ELISA kit INSTRUCTION FOR USE

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1 ELISA kit INSTRUCTION FOR USE

2 INSTRUCTIONS FOR USE Other languages available at BIOHIT Total 25OH Vitamin D ELISA kit Cat.No INTENDED USE The BIOHIT Total 25OH Vitamin D ELISA is a quantitative immunoenzymatic assay for the in vitro determination of 25-hydroxyvitamin D2 and D3 (25OH-D2 and 25OH-D3) in serum to aid in the diagnosis of Vitamin D deficiency, insufficiency or intoxication. 2. BACKGROUND Vitamin D is the generic term used to designate Vitamin D2 or ergocalciferol and Vitamin D3 or cholecalciferol. Humans naturally produce Vitamin D3 when the skin is exposed to ultraviolet sun rays. Vitamin D3 and Vitamin D2 are naturally present in certain foods, added to others, and also available as dietary supplements. (1-2) In the liver, Vitamin D3 is metabolized into 25-hydroxyvitamin D3 (25OH D3, also known as calcidiol) which is the main form of Vitamin D circulating in the body. 25OH D3 is a precursor for other Vitamin D metabolites and has also a limited activity by itself. Recently it has been found that 25OH Vitamin D is also available directly from certain animal-based foods. The most active derivative is 1,25- dihydroxyvitamin D3 (also known as calcitriol), produced in the kidney by 1- hydroxylation of 25OH D3. As Vitamin D2 is metabolized in a similar way to Vitamin D3, both forms contribute to the overall Vitamin D status of an individual. This is why it is very important to measure both forms of 25OH Vitamin D equally for a correct diagnosis of Vitamin D deficiency, insufficiency or intoxication. The best indicator of Vitamin D status is the serum concentration of 25OH Vitamin D. It reflects vitamin D produced both in the skin and that obtained from food and supplements and has a reasonably long circulating half-life of 15 days. (1-8) 25OH Vitamin D stimulates the intestinal absorption of both calcium and phosphorus, as well as affects bone resorption and mineralization. Vitamin D deficiency is an important risk factor for rickets, osteomalacia and senile osteoporosis. Vitamin D has been found to have several other roles in the body, including modulation of cell growth, neuromuscular and immune function, and reduction of inflammation. An association between cognitive impairment, dementia, and vitamin D deficiency has also been confirmed. Vitamin D may also play a role in cancer and pregnancy outcomes. The measurement of both 25OH Vitamin D forms is also required to determine the cause of abnormal serum calcium concentrations in patients. Vitamin D intoxication has been shown to cause kidney and tissue damages. (1-4, 9-11). 1

3 3. PRINCIPLE OF THE TEST The BIOHIT Total 25OH Vitamin D ELISA assay is a competitive solid phase enzyme linked immunosorbent assay performed on microtiterplates. During the first 2 hour incubation step, at room temperature (RT), 25OH Vitamin D (D2 and D3) present in calibrators, controls and samples is dissociated from serum proteins and becomes bound to a specific monoclonal antibody. After washing, a fixed amount of biotin-labeled 25OH vitamin D together with horseradish peroxidase (HRP) is added. The labeled 25OH vitamin D competes with unlabeled 25OH Vi- tamin D2 and D3 present on the binding sites of the specific monoclonal antibody. After incubating for 30 minutes at RT, the microtiterplate is washed to stop the competition reaction. The Chromogenic solution (TMB) is added and incubated for 15 minutes. The reaction is stopped with the addition of Stop Solution and the signal from the microtiterplate is then measured at the appropriate wavelength. The amount of substrate turnover is determined colorimetrically by measuring the absorbance, which is inversely proportional to the total 25OH Vitamin D (D2 and D3) concentration. A calibration curve is plotted and the total 25OH Vitamin D (D2 and D3) concentrations of the samples are determined by dose interpolation from the calibration curve. 4. WARNINGS AND PRECAUTIONS For in vitro diagnostic use only. The human blood components included in this kit have been tested by European approved and/or FDA approved methods and found negative for anti-hiv antibodies, anti-hcv antibodies and Hepatitis B surface antigen (HBsAg). Nevertheless, all these materials should be regarded and handled as potentially infectious. All animal products and derivatives have been collected from healthy animals. Bovine components originate from countries where BSE has not been reported. Nevertheless, components containing animal substances should be treated as potentially infectious. Avoid any skin contact with all reagents. Stop Solution contains HCl. In case of contact, wash thoroughly with water. Do not smoke, drink, eat or apply cosmetics in the working area. Do not pipette by mouth. Use protective clothing and disposable gloves. 5. TRACEABILITY OF VALUES The test is calibrated against the ID-LC/MS-MS Reference Measurement Pro- cedure (Ghent method) (12-13) as approved by the Vitamin D Standardization Program (VDSP) established by the National Institutes of Health (NIH) Office of Dietary Supplements (ODS). 2

4 6. KIT CONTENTS 6.1 MICROPLATE 12 8 well microtiter strips (96 break-apart wells) coated with monoclonal anti- bodies for 25OH Vitamin D2 and D3. Packed in a re-sealable pouch with desiccant. Color code: blue. Ready to use. 6.2 CALIBRATOR 0 1 vial of lyophilized biological material with gentamycin and Proclin. Color code yellow. Reconstitute the Calibrator by adding 2 ml of distilled water. Note: Use Calibrator 0 for dilution of samples with values above the highest calibrator. 6.3 CALIBRATORS vials of lyophilized calibrators 1-5 (see exact values on vial labels) in horse serum with gentamycin and Proclin. Color code yellow. The exact 25OHD concentration of the calibrators is labelled on the vials. Reconstitute the calibrators by adding 1 ml of distilled water into each vial. 6.4 CONTROLS 2 vials of lyophilized Controls (N = 2) in human serum with Proclin. Color code silver. Reconstitute by adding 1 ml distilled water to each vial. 6.5 INCUBATION BUFFER 1 bottle (20 ml) of Incubation Buffer with casein and Proclin. Color code green. Ready to use. 6.6 CONJUGATE BUFFER 1 bottle (30 ml) of Conjugate Buffer with casein and Proclin. Color code red. Ready to use. 6.7 CONCENTRATED CONJUGATE 1 vial (0.3 ml) of 25OH Vitamin D Concentrated Conjugate. Color code blue. Dilute 100x with conjugate buffer, as described in the table below. 6.8 CONCENTRATED HRP 1 vial (0.2 ml) of concentrated HRP. Color code yellow. Dilute 200x with conjugate buffer, as described in table below. Working solution of HRP conjugate: The HRP conjugate working solution is to be prepared during the first 2h incubation and at minimum 1h 45 min before its use! Prepare an adequate volume of working HRP conjugate solution by mixing concentrated conjugate, concentrated HRP and conjugate buffer according to the number of used strips, as indicated in the below table. For example for 6 strips (48 wells): 100µl of concentrated conjugate and 50 µl of concentrated HRP to 10 ml of conjugate buffer. Use a vortex to homogenize. Until used, keep the working HRP conjugate at room temperature and avoid direct sunlight or use a brown glass vial for its preparation. The preparation of working HRP conjugate is not stable and must be discarded if not used during the same working day. 3

5 No. of strips Volume of Concentrated Conjugate (µl) Volume of Concentrated HRP (µl) Volume of Conjugate Buffer (ml) WASH SOLUTION CONCENTRATE 1 bottle (10 ml) of Wash solution (TRIS-HCl) concentrate. Color code brown. To prepare Working Wash Solution: Dilute 200x with distilled water by adding 199 volumes of distilled water to 1 volume of Wash Solution (200x). Use a magnetic stirrer to homogenize. Discard unused Working Wash solution at the end of the day CHROMOGENIC SOLUTION TMB 1 bottle (12 ml) of Chromogenic solution TMB (Tetramethylbenzydine). Color code brown. Ready to use STOP SOLUTION 1 bottle (12 ml) of HCl 1M. Ready to use INSTRUCTIONS FOR USE Instructions for use in English. Other languages: 7. MATERIALS REQUIRED BUT NOT PROVIDED Distilled water Pipettes for delivery of: 50 µl, 100 µl, 150 µl, 200µl and 1 ml (the use of accurate pipettes with disposable plastic tips is recommended) Vortex mixer Magnetic stirrer Plate shaker (300 to 700 rpm) Washer for microtiterplates Microtiter plate reader capable of reading at 450 nm and 630 or 650 nm (bi-chromatic reading) 4

6 8. STORAGE AND STABILITY Before opening or reconstitution, all kits components are stable until the expiry date indicated on the label, if kept at 2-8 C. After reconstitution, calibrators and controls are stable for eight weeks at 2-8 C. For longer storage periods, aliquots should be made and kept at 20 C for maximum 4 months. Avoid subsequent freeze-thaw cycles. Freshly prepared Working Wash solution should be used on the same day. Alterations in physical appearance of kit reagents may indicate instability or deterioration. 9. SPECIMEN COLLECTION AND PREPARATION This kit is suitable for serum samples. Serum samples should be kept at 2-8 C. Temporary (<24h) storage at RT is acceptable. If the test is not run within 3 days, storage at -20 C is recommended for serum samples. Avoid subsequent freeze-thaw cycles. 10. TEST PROCEDURE 10.1 HANDLING NOTES Do not use the kit or components beyond the expiry date. Do not mix materials from different kit lots. Bring all the reagents to room temperature prior to use. Thoroughly mix all reagents and samples by gentle agitation or swirling. Perform calibrators, controls and samples in duplicate. Vertical alignment is recommended. Use a clean plastic container to prepare the Wash Solution. In order to avoid cross-contamination, use a clean disposable pipette tip for the addition of each reagent and sample. High precision pipettes or automated pipetting equipment will improve the precision. To avoid drift, the time between pipetting of the first calibrator and the last sample must be limited to 20 min, as described in section Prepare a calibration curve for each run. Do not use data from previous runs. Dispense the Chromogenic Solution within 15 minutes following the washing of the microtiterplate. During incubation with Chromogenic Solution, avoid direct sunlight on the microtiterplate. Samples suspected to contain concentrations above the highest calibrator should be diluted in calibrator 0 for the assay. Hemolyzed samples should not be used. 5

7 10.2 ASSAY PROTOCOL 1. Reconstitute calibrators and controls with distilled water as described in section Select the required number of strips for the run. The unused strips should be resealed in the bag with a desiccant and stored at 2-8 C. 3. Secure the strips into the holding frame. 4. Pipette 50 µl of each Calibrator, Control and Sample into the appropriate wells. Note: Use Calibrator 0 for dilution of samples with values expected to be above the highest calibrator. 5. Pipette 150 µl of Incubation Buffer into the wells. 6. Incubate for 2 hours at room temperature, on a plate shaker ( rpm). Prepare the Working HRP conjugate solution during the incubation and minimum 1h 45 minutes before its use. 7. Aspirate the liquid from each well. Wash the plate 3 times by dispensing 350 µl of Wash Solution into each well and aspirating the content of each well. 8. Pipette 200 µl of the working HRP conjugate solution into each well. 9. Incubate the microtiterplate for 30 minutes at room temperature, on a plate shaker ( rpm). 10. Aspirate the liquid from each well. Wash the plate 3 times by dispensing 0.35 ml of Wash Solution into each well and aspirating the content of each well. 11. Pipette 100 µl of the Chromogenic solution into each well within 15 minutes following the washing step. 12. Incubate the microtiterplate for 15 minutes at room temperature, on a plate shaker (300 to 700 rpm), avoid direct sunlight. 13. Pipette 100 µl of Stop Solution into each well. 14. Read the absorbance at 450 nm (reference filter 630 nm or 650 nm) within 1 hour and calculate the results as described in section 11. 6

8 11. CALCULATION OF RESULTS 1. Calculate the mean of duplicate determinations. 2. Calculate for each calibrator, control and sample: 3. Using either linear-linear or semi-logarithmic graph paper, plot the (B/B0(%)) values for each calibrator point as a function of the 25OH Vitamin D concentration of each calibrator point. Reject obvious outliers. 4. Computer assisted methods can also be used to construct the calibration curve. If automatic result processing is used, a 4-parameter logistic function curve fitting is recommended. 5. By interpolation of the sample (B/B0 (%)) values, determine the 25OH Vita- min D concentrations of the samples from the calibration curve. 12. TYPICAL DATA The following data are for illustration only and should never be used instead of the real time calibration curve. 25OH Vitamin D ELISA OD units 0 ng/ml ng/ml 2.39 Calibrator 15.0 ng/ml ng/ml ng/ml ng/ml 0.21 Note: 1 ng/ml = 2.5 pmol/ml 13. INTERNAL QUALITY CONTROL If the results obtained for Control 1 and/or Control 2 are not within the range specified on the vial label, the results cannot be used unless a satisfactory explanation for the discrepancy has been given. If desirable, each laboratory can make its own pools of control samples, which should be kept frozen in aliquots. Controls which contain azide will interfere with the enzymatic reaction and cannot be used. Acceptance criteria for the difference between the duplicate results of the samples should rely on good laboratory practices. It is recommended that Controls be routinely assayed as unknown samples to measure assay variability. The performance of the assay should be monitored with quality control charts of the controls. It is good practice to visually check the curve fit selected by the computer. 7

9 14. REFERENCE VALUES The Clinical Practice guideline from the Endocrine Society defines Vitamin D deficiency as a 25(OH)D level below 20 ng/ml and vitamin D insufficiency as 25(OH)D ng/ml (3). Serum concentrations consistently above 150 or 200 ng/ml are considered potentially toxic (1, 9, 15) based on which a wider safety limit of 100 ng/ml has been suggested (15). However, adverse health effects have possibly been linked to much lower concentrations of 25(OH)D, and it has been suggested that concentrations above ng/ml should be avoided (2). Factors such as dietary intake, demographics and season are known to affect the normal levels of 25(OH) Vitamin D3 (1, 5, 16). Each laboratory should establish its own range based on their local population and possible recommendations by national health authorities. There is still some debate regarding the optimal levels of vitamin D in serum (1-3, 5, 16). A suggestion, based on the Endocrine Society guideline (3), and recent literature (16-18) for defining 25 OH vitamin D levels in serum is presented below. Level Deficiency Insufficiency Sufficiency Potential toxicity Note: 1 ng/ml = 2.5 nmol/l ng/ml <20 ng/ml ng/ml >30 ng/l >100 ng/ml Reference ranges have been established based on 150 apparently healthy individuals. The individual patient serum samples used were obtained from a certified commercial source and were collected from an FDA Licensed Donor Center with informed consent. 50 samples were from Northern US (Pennsylvania), 50 samples were from Central US (Tennessee), and 50 samples were from Southern US (Florida). Samples were collected in the winter months (January - March), were between the ages of years old and included both light skin and dark skin population. The donors from whom the samples were collected were not taking vitamin D supplements, had no family history of parathyroid, or calcium regulatory disease, had no history or Kidney, Liver, Parathyroid, Calcium related disease or bariatric surgery, and were not taking any medications known to affect absorption or catabolism of Vitamin D. The following table is the summary or results: Florida Tennessee Pennsylvania Overall Highest conc. (ng/ml) Lowest conc. (ng/ml) Median conc. (ng/ml) Only central 95% (2.5% %) of the results observed were used. 8

10 15. LIMITATIONS OF THE TEST 1. The test is an aid in the diagnosis and is to be used in conjunction with clinical findings. 2. The performance of this assay has not been established in a pediatric population. 3. Hemolyzed samples should not be used. 16. PERFORMANCE AND LIMITATIONS 16.1 LIMITS OF DETECTION The Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were determined in accordance with the CLSI guideline EP17-A. (14) The LoB was calculated by measuring the blank several times and calculating the 95th percentile of the distribution of the test values. The LoB was calculated to be 1.69 ng/ml. The LoD was calculated as described in the guideline. The LoD was calculated to be 2.81 ng/ml. The LoQ was calculated by testing 5 samples of low value 14 times in different test. The LoQ was calculated to be 4.39 ng/ml with CV of 20% ANALYTICAL SPECIFICITY Cross-reactivity of the BIOHIT Total 25OH Vitamin D ELISA assay was determined by testing sera with spiked and unspiked cross-reactants. The results are summarized in the following table: Compound and Concentration % Cross-reaction 25OH-Vitamin D3 at 10 ng/ml OH-Vitamin D2 at 10 ng/ml 86 1,25(OH) 2 -Vitamin D3 at 200 ng/ml 20 1,25(OH) 2 -Vitamin D2 at 690 ng/ml 1.9 Vitamin D3 at 200 ng/ml 2.9 Vitamin D2 at 200 ng/ml ,25(OH) 2 -Vitamin D3 at 20 ng/ml >100 25,26(OH) 2 -Vitamin D3 at 4 ng/ml >100 3-epi-25OH-Vitamin D3 at 20 µg/ml 0.1 9

11 16.3 INTERFERENCE The effects of potential interfering substances were evaluated. Different levels of hemoglobin, triglyceride, Vitamin C, bilirubin conjugated and unconjugated, biotin and Zemplar in serum samples were tested on samples with different 25OH Vitamin D concentrations. The acceptance criteria were to have interference of less than 10%. The tested substances did not affect the performance of the BIOHIT Total 25 OH Vitamin D ELISA assay. Substance Conc. of interferent tested (mg/dl) Conc. of 25 OH vitamin D (ng/ml) Mean % variation Hemoglobin 250 / / 29.3 / % Bilirubin conjugated 50 / / 21.5 / % Bilirubin unconjugated 50 / / 29.3 / % Triglyceride 7.5 / 125 / 250 / / 29.3 / % Vitamin C 1 / 10 / / 21.5 / % Biotin 0.2 / 2 / / 19.8 / % Zemplar / / / % 16.4 PRECISION The assay precision was calculated by running samples for a span of at least 20 days using 3 different lots. The results are summarized in the table below: INTRA-ASSAY INTER-ASSAY Sample N <X> ± SD (ng/ml) CV (%) Sample N X> ± SD (ng/ml) C.V. (%) A ± A ± B ± B ± C ± C ± D ± D ± SD: Standard Deviation, CV: Coefficient of variation 10

12 16.5 REPRODUCIBILITY The reproducibility of the assay was done by testing three samples in duplicate for five days, twice a day, at three sites with two technicians per site. The mean results are summarized in the table below: Sample N ng/ml Within- Run Between- Run Between- Day Between- Tech Between- Site Total SD CV % % % % % % SD CV % % % % % % SD CV % % % % % % 16.6 ACCURACY Recovery was assessed by adding different levels of 25OH Vitamin D to samples. The results are summarized in the table below: RECOVERY TEST Added 25OH-Vit.D3 (ng/ml) Recovery (%) Added 25OH-Vit.D2 (ng/ml) Recovery (%)

13 Two samples with concentrations distributed throughout the measurable range were tested at equidistant dilutions to determine the linear range of the assay. A linear regression analysis was performed. The results are summarized in the following table: Sample 1 Sample Dilution Theoretical Concentration (ng/ml) Measured Concentration (ng/ml) Slope Y- Intercept R2 Recovery (%) 1/ / / , / / Sample 2 Sample Dilution Theoretical Concentration (ng/ml) Measured Concentration (ng/ml) Slope Y- Intercept R2 Recovery (%) 1/ / / / / The linear range of the assay was found to be from 7.7 ng/ml to ng/ml TIME DELAY Results for the time delay test between the dispensing of the last calibrator and sample are shown in the following table: TIME DELAY 0 min (ng/ml) 10 min (ng/ml) 20 min (ng/ml) Sample Sample Assay results remain accurate even when incubation buffer is dispensed 10 and 20 minutes after the calibrator has been added in the coated wells. 12

14 16.8 METHOD COMPARISON The performance of the BIOHIT Total 25OH Vitamin D ELISA test was determined by conducting a correlation study tested at three different sites using a total of 356 samples. The samples were tested on both the BIOHIT Total 25OH Vitamin D ELISA test and a commercially available 25OH Vitamin D ELISA test. The results ranged from 8.0 ng/ml to ng/ml, the correlation coefficient between the two methods was 0.917, with the 95% confidence interval of 87.6% to 93.6%, a slope of and the y-intercept of The following graph summarizes the results: 17. DATE OF ISSUE WARRANTY Biohit shall remedy all defects discovered in any Product (the Defective Product ) that result from unsuitable materials or negligent workmanship and which prevent the mechanical functioning or intended use of the Products including, but not limited to, the functions specified in Biohit s specifications for the Products. ANY WARRANTY WILL, HOWEVER, BE DEEMED AS VOID IF FAULT IS FOUND TO HAVE BEEN CAUSED BY MALTREATMENT, MISUSE, ACCIDENTAL DAMAGE, INCORRECT STORAGE OR USE OF THE PRODUCTS FOR OPERATIONS OUTSIDE THEIR SPECIFIED LIMITATIONS OR OUTSIDE THEIR SPECIFICATIONS, CONTRARY TO THE INSTRUCTIONS GIVEN IN THE INSTRUCTION MANUAL. The period of this warranty is defined in the instruction manual of the Products and will commence from the date the relevant Product is shipped by Biohit. This Biohit Diagnostic kit has been manufactured according to ISO 9001 / ISO quality management protocols. In case of interpretation disputes the English text applies. 19. ORDERING INFORMATION BIOHIT Total 25OH Vitamin D Elisa kit Cat. No

15 20. BIBLIOGRAPHY 1. HOLICK MF. Vitamin D deficiency. N Engl J Med 2007; 357: HOLICK MF, BINKLEY NC, BISCHOFF-FERRARI HA, GORDON CM, HANLEY DA, HEANEY RP, MURAD MH, WEAVER CM. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011; 6(7): ROSS AC, TAYLOR CL, YAKTINE AL, DEL VALLE HB, eds. Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academy Press (2010). 4. HOLICK MF Vitamin D Status: Measurement, Interpretation, and Clinical Application. Ann Epidemiol 2009; 19: GRÖBER U, SPITZ J, REICHRATH J, KISTERS K, HOLICK MF. Vitamin D Update 2013: From rickets prophylaxis to general preventive healthcare. Dermatoendocrinol 2013; 5(3): ZERWEKH JE. Blood biomarkers of Vitamin D status. Am J Clin Nutr 2008; 87(suppl):1087S-91S. 7. TAYLOR CL, PATTERSON KY, ROSELAND JM, WISE SA, MERKEL JM, PEHRSSON PR, YETLEY EA. Including food 25-hydroxyvitamin D in intake estimates may reduce the discrepancy between dietary and serum measures of vitamin D status. J Nutr 2014; 144: HEANEY RP, ARMAS LA, FRENCH C. All-source basal vitamin D inputs are greater than previously thought and cutaneous inputs are smaller. J Nutr 2013; 143: HOLICK MF. Resurrection of Vitamin D deficiency and rickets. J Clin Invest 2006; 116: CHRISTAKOS S, HEWISON M, GARDNER DG, WAGNER CL, SERGEEV IN, RUTTEN E, PITTAS AG, BOLAND R, FERRUCCI L, BIKLE DD. Vitamin D: beyond bone. Ann NY Acad Sci 2013; 1287 (2013) SCHLÖGL M, HOLICK MF.Vitamin D and neurocognitive function. Clin Interv Aging 2014; 9: STEPMAN HC, VANDERROOST A, VAN UYTFANGHE K, THIENPONT LM. Candidate Reference Measurement Procedures for Serum 25-Hydroxyvitamin D3 and 25-Hydroxyvitamin D2 by Using Isotope-Dilution Liquid Chromatography Tandem Mass Spectrometry (ID- LC/ MS-MS). Clin Chem 2011; 57(3): THIENPONT LM, STEPMAN HCM, VESPER HW. Standardization of measurements of 25- Hydroxyvitamin D3 and D2. Scand. J Clin Lab Inves 2012; 72(Suppl. 243): DANIEL W, THOLEN MS. Clinical and laboratory standards Institute (CLSI) (2004). Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. CLSI document EP17-A. 15. JONES G. Pharmacokinetics of vitamin D toxicity. Am J Clin Nutr 2008; 88:582S-6S. 16. HEANEY RP. Health is better at serum 25(OH) D above 30ng/mL. J Steroid Biochem Mol Biol 2013; 136: VIETH R. Why the minimum desirable serum 25-hydroxyvitamin D level should be 75 nmol/l (30 ng/ml). Best Pract Res Clin Endocrinol Metab 2011; 25(4): DAWSON-HUGHES B, HEANEY RP, HOLICK MF, LIPS P, MEUNIER PJ, VIETH R. Estimates of optimal vitamin D status. Osteoporos Int 2005; 16(7):

16 21. SYMBOLS For in vitro diagnostic use Catalogue number Batch code 96 tests Caution Consult instructions for use Protect from Sunlight Use by Store at 2-8 C Do not re-use 22. Short Outline of the Procedure Calibrators (0-5) Controls, Samples Incubation Buffer CALIBRATORS (µl) SAMPLE(S), CONTROLS (µl) Incubate for 2 hours at RT with shaking. Prepare the working HRP conjugate during the incubation and min. 1h 45 minutes before use. Wash 3 x with 350 µl of Wash Solution. Working HRP Conjugate Incubate for 30 minutes at RT with shaking. Wash 3 times with 350 µl of Wash Solution. Chromogenic Solution Incubate for 15 min at RT with shaking. Stop Solution Measure absorbance at 450 nm (versus 630 or 650 nm). Headquarters BIOHIT OYJ Laippatie Helsinki, Finland Tel: Fax: info@biohit.fi version

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