Please only refer to the current product lot insert enclosed with the kits package for execution

and reporting

0123 130298004M: 100 tests

130698004M: 050 tests

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MAGLUMI 17-OH PROGESTERONE (CLIA)
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INTENDED USE
The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of 17-OH PROGESTERONE in human
serum using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer (including Maglumi 600, Maglumi 800,
Maglumi 1000, Maglumi 2000, Maglumi 2000 Plus, Maglumi 4000 and Maglumi 4000 Plus).
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SUMMARY AND EXPLANATION OF THE TEST

Progesterone is produced from pregnenolone in all steroid-producing cells. It can then be further synthesized to
17α-hydroxyprogesterone or androstenedione. Large amounts (up to 30mg per day) are produced by the corpus luteum and by
the placenta (between 250 and 500mg per day in late pregnancy). The main site of action of progesterone is on the uterus where,
during the luteal phase, it increases the vascular bed, the tortuosity of the glands, and glandular secretion, and reduces
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myometrial activity . In this way, it prepares the uterus for implantation and supports the developing fetus. During pregnancy,
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progesterone is required for the maintenance of the placenta .
17α-Hydroxyprogesterone (17α-OHP), or hydroxyprogesterone (OHP), also known as 17α-hydroxypregn-4-ene-3, 20-dione, is
an endogenousprogestogensteroid hormone related to progester. 17α-OHP is derived from progesterone via 17α-hydroxylase
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(encoded by CYP17A1), or from 17α-hydroxypregnenolone via 3β-hydroxysteroid dehydrogenase/Δ5-4 isomerase.It is also a

chemical intermediate in the biosynthesis of many other endogenous steroids, including androgens, estrogens, glucocorticoids,
2-3
and mineralocorticoids, as well as neurosteroids .
Measurements of levels of 17α-OHP are useful in the evaluation of patients with suspected congenital adrenal hyperplasia as the
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typical enzymes that are defective, namely 21-hydroxylase and 11β-hydroxylase, lead to a build-up of 17α-OHP. In contrast, the
rare patient with 17α-hydroxylase deficiency will have very low or undetectable levels of 17α-OHP. 17α-OHP levels can also be
used to measure contribution of progestational activity of the corpus luteum during pregnancy as progesterone but not 17α-OHP
4-6
is also contributed by the placenta .
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PRINCIPLE OF THE TEST

The 17-OH PROGESTERONE assay is a competitive chemiluminescence immunoassay.
The sample (or calibrator/control, if applicable), ABEI labeled with anti-17-OH progesterone monoclonal antibodies are mixed
thoroughly and incubated at 37°C, and then the solution of the magnetic microbeads coated with 17-OH progesterone antigen is
added and incubated at 37°C. The sample and the magnetic microbeads coated with 17-OH progesterone antigen compete for
binding the ABEI Label, forming immune complexes. After precipitation in a magnetic field, decant the supernatant, and then a
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wash cycle is performed. Subsequently, the Starter 1+2 are added to initiate a chemiluminescent reaction. The light signal is
measured by a photomultiplier within 3 seconds as relative light units (RLUs), which is inversely proportional to the concentration
of 17-OH progesterone present in the sample (or calibrator/control, if applicable).

KIT COMPONENTS
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Material provided
100 tests 50 tests
Component Contents
(REF: 130298004M) (REF: 130698004M)
Magnetic 17-OH progesterone antigen coated magnetic
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2.5 mL 2.0 mL
Microbeads microbeads, containing BSA, NaN3 (<0.1%).
17-OH progesterone antigen, bovine serum, NaN3
Calibrator Low 2.5 mL 2.0 mL
(<0.1%).
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17-OH progesterone antigen, bovine serum, NaN3

Calibrator High 2.5 mL 2.0 mL
(<0.1%).
Anti-17-OH progesterone monoclonal antibody
ABEI Label 12.5 mL 7.5 mL
labeled with ABEI, containing BSA, NaN3 (<0.1%).
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Diluent Containing bovine serum, NaN3 (<0.1%). 25.0 mL 15.0 mL

17-OH progesterone antigen, bovine serum, NaN3
Control 1 2.0 mL 2.0 mL
(<0.1%).

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17-OH progesterone antigen, bovine serum, NaN3

Control 2 2.0 mL 2.0 mL
(<0.1%).
All reagents are provided ready-to-use.

Accessories Required But Not Provided

MAGLUMI Series:
Reaction Module REF: 630003
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Starter 1+2 REF: 130299004M

Wash Concentrate REF: 130299005M
Light Check REF: 130299006M
Please order accessories from Shenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE) or our authorized
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representatives.

CALIBRATION
Traceability: This method has been traceable to the SNIBE internal reference standards.
Test of assay specific calibrators allows the RLU values to adjust the assigned master curve. Results are determined via a
calibration curve which is instrument-specifically generated by 2-point calibration and a master curve(10 calibrations) provided
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via the reagent Radio Frequency Identification (RFID) CHIP.

Recalibration is recommended if any of the following conditions occurs:
 After each exchange of lots (Reagent or Starter 1+2).

 Every 2 weeks and/or each time a new reagent kit is used (recommended).
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 After instrument service is required.

 If controls lie outside the expected range.

 Whenever room temperature changes exceed 5° C (recommended).

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QUALITY CONTROL
Follow government regulations or accreditation requirements for quality control frequency.
Internal quality control is only applicable with MAGLUMI system. For instructions for use and target value refer to 17-OH
PROGESTERONE (CLIA) Quality Control Information. User needs to judge results with their own standards and knowledge.
For detailed information about entering quality control values, refer to the operating instructions of MAGLUMI series Fully-auto
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chemiluminescence immunoassay analyzer.

To monitor system performance and chart trends, commercially available quality control materials are required. Treat all quality
control samples the same as patient samples. A satisfactory level of performance is achieved when analyte values obtained are
within the acceptable Control Range for the system or within your range, as determined by an appropriate internal laboratory
quality control scheme. If the quality control results do not fall within the Expected Values or within the laboratory’s established
values, do not report results. Take the following actions:
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 Verify that the materials are not expired.

 Verify that required maintenance was performed.

 Verify that the assay was performed according to the instructions for use.

 Rerun the assay with fresh quality control samples.

 If necessary, contact your local technical support provider or distributor for assistance.
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SPECIMEN COLLECTION AND PREPARATION

 Serum collected using standard sampling tubes or tubes containing separating gel could be applied to the assay. Collect blood
aseptically following the universal precautions for venipuncture.
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 To ensure consistency in results, specimens must be transferred to a centrifuge tube and centrifuged at ≥10,000 RCF (Relative
Centrifugal Force) for 15 minutes before testing.
 Ensure that complete clot formation in specimens has taken place prior to centrifugation. Some specimens, especially those
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from patients receiving anticoagulant or thrombolytic therapy, may exhibit increased clotting time.
 If the specimen is centrifuged before a complete clotting, the presence of fibrin may cause erroneous results. Samples must be
free of fibrin and other particulate matter.
 Do not use hemolyzed or grossly lipemic specimens as well as specimens containing particulate matter or exhibiting obvious
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microbial contamination. Inspect all specimens for bubbles, and remove bubbles before analysis for optimal results.
 Avoid repeating freezing and thawing. The serum sample can be frozen and thawed for two times. Stored samples should be
thoroughly mixed prior to use (Vortex mixer). Frozen specimens must be mixed thoroughly after thawing by low speed
vortexing. Please ask local representative of SNIBE for more derails if you have any doubt.

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 Centrifuged specimens with a lipid layer on the top must be transferred to a sample cup or a secondary tube. Care should be
taken to transfer only the clarified specimen without the lipemic material.
 All samples (Patient specimens or controls) should be tested within 3 hours when placed on board the MAGLUMI System.
Refer to the SNIBE service for more details discussion of onboard sample storage constraints.
 If testing will be delayed for more than 8 hours, remove serum from the serum separator, red blood cells or clot. Specimens
removed from the separator, cells or clot may be stored up to 72 hours at 2-8°C, and stored up to 3 months frozen at -20°C or
colder.
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 Before shipping specimens, it is recommended that specimens be removed from the serum separator, red blood cells or clot.
When shipped, specimens should be packaged and labeled in compliance with applicable state, federal and international
regulations covering the transport of clinical specimens and infectious substances. Specimens should be shipped frozen.
 The sample volume required for a single determination of 17-OH PROGESTERONE is 40 µL.

WARNING AND PRECAUTIONS FOR USERS

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
 For In Vitro Diagnostic Use.
 Follow the package insert carefully. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
Safety Precautions
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 CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials be

considered potentially infectious and handled in accordance with the 29 CFR 1910.1030 Occupational exposure to bloodborne
pathogens. Biosafety Level 2 or other appropriate biosafety practices should be used for materials that contain or are
suspected of containing infectious agents.
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 All samples, biological reagents and materials used in the assay should be considered potentially able to transmit infectious

agents. They should therefore be disposed of in accordance with the practices of your institution. Discard all materials in a safe
and acceptable manner and in compliance with prevailing regulatory requirements.
 This product contains Sodium Azide. Dispose of contents and containers must be in accordance with all local, regional and
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national regulations.
 Refer to safety data sheets which are available on request.

Handling Precautions
 Do not use reagent kits beyond the expiration date.

 Do not interchange reagent components from different reagents or lots.

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 Prior to loading the reagent kit on the system for the first time, the reagent rit requires mixing to re-suspend magnetic

microbeads that have settled during shipment.

 For magnetic microbeads mixing instructions, refer to the Preparation of the reagent section of this package insert.

 To avoid contamination, wear clean gloves when operating with a reagent kit and sample.

 Over time, residual liquids may dry on the septum surface. These are typically dried salts which have no effect on assay efficacy.

 For detailed discussion of handling precautions during system operation, refer to the SNIBE service information.
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STORAGE AND STABILITY

 Sealed: Stored at 2-8°C until the expiration date.
 Opened at 2-8°C: Minimum stability is 4 weeks.
 On-board : Minimum stability is 4 weeks.
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 To ensure the best kit performance, it is recommended to place opened kits in the refrigerator after the end of the intraday test
work. It is still possible to keep on using the kit beyond the opened or on-board period if the controls are found within the
expected ranges.
 Keep upright for storage to facilitate later proper resuspension of magnetic microbeads.
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 Keep away from sunlight.

TEST PROCEDURE
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Preparation of the Reagent

 Resuspension of the magnetic microbeads takes place automatically when the kit is loaded successfully, ensuring the magnetic

microbeads are totally resuspended homogenous prior to use.

 To ensure proper test performance, strictly adhere to the operating instructions of MAGLUMI series Fully-auto
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chemiluminescence immunoassay analyzer. Each test parameter is identified via a RFID CHIP on the Reagent. For further
information please refer to the operating instructions of MAGLUMI series Fully-auto chemiluminescence immunoassay
analyzer.

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DILUTION
Samples with concentrations above the measuring range can be diluted.
After manual dilution, multiply the result by the dilution factor. After dilution by the analyzers, the analyzer software automatically
takes the dilution into account when calculating the sample concentration.
The automatic sample dilution is available after dilution settings are done in the MAGLUMI series Fully-auto chemiluminescence
immunoassay analyzer user software. Please refer to the operating instructions of MAGLUMI series Fully-auto
chemiluminescence immunoassay analyzer.
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LIMITATIONS
 A skillful technique and strict adherence to the instructions are necessary to obtain reliable results.
 Bacterial contamination or heat inactivation of the specimens may affect the test results.
 A result within the expected range does not rule out the presence of disease and should be interpreted together with the
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patient’s clinical picture and other diagnostic procedures.

 Diagnosis of a disease should not be based on the result of a single test, but should be determined in conjunction with clinical
findings in association with medical judgement.
 Any therapeutical decision should also be taken on a case-by-case basis.
 Degradation of the molecule or prorenin cryoactivation may affect final results.
 Patient samples containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values. Although
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HAMA-neutralizing agents are added, extremely high HAMA plasma concentrations may occasionally influence results.

RESULTS
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Calculation of Results
The analyzer automatically calculates the 17-OH PROGESTERONE concentration in each sample by means of a calibration curve
which is generated by a 2-point calibration master curve procedure. The results are expressed in ng/mL. For further information
please refer to the operating instructions of MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer.
Interpretation of Results
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The reference intervals:

New born Girls Boys
1 month 2.4-16.8 ng/mL 0.0-8.0 ng/mL
2 months 1.6-9.7 ng/mL 3.6-13.7 ng/mL
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3 months 0.1-3.1 ng/mL 1.7-4.0 ng/mL

Children 3-14 years old 0.1-1.7 ng/mL

Follicular phase 0.1-0.8 ng/mL
Luteal phase 0.6-2.3 ng/mL
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Ovulatory period 0.3-1.4 ng/mL

Adult females
Post ACTH <3.2 ng/mL
Late pregnancy 2.0-12 ng/mL
Menopause 0.13-0.51 ng/mL
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Normal males 0.5-2.1 ng/mL

Results may differ between laboratories due to variations in population and test method. It is recommended that each laboratory
establish its own expected ranges.
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PERFORMANCE CHARACTERISTICS
Precision
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Precision for the 17-OH PROGESTERONE assay was determined as described in the CLSI EP5-A2. 2 controls and 3 human
serum pools containing different concentration of analyte were assayed in duplicate at two independent runs per day for 20 testing
days. The result is summarized in the following table:
Mean(ng/mL) Within-Run Between-Run Total
Sample
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(N=80) SD(ng/mL) %CV SD(ng/mL) %CV SD(ng/mL) %CV

Serum Pool 1 0.512 0.033 6.45 0.019 3.71 0.038 7.42
Serum Pool 2 5.921 0.314 5.30 0.202 3.41 0.387 6.54
Serum Pool 3 15.975 0.688 4.31 0.635 3.97 0.936 5.86

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Control 1 3.997 0.254 6.36 0.117 2.93 0.280 7.01

Control 2 11.976 0.686 5.73 0.333 2.78 0.762 6.36

Limit of Blank (LoB)

The LoB for the 17-OH PROGESTERONE assay is 0.1 ng/mL.

Limit of Detection (LoD)

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The LoD for the 17-OH PROGESTERONE assay is 0.15 ng/mL.

Measuring Range
0.1-20 ng/mL (defined by the limit of blank and the maximum of the master curve). Values below the limit of blank are reported as
<0.1 ng/mL. Values above the measuring range are reported as >20 ng/mL.
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Linearity
The assay is linear between 0.15 ng/mL and 20 ng/mL based on a study performed with guidance from CLSI EP6-A. Nine equally
distributed levels of samples were prepared by blending a serum sample containing 21 ng/mL with a serum sample depleted of
17-OH Progesterone (0.0 ng/mL). The mean sample recovery ranged from 90% to 110%.
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Method Comparison
A total of 1123 samples in the range of 0.102 to 19.99 ng/mL were tested by the 17-OH PROGESTERONE assay (y) and a
commercially available immunoassay (x). The data from the resulting linear regressions are summarized as:
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y=0.9919x+0.0289, r =0.9751.
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Analytical Specificity
The specificity date of the assay was obtained by adding these cross-reactant at the indicated concentrations to serum samples.
The table below lists the substances tested and the concentration at which no significant interference was observed:
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Compound Concentration
Progesterone 80 ng/mL
Estriol 80 ng/mL
Estradiol 6 ng/mL
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Testosterone 17 ng/mL
Dehydroepiandrosten sulfate 1000 μg/dL
Aldosterone 2 ng/mL
Cortisol 600 ng/mL
Dihydrotestosterone 1 μg/mL
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Endogenous Interference
Substances up to the following concentrations did not interfere with the assay:
 Bilirubin 24 mg/dL
 Hemoglobin 1000 mg/dL
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 Triglyceride 1400 mg/Dl

 ANA +++ (High positive sample)
 RF 1500 IU/mL
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 HAMA 30 ng/mL

REFERENCES
1. Wild D. The Immunoassay Handbook-the theory and applications of ligand binding, ELISA and related techniques, Fourth
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Edition. Elsevier Ltd. 2013.

2. J. Elks (14 November 2014). The Dictionary of Drugs: Chemical Data: Chemical Data, Structures and Bibliographies.
Springer. pp. 664–665.
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3. I.K. Morton; Judith M. Hall (6 December 2012). Concise Dictionary of Pharmacological Agents: Properties and Synonyms.
Springer Science & Business Media.
4. Seren E, Tamanini C, Gaiani R, et al. Concentrations of progesterone, 17α-hydroxyprogesterone and
20α-dihydroprogesterone in the plasma of mares during pregnancy and at parturition[J]. Journal of reproduction and fertility,
1981, 63(2): 443-448.

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 Please only refer to the current product lot insert enclosed with the kits package for execution and reporting

5. Torresani T, Grüters A, Scherz R, et al. Improving the efficacy of newborn screening for congenital adrenal hyperplasia by
adjusting the cut-off level of 17α-hydroxyprogesterone to gestational age[J]. Screening, 1994, 3(2): 77-84.
6. Turpeinen U, Itkonen O, Ahola L, et al. Determination of 17α‐hydroxyprogesterone in serum by liquid chromatography ‐
tandem mass spectrometry and immunoassay [J]. Scandinavian journal of clinical and laboratory investigation, 2005, 65(1):
3-12.

Shenzhen New Industries Biomedical Engineering Co., Ltd.

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No.16, Jinhui Road, Pingshan New District, Shenzhen, 518122, P.R.China

Tel: 0086-755-21536601 Fax: 0086-755-28292740

Lotus Global Co., Ltd.

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1 Four Seasons Terrace, West Drayton, Middlesex London, UB7 9GG, United Kingdom
Tel: 0044-20-75868010 Fax: 0044-20-79006187

SYMBOLS EXPLANATIONS

Consult instructions for use Manufacturer

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Temperature limit
Use-by date
( Store at 2-8 °C)
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Contains sufficient for Keep away from sunlight

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Authorized representative in the

This way up
European Community

In vitro diagnostic medical device Kit component

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Catalogue number Batch code

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