause
conditions, and the characteristics of the
bound to Corticosteroid Binding globulin
4. Absorbance is a function of the time and
(CBG), Sex Hormone Binding globulin (SHBG)
PREPARATION FOR ASSAY STORAGE AND STABILITY
concentration circulates as free hormone.
Store the kits at 2-8oC in the refrigerator.
Keep microwells in dry bag with desiccants.
are clinically used to confirm ovulation and
The reagents are stable until expiration of
2. Before the start of the assay. Once the
normal function of the corpus luteum in non-
the kit. The calibrators and conjugate are
stable for 8 weeks after first opening. TMB
without any interruption to get the most
substrate solution should be colorless; if the
Abnormal progesterone secretion has been
solution turns blue, it must be replaced. Do
implicated in premenstrual tension, irregular
not expose these reagents to strong light
MATERIALS PROVIDED CALCULATION OF RESULTS PRINCIPLE OF THE ASSAY ASSAY PROCEDURE
1. Microwell strips (96 wells): anti-mouse
standards, controls and patient samples.
REFERENCES PERFORMANCE CHARACTERISTICS
control at several levels to monitor assay
performance. The control should be treated
PRECISION
as unknown. Results obtained should be in
agreement with the assigned value of the
Intra-assay and Inter-assay coefficient of
involving the biotin-streptavidin system
reference standard against it’s A/Ao x
control. The controls can be obtained from
variation were evaluated at three different
commercially available sources, but should
not contain sodium azide as preservatives.
Intra - assay LIMITATION
3. Elder P.A., K.H.J. Yeo, J.G. Lewis, and
variable results samples containing > 40
ng/mL Progesterone can be diluted with the
Inter - assay Calibrators Absorbnce A/Ao x 100 Calculated
containing <0.4 ng/mL are analyzed by
Controls
calibrator with the 0 calibrator to extend the
ACCURACY UNITED BIORESEARCH INC.
Recovery studies were performed by mixing
an aliquot of pooled serum and progesterone
clinical finding or impressions, clinical
judgment should be exercised and additional
EXPECTED VALUE
1. It is recommended that each laboratory
SPECIFICITY Compounds Reactivity The Concentration of Progesterone QUALITY CONTROL
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Shelley is a 32-year-old mother of two beautiful girls. This person grew up with red spots on the face. Since this did not pose any problems, these wereperceived to be freckles that people get in the teenage years, which will eventually go away as the individual, gets older. Unfortunately, this remaineduntil Shelley was much older and was shocked with the diagnosis given by the doctor. The speci