DRG EIA-2330 5α Dihydrotestosterone Diagnostics Instruction Manual

DRG EIA-2330 5α Dihydrotestosterone Diagnostics

Product Information

Specifications

Product Name: 5 Dihydrotestosterone (DHT) ELISA EIA-2330

Manufacturer: DRG Instruments GmbH, Germany
Intended Use: For quantitative measurement of Dihydrotestosterone (DHT) in human serum by ELISA

For Professional Use Only
For In Vitro Diagnostic Use Only

Product Usage Instructions

Intended Purpose & Use
This kit is designed for the quantitative measurement of Dihydrotestosterone (DHT) in human serum using an Enzyme-Linked Immunosorbent Assay (ELISA). It is intended for professional use in laboratory settings only. The kit can be used manually but may also be adaptable to open automated analyzers. The user is responsible for validating its performance with any automated analyzers.

Limitations Related to Intended Purpose & Use

This test is not intended for screening purposes.
Not for home testing or self-testing.

Calibrated for DHT measurement in human serum only.
Results should not be the sole basis for clinical diagnosis or therapeutic decisions.

Potential interferences from untested substances like drugs or heterophilic antibodies.

Supplemental Information
Main clinical indications for DHT measurement include investigations of delayed puberty in men and evaluation of active testicular tissue presence.

Principle of the Test
The test measures DHT levels in human serum using an ELISA method.

Procedural Cautions and Warnings

Kit for use by trained laboratory personnel only.
Handle reagents and specimens following good laboratory practices.

Understand and strictly adhere to the protocol provided for reliable performance.
Do not use expired or visibly damaged kit reagents.

Avoid mixing components from different kit lots within a test.
All reagents and specimens must be at room temperature before use.

Use deionized or distilled water for dilution/reconstitution when specified.
Return kit components to the recommended storage temperature after use.

Establish a calibrator curve for each run.

Frequently Asked Questions (FAQ)

Q: Can this test be used for home testing?
A: No, this test is intended for professional use in laboratory settings only and is not suitable for home testing or self-testing.
Q: What are some common interferences that may affect the test results?
A: Common interfering substances have been evaluated, but other untested substances like drugs or heterophilic antibodies may cause interferences.

Please use only the valid version of the Instructions for Use provided with the kit.

INTENDED PURPOSE & USE

For the quantitative measurement of Dihydrotestosterone (DHT) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).

This kit is intended for professional use only and is for laboratory use only.

For in vitro diagnostic use only.
Intended to be used manually but may be adaptable to open automated analyzers. The user is responsible for validating the performance of this kit with any automated analyzers.

LIMITATIONS RELATED TO INTENDED PURPOSE & USE

This test is not intended to be used for screening purposes.
This test is not intended for home testing or self-testing.
The kit is calibrated for the determination of DHT in human serum. The kit is not calibrated for the determination of DHT in other specimens of human or animal origin.
The results obtained with this kit shall never be used as the sole basis for a clinical diagnosis and therapeutic decisions.
Although common interfering substances have been evaluated with this test, other substances that have not been evaluated such as drugs and the occurrence of heterophilic antibodies in individuals regularly exposed to animals or animal products have the potential to cause interferences.

SUPPLEMENTAL INFORMATION

Dihydrotestosterone (DHT) is the most active natural androgen in humans with a principal role in the development of primary and secondary sexual characteristics and potential participation in a myriad of other physiological processes. The bulk of androgen production takes place mainly in the Leydig cells of the testes. Androgens circulate in the blood bound to proteins, especially sex hormone binding globulin (SHBG) from peripheral conversion of testosterone, while in females most of the DHT is derived from androstenedione. Some of the main clinical indications of the DHT measurement in serum are investigations of delayed puberty in men and evaluation of the presence of active testicular tissue1.

PRINCIPLE OF THE TEST

The 5alpha-Dihydrotestosterone ELISA is a competitive immunoassay. Competition occurs between DHT present in calibrators, controls, specimen samples, and an enzyme-labeled antigen (HRP conjugate) for a limited number of anti-DHT antibody binding sites on the microplate wells. After a washing step that removes unbound materials, the TMB substrate (enzyme substrate) is added which reacts with HRP to form a blue-colored product that is inversely proportional to the amount of DHT present. Following incubation, the enzymatic reaction is terminated by the addition of the stopping solution, converting the color from blue to yellow. The absorbance is measured on a microplate reader at 450 nm. A set of calibrators is used to plot a calibrator curve from which the amount of DHT in specimen samples and controls can be directly read.

PROCEDURAL CAUTIONS AND WARNINGS

This kit is for use by trained laboratory personnel (professional use only). For laboratory in vitro use only.
Practice good laboratory practices when handling kit reagents and specimens. This includes:
- Do not pipette by mouth.
- Do not smoke, drink, or eat in areas where specimens or kit reagents are handled.
- Wear protective clothing and disposable gloves.
- Wash hands thoroughly after performing the test.
- Avoid contact with eyes; use safety glasses; in case of contact with eyes, flush eyes with water immediately and contact a doctor.
Users should have a thorough understanding of this protocol for the successful use of this kit. Reliable performance will only be attained by strict and careful adherence to the instructions provided.

Do not use the kit beyond the expiry date stated on the label.
If the kit reagents are visibly damaged, do not use the test kit.
Do not use kit components from different kit lots within a test and do not use any component beyond the expiration date printed on the label.

All kit reagents and specimens must be brought to room temperature and mixed gently but thoroughly before use. Avoid repeated freezing and thawing of specimens.
When the use of water is specified for dilution or reconstitution, use deionized or distilled water.
Immediately after use, each component of the kit must be returned to the recommended storage temperature stated on the label.

A calibrator curve must be established for every run.
It is recommended to all customers to prepare their control materials or serum pools which should be included in every run at a high and low level for assessing the reliability of results.
The controls (included in the kit) must be included in every run and their results must fall within the ranges stated in the quality control certificate; a failed control result might indicate improper procedural techniques or pipetting, incomplete washing, or improper reagent storage.

When dispensing the substrate and stopping solutions, do not use pipettes in which these liquids will come into contact with any metal parts.
The TMB Substrate is sensitive to light and should remain colorless if properly stored. Instability or contamination may be indicated by the development of a blue color, in which case it should not be used.
Do not use grossly hemolyzed, grossly lipemic, icteric, or improperly stored serum.

Samples or controls containing azide or thimerosal are not compatible with this kit, they may lead to false results.
Sample values above the measuring range of the kit may be reported as >2500 pg/mL. If further dilution and retesting are required, only serum samples with a known low DHT concentration (< 50 pg/mL) may be used to dilute serum samples. The use of any other reagent may lead to false results.
Avoid microbial contamination of reagents.

To prevent the contamination of reagents, use a new disposable pipette tip for dispensing each reagent, sample, calibrator, and control.
To prevent the contamination of reagents, do not pour reagents back into the original containers.
Kit reagents must be regarded as hazardous waste and disposed of according to local and/or national regulations.

Consumables used with the kit that is potentially biohazardous (e.g., pipette tips, bottles, or containers containing human materials) must be handled according to biosafety practices to minimize the risk of infection and disposed of according to local and/or national regulations relating to biohazardous waste.
This kit contains 1 M sulfuric acid in the stopping solution component. Do not combine acid with waste material containing sodium azide or sodium hypochlorite.
The use of safety glasses, and disposable plastic, is strongly recommended when manipulating biohazardous or bio-contaminated solutions.

Proper calibration of the equipment used with the test, such as the pipettes and absorbance microplate reader, is required.
If a microplate shaker is required for the assay procedure, the type and speed of the shaker required is stated in the REAGENTS AND EQUIPMENT NEEDED BUT NOT PROVIDED section. Both the type and speed of the shaker used can influence the optical densities and test results. If a different type of shaker and/or speed is used, the user is responsible for validating the performance of the kit.
Do not reuse the microplate wells, they are for SINGLE USE only.

To avoid condensation within the microplate wells in humid environments, do not open the pouch containing the microplate until it has reached room temperature.
When reading the microplate, the presence of bubbles in the wells will affect the optical densities (ODs). Carefully remove any bubbles before performing the reading step.
Any serious incident that has occurred about the device shall be reported to the manufacturer and the competent authority of the European Member State in which the user and/or the patient are established.

SAFETY CAUTIONS AND WARNINGS

BIOHAZARDS

The reagents should be considered a potential biohazard and handled with the same precautions applied to blood specimens. All human specimens should be considered a potential biohazard and handled as if capable of transmitting infections and by good laboratory practices.
The calibrators and controls provided with the kit contain processed human serum/plasma that has been tested by approved methods and found to be negative for the presence of HBsAg and antibodies to HCV, HIV 1/2, and HIV NAT.

However, no test method can offer complete assurance that any viable pathogens are absent. Therefore, these components should be considered a potential biohazard and handled with the same precautions as applied to any blood specimen, following good laboratory practices.

CHEMICAL HAZARDS
Avoid direct contact with any of the kit reagents. Specifically, avoid contact with the TMB Substrate (contains tetramethylbenzidine) and Stopping Solution (contains sulfuric acid). If contact with any of these reagents, wash with plenty of water and refer to SDS for additional information.

SPECIMEN COLLECTION, STORAGE AND PRE-TREATMENT

SPECIMEN COLLECTION & STORAGE
Approximately 0.1 mL of serum is required per duplicate determination. Collect 4 – 5 mL of venous blood into an appropriately labeled tube and allow it to clot. Centrifuge at room temperature and carefully transfer the serum into a new storage tube or container. Serum samples may be stored at room temperature for up to seven days, at 2 °C – 8 °C for up to fourteen days, or frozen at or below -20 °C for up to 1 month.
Consider all human specimens as possible biohazardous materials and take appropriate precautions when handling them.

SPECIMEN PRE-TREATMENT
Specimen pre-treatment is not required.

REAGENTS AND EQUIPMENT NEEDED BUT NOT PROVIDED

Calibrated single-channel pipette to dispense 50 μL.
Calibrated multi-channel pipettes to dispense 50 μL, 100 µL, and 150 μL.

Calibrated multi-channel pipettes to dispense 350 μL (if washing manually).
Automatic microplate washer (recommended).
Disposable pipette tips.

Distilled or deionized water.
Calibrated absorbance microplate reader with a 450 nm filter and an upper OD limit of 3.0 or greater.

REAGENTS PROVIDED

Quantity	Symbol	Component
1 x 12 x 8	MTP	Microtiter Plate Ready to use One anti-DHT polyclonal antibody-coated 96-well (12×8) microplate in a resealable pouch with desiccant. Storage at 2 °C – 8 °C. Unopened: Stable until the expiry date printed on the label. After opening: Stable for four weeks at 2 °C – 8 °C.
1 x 15 mL	ENZCONJ	Enzyme Conjugate Ready to use Containing DHT-Horse Radish Peroxidase (HRP) conjugate in a protein-based buffer with a non-mercury preservative. Storage at 2 °C – 8 °C. Unopened: Stable until the expiry date printed on the label. After opening: Stable for four weeks at 2 °C – 8 °C.
1 x 7 x 1.0 mL	CAL A-G	Standards / Calibrators A-G Ready to use. Listed below are approximate concentrations, please refer to vial labels for exact concentrations. 0, 25; 100; 250; 500; 1000; 2500 pg/mL Containing DHT in a human serum-based matrix with a non-mercury preservative. Prepared by a spiking matrix with defined quantities of DHT. Storage at 2 °C – 8 °C. Unopened: Stable until the expiry date printed on the label. After opening: Stable for four weeks at 2 °C – 8 °C.
1 x 2 x 1.0 mL	CONTROL HIGH CONTROL LOW	Control High and Control Low Ready to use. Containing DHT in a human serum-based matrix with a non-mercury preservative. Prepared by a spiking matrix with defined quantities of DHT. Refer to vial labels for the acceptable ranges. Storage at 2 °C – 8 °C. Unopened: Stable until the expiry date printed on the label. After opening: Stable for four weeks at 2 °C – 8 °C.
1 x 18 mL	TMB SUBS	TMB Substrate Solution Ready to Use. Contains tetramethylbenzidine and hydrogen peroxide in a non-DMF or DMSO-containing buffer. Storage at 2 °C – 8 °C. Unopened: Stable until the expiry date printed on the label. After opening: Stable for four weeks at 2 °C – 8 °C.
1 x 8 mL	TMB STOP	TMB Stop Solution Ready to Use. Containing 1 M H2SO4. Storage at 2 °C – 8 °C. Unopened: Stable until the expiry date printed on the label. After opening: Stable for four weeks at 2 °C – 8 °C.
2 x 50 mL	WASHBUF CONC	Wash Buffer, Concentrate (10x) Requires Preparation Containing a buffer with a non-ionic detergent and a non-mercury preservative. Storage at 2 °C – 8 °C. Unopened: Stable until the expiry date printed on the label. After opening: Stable for four weeks at 2 °C – 8 °C. Following Preparation: The working wash buffer is stable for 2 weeks following preparation, assuming Good Laboratory Practices are adhered to. To prevent microbial growth, prepare the wash buffer working solution in a clean container and store it under refrigerated conditions (2 °C – 8 °C) when not in use. To prepare the working wash buffer that is used for washing the microplate, dilute the wash buffer concentrate 1:10 in distilled or deionized water before use. If the whole microplate is to be used, add 50 mL of the wash buffer concentrate to 450 mL of deionized or distilled water.

ASSAY PROCEDURE

Specimen Pre-Treatment: None.

All kit components, controls, and specimen samples must reach room temperature before use. Calibrators, controls, and specimen samples should be assayed in duplicate. Once the procedure has been started, all steps should be completed without interruption.

After all kit components have reached room temperature, mix gently by inversion.
Prepare the working wash buffer (See the Reagents Provided section, Wash Buffer Concentrate).

Plan the microplate wells to be used for calibrators, controls, and samples. See the Recommended Assay Layout section. Remove the strips that will not be used from the microplate frame and place them in the bag with desiccant. Reseal the bag with the unused strips and return it to the refrigerator.
Pipette 50 μL of each Calibrator, Control, and specimen sample into correspondingly labeled wells in duplicate.
Pipette 100 μL of the Enzyme Conjugate into each well (the use of a multi-channel pipette is recommended).

Gently tap the microplate frame for 10 seconds to mix the contents of the wells and incubate the microplate at room temperature (no shaking) for 90 minutes.
Wash the wells either with an automatic microplate washer (preferred) or manually as stated below.
- Automatic: Using an automatic microplate washer, perform a 3-cycle wash using 350 μL/well of Wash Buffer Working Solution (3 x 350 μL). One cycle consists of aspirating all wells and then filling each well with 350 μL of Wash Buffer Working Solution. After the final wash cycle, aspirate all wells and then tap the microplate firmly against absorbent paper to remove any residual liquid.
- Manually: For manual washing, perform a 3-cycle wash using 350 μL/well of Wash Buffer Working Solution (3 x 350 μL). One cycle consists of aspirating all wells by briskly emptying the contents of the wells over a waste container, then pipetting 350 μL of Wash Buffer Working Solution into each well using a multi-channel pipette. After the final wash cycle, aspirate all wells by briskly emptying the contents over a waste container and then tap the microplate firmly against absorbent paper to remove any residual liquid.
Pipette 150 μL of TMB Substrate into each well (the use of a multi-channel pipette is recommended).
Incubate the microplate at room temperature (no shaking) for 30 minutes.

Pipette 50 μL of TMB Stop Solution into each well (the use of a multi-channel pipette is recommended) in the same order and speed as was used for the addition of the TMB Substrate Solution. Gently tap the microplate frame to mix the contents of the wells.
Measure the optical density (absorbance) in the microplate wells using an absorbance microplate reader set to 450 nm, within 20 minutes after the addition of the TMB Stop Solution.

CALCULATIONS

Calculate the mean optical density for each calibrator, control, and specimen sample duplicate.

Use a 4-parameter or 5-parameter curve fit with immunoassay software to generate a calibrator curve.
The immunoassay software will calculate the concentrations of the controls and specimen samples using the mean optical density values and the calibrator curve.
If a sample reads more than 2500 pg/mL and needs to be diluted and retested, then dilute with a serum sample with a known low DHT concentration (< 50 pg/mL) not more than 1:10. The result obtained must be multiplied by the dilution factor.

QUALITY CONTROL

When assessing the validity of the test results, the following criteria should be evaluated:

The calibrator A mean optical density meets the acceptable range as stated in the QC Certificate.
The calibrator with the highest concentration meets the % binding acceptable range as stated in the QC Certificate.% Binding = (OD of calibrator/OD of calibrator A) x 100.

The values obtained for the kit controls are within the acceptable ranges as stated in the QC certificate.
The results of any external controls that were used meet the acceptable ranges.

TYPICAL DATA

TYPICAL TABULATED DATA
Sample data only. Do not use it to calculate results.

Calibrator	Mean OD (450 nm)	% Binding	Value (pg/mL)
A	2.664	100 %	0 pg/mL
B	2.225	84 %	25 pg/mL
C	1.695	64 %	100 pg/mL
D	1.261	47 %	250 pg/mL
E	0.911	34 %	500 pg/mL
F	0.622	23 %	1000 pg/mL
G	0.372	14 %	2500 pg/mL
Unknown	1.077	40 %	353 pg/mL

TYPICAL CALIBRATOR CURVE
Sample curve only.

Do not use it to calculate results.

PERFORMANCE CHARACTERISTICS

SENSITIVITY
The analytical sensitivity study was performed according to the CLSI EP17-A2 guideline. Sixty replicates of the matrix and low-concentration samples were run in independent tests with three lots of the kit. The Limit of Background (LoB) was determined to be 9.4 pg/mL, the Limit of Detection (LoD) was determined to be 17.0 pg/mL and the Limit of Quantitation (LoQ) was determined to be 17.0 pg/mL.

SPECIFICITY (CROSS-REACTIVITY)
The following compounds were tested for cross-reactivity with DHT cross-reacting at 100 %.

Compound	% Cross-Reactivity
5α-DHT	100 %
17-hydroxyprogesterone	< 0.01 %
17β-estradiol	< 0.01 %
Aldosterone	< 0.01 %
Androstenedione	0.6 %
Corticosterone	< 0.01 %
Cortisol	< 0.01 %
Danazol	< 0.01 %
DHEAS	< 0.01 %
Estriol	< 0.01 %
Estrone	< 0.01 %
Ethisterone	0.03 %
Pregnenolone	< 0.01 %
Progesterone	< 0.01 %
Testosterone	8.1 %

INTERFERENCES

An interference study was performed according to the CLSI EP07-A2 guideline.
No significant interference was observed for concentrations of up to 10 g/L Haemoglobin, 10 mg/dL Bilirubin (conjugated and unconjugated), 1500 mg/dL Triglycerides, 2.4 μg/mL Biotin, 1.2 μg/mL HAMAS and 2531 IU/mL Rheumatoid Factor.
Interferences were observed for both bilirubin conjugated and unconjugated at levels of 20 mg/dL or higher.

PRECISION
The precision study was performed according to the CLSI EP05-A2 guideline.

Repeatability

The experimental protocol used a nested components-of-variance design with 7 serum samples, 10 testing days, two lots, and two scientists per day. Each scientist ran two tests per day and two replicate measurements per run (a 10 x 2 x 2 x 2 design) for each sample.

The results were analyzed with a two-way nested ANOVA and summarized in the table below.

Sample	Mean	SD Within Run	CV Within Run	SD Between Run	CV Between Run	Total SD	CV Total
1	31.4 pg/mL	13.7 pg/mL	43.7 %	3.3 pg/mL	10.5 %	14.1 pg/mL	44.9 %*
2	144.2 pg/mL	19.3 pg/mL	13.4 %	8.5 pg/mL	5.9 %	21.0 pg/mL	14.6 %
3	817.5 pg/mL	51.7 pg/mL	6.3 %	21.1 pg/mL	2.6 %	55.8 pg/mL	6.8 %
4	429.5 pg/mL	34.5 pg/mL	8.0 %	10.8 pg/mL	2.5 %	36.8 pg/mL	8.6 %
5	586.2 pg/mL	38.8 pg/mL	6.6 %	15.5 pg/mL	2.6 %	41.8 pg/mL	7.1 %
6	1561 pg/mL	90.0 pg/mL	5.8 %	24.1 pg/mL	1.5 %	94.5 pg/mL	6.1 %
7	1287 pg/mL	71.1 pg/mL	5.5 %	18.5 pg/mL	1.4 %	73.4 pg/mL	5.7 %

Reproducibility
The reproducibility study evaluated the precision performance of the device following the experimental design model 3 x 5 x 5 (3 locations x five testing days x five replicates per day) across laboratories located in Italy, the USA, and Canada. The results were analyzed with a two-way nested ANOVA and are summarized in the table below.

Sample	Mean	Repeatability		Within Location		Reproducibility
Sample	Mean	SD	CV	SD	CV	SD	CV
QCL	129.4 pg/mL	5.5 pg/mL	4.3 %	6.5 pg/mL	5.1 %	7.5 pg/mL	5.8 %
QCH	411.8 pg/mL	14.5 pg/mL	3.5 %	18.4 pg/mL	4.5 %	19.8 pg/mL	4.8 %
1	65.4 pg/mL	4.4 pg/mL	6.7 %	5.7 pg/mL	8.8 %	10.7 pg/mL	16.4 %
2	189.7 pg/mL	8.5 pg/mL	4.5 %	17.7 pg/mL	9.3 %	33.5 pg/mL	17.7 %
3	228.2 pg/mL	8.8 pg/mL	3.9 %	15.7 pg/mL	6.9 %	30.6 pg/mL	13.4 %
4	390.4 pg/mL	12.1 pg/mL	3.1 %	31.1 pg/mL	8.0 %	38.0 pg/mL	9.7 %
5	655.8 pg/mL	18.7 pg/mL	2.8 %	38.3 pg/mL	5.8 %	63.8 pg/mL	9.7 %
6	883.2 pg/mL	26.4 pg/mL	3.0 %	55.4 pg/mL	6.3 %	128.1 pg/mL	14.5 %

LINEARITY

The linearity study was performed according to the CLSI EP06-Ed2 guideline using four human serum samples covering the range of the assay (between 226 and 2500 pg/mL).
The samples were diluted in serum samples with a low concentration of DHT (less than 50 pg/mL) at several equidistant concentration levels and up to ten percent (1:10), tested in duplicate, and the results compared to the predicted concentration. The statistical analysis shows that the assay is sufficiently linear up to a 1:10 dilution.

RECOVERY
Spiked samples were prepared by adding defined amounts of DHT (present in serum samples with a high DHT concentration) to four serum samples. The results (in pg/mL) are tabulated below:

Sample	Concentration Result	Concentration of Spiking Samples	Expected Concentration from 9:1 v/v	Recovery
1	91.3 pg/mL	–	–	–
	177.3 pg/mL	800 pg/mL	162.2 pg/mL	109.3 %
	230.2 pg/mL	1472 pg/mL	229.4 pg/mL	100.3 %
	313.8 pg/mL	2672 pg/mL	349.4 pg/mL	89.8 %
2	191.6 pg/mL	–	–	–
	261.0 pg/mL	800 pg/mL	252.5 pg/mL	103.4 %
	306.2 pg/mL	1472 pg/mL	319.7 pg/mL	95.8 %
	408.0 pg/mL	2672 pg/mL	439.7 pg/mL	92.8 %
3	379.5 pg/mL	–	–	–
	433.2 pg/mL	800 pg/mL	421.6 pg/mL	102.7 %
	499.5 pg/mL	1472 pg/mL	488.8 pg/mL	102.2 %
	573.3 pg/mL	2672 pg/mL	608.8 pg/mL	94.2 %
4	360.2 pg/mL	–	–	–
	383.2 pg/mL	800 pg/mL	404.2 pg/mL	94.8 %
	461.8 pg/mL	1472 pg/mL	471.4 pg/mL	98.0 %
	510.8 pg/mL	2672 pg/mL	591.4 pg/mL	86.4 %

COMPARATIVE STUDIES

The 5α Dihydrotestosterone (DHT) ELISA (y) was compared to a Liquid Chromatography-Tandem Mass Spectrometry DHT method (x).

The comparison of 90 serum samples yielded the following linear regression results using a Passing-Bablok fit:
- y = 0.78x + 73.8, r = 0.88

REFERENCE RANGES

Reference ranges (95%) were estimated using samples obtained from adult individuals of diverse origins. Each laboratory shall establish its range of reference values.

Cohort	n	Median	95% Reference Range
Adult Males (20 – 89 years old)	304	380 pg/mL	143 – 842 pg/mL
Adult Females (18 – 50 years old)	183	91 pg/mL	ND – 596 pg/mL
Adult Females (51 – 83 years old)	135	53 pg/mL	ND – 431 pg/mL
ND = Not detectable; lower than the LoD

Reference ranges were estimated using pediatric samples as shown below. Due to the limited sample size, a 95% reference range could not be established; the total range is provided. Each laboratory shall establish its range of reference values.

Gender	Age	n	Total Range
Male	1 – 9 years	40	ND – 85.7 pg/mL
	10 – 14 years	26	11.1 – 875.6 pg/mL
	15 – 18 years	14	70.3 – 1260.9 pg/mL
Female	2 – 9 years	40	ND – 88.9 pg/mL
	10 – 14 years	21	22.5 – 280.6 pg/mL
	15 – 18 years	19	62.6 – 760.3 pg/mL

ND = Not detectable; lower than the LoD

RECOMMENDED ASSAY LAYOUT

SYMBOLS USED

DRG Instruments GmbH

DRG Instruments GmbH, Germany Frauenbergstraße 18, 35039 Marburg

Phone: +49 (0)6421-1700 0
Fax: +49 (0)6421-1700 50
Website: www.drg-diagnostics.de

E-mail: drg@drg-diagnostics.de.

DRG International, Inc.

DRG International, Inc., USA 841 Mountain Ave., Springfield, NJ 07081

Phone: (973) 564-7555
Fax: (973) 564-7556
Website: www.drg-international.com.

E-mail: corp@drg-international.com.

Documents / Resources

DRG EIA-2330 5α Dihydrotestosterone Diagnostics [pdf] Instruction Manual
EIA-2330 5 Dihydrotestosterone Diagnostics, EIA-2330, 5 Dihydrotestosterone Diagnostics, Dihydrotestosterone Diagnostics