Kalsitonin PDF

DRG® Calcitonin ELISA (EIA-3648)
IVD
Revised 4 Nov. 2010 rm (Vers. 4.1)
Please use only the valid version of the package insert provided with the kit.
Name and Intended Use

The Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum.
The test is for in vitro diagnostic use only.
Summary and Explanation

Calcitonin, a 32-amino-acid polypeptide, is secreted primarily by the thyroidal parafollicular C-cells. Its main
biological effect is to inhibit osteoclastic bone resorption. This property has led to Calcitonin’s use for disorders
characterized by increased resorption such as Paget’s disease, for some patients with osteoporosis.
Clinical Relevance
The most prominent clinical syndrome associated with a disordered hypersecretion of Calcitonin is medullary
carcinoma of the thyroid (MTC). MTC is a tumor of the Calcitonin producing C-cells of the thyroid gland.
Although MTC is rare, comprising 5 - 10% of all thyroid cancer, it is often fatal. It may occur sporadically or in a
familial form that is transmitted as an autosomal dominant trait. MTC has great clinical importance because of its
familial distribution. Further, it leant itself to be diagnosed early by serum Calcitonin and total cure for early sub-
clinical disease is possible[1]. This is frequently associated with other clinical features and it has good potential
for cure with surgery. Although a rare tumor, it can occur in a familial pattern[1,3,4] as a Type II multiple
endocrine neoplasia. These tumors usually produce diagnostically elevated serum concentrations of Calcitonin.
Therefore, the immunoassay for Calcitonin in serum can be used to diagnose the presence of MTC with an
exceptional degree of accuracy and specificity. In the small but increasing percentage of patients, however, basal
hormone levels are indistinguishable from normal[1]. Some of these subjects represent the early stages of C-cell
neoplasia or hyperplasia that are most amenable to surgical cure. To identify these patients with early disease,
provocative tests for Calcitonin secretion is necessary to preclude false negatives if only basal Calcitonin
determination are performed. Most tumors respond with increased Calcitonin level to the administration of either
calcium[5] or pentagastrin[6] or their combination[7], but either agent can still give misleading results. Therefore,
in cases with clinical manifestations, both agents should be considered for diagnostic testing. Further, Calcitonin
measurements can also be used to monitor the efficacy of therapy in patients with Calcitonin producing tumors.
It has been reported[8] that multiple forms of immunoreactive calcitonin are found in either normal subjects or
patients with MTC. These various forms of calcitonin have molecular weights varying from 3,400 (monomeric)
up to 70,000 Dalton (polymeric).
Neoplastic disorders of other neuroendocrine cells can also elevate Calcitonin. The best example is small cell
lung cancer. Other tumors such as carcinoids and islet cell tumors of the pancreas can also result in elevated
serum Calcitonin.
Increases in serum Calcitonin has also been noted in both acute and chronic renal failure, hypercalciuria and
hypercalcemia.
DRG International Inc., USA 1

Fax: (908) 233-0758  E-mail: corp@drg-international.com  Web: www.drg-international.com
IVD
Principle of the Test

The DRG Calcitonin Immunoassay is a two-site ELISA [Enzyme-Linked ImmunoSorbent Assay] for the
measurement of the biologically intact 32 amino acid chain of Calcitonin. It utilizes two different mouse
monoclonal antibodies to human calcitonin specific for well-defined regions on the calcitonin molecule. One
antibody binds only to Calcitonin 11-23 and this antibody is biotinylated. The other antibody binds only to
Calcitonin 21-32 and this antibody is labeled with horseradish peroxidase [HRP] for detection.
Streptavidin Biotinylated Intact HRP conjugated

  
Well Anti-Calcitonin (11-23) Calcitonin Anti-Calcitonin (21-32)
In this assay, calibrators, controls, or patient samples are simultaneously incubated with the enzyme labeled
antibody and a biotin coupled antibody in a streptavidin-coated microplate well. Thus the calcitonin in the sample
is “sandwiched” between these two antibodies. At the end of the assay incubation, the microwell is washed to
remove unbound components and the enzyme bound to the solid phase is incubated with the substrate,
tetramethylbenzidine (TMB). An acidic stopping solution is then added to stop the reaction and converts the
color to yellow. The intensity of the yellow color is directly proportional to the concentration of calcitonin in the
sample. A dose response curve of absorbance unit vs. concentration is generated using results obtained from the
calibrators. Concentrations of calcitonin present in the controls and patient samples are determined directly from
this curve.

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Kit Components
Kit Components Description Quantity
RGT 1 = Reagent 1 Biotinylated Calcitonin Antibody 1 x 7.0 mL
RGT 2 = Reagent 2 Peroxidase (Enzyme) labeled Calcitonin Antibody 1 x 7.0 mL
RGT 3 = Reagent 3 Reconstitution Solution containing EDTA 1 x 10 mL
RGT A = Reagent A ELISA Wash Concentrate [Saline with surfactant] 1 x 30 mL
RGT B = Reagent B TMB Substrate [tetramethylbenzidine] 1 x 20 mL
SOLN = Stopping
ELISA Stop Solution [1 N sulfuric acid] 1 x 20 mL
Solution
PLA = Microplate One holder with Streptavidin Coated Strips. 12 x 8-well strips
CAL = Calibrators Lyophilized synthetic h-Calcitonin. 1 x 2 mL for the
A: 0 pg/mL Lyophilized Zero calibrator [BSA solution]. zero calibrator
B – F: Refer to vial All other calibrators consist of synthetic h-Calcitonin
labels for exact (1-32) in BSA solution, calibrated to WHO 2nd IS 1 x 1 mL for all
concentrations 89/620 other calibrators
CTRL = Controls 1 & 2 Lyophilized. 1 x 1 mL
Refer to vial labels
2 Levels. Synthetic h-Calcitonin (1-32) in BSA solution. per level
for exact ranges
Materials required but not supplied

 Microplate reader capable of measuring absorbance at wavelengths of 450 nm and 405 nm.
 Microplate washer [if washer is unavailable, manual washing may be acceptable].
 Precision Pipettors to deliver 50, 100 and 150 µL.
 (Optional): A multi-channel dispenser or a repeating dispenser for 50, 100 and 150 µL.
Warnings and Precautions for Users

Although the reagents provided in this kit have been specifically designed to contain no human blood
components, the human patient samples, which might be positive for HBsAg, HBcAg or HIV antibodies, must be
treated as potentially infectious biohazard. Common precautions in handling should be exercised, as applied to
any untested patient sample.
Stopping Solution consists of 1 N Sulfuric Acid. This is a strong acid. Although diluted, it still must be handled
with care. It can cause burns and should be handled with gloves and eye protection, with appropriate protective
clothing. Any spill should be wiped immediately with copious quantities of water. Do not breath vapor and avoid
inhalation.

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Sample Collection and Storage
The determination of Calcitonin should be performed with serum. To assay the specimen in duplicate, 200 µL of
serum is required. Collect whole blood without anticoagulant. After allowing blood to clot, the serum should be
promptly separated, preferably in a refrigerated centrifuge, and stored at –20°C or lower. Avoid grossly
hemolyzed or grossly lipemic samples.
Reagent Preparation and Storage

Store all kit components at 2-8 °C except Wash Concentrate and Stop Solution upon receipt prior to use
1. All reagents except the calibrators, kit controls and the Wash Concentrate are ready-to-use. Store all reagents
at 2-8°C, except the Wash Concentrate, which should be kept at room temperature until dilution to avoid
precipitation.
2. Reconstitute Calibrator A (Zero standard) with 2.0 mL distilled or deionized water and mix.
For each of the non-zero calibrators (Calibrator B through F) and kit controls 1 and 2, reconstitute each vial
with 1.0 mL of Reagent 3 (Reconstitution Solution) and mix. Allow the vials to stand for 10 minutes and
then mix thoroughly by gentle inversion to insure complete reconstitution. Use the calibrators and controls
as soon as possible upon reconstitution. Freeze (-20°C) the remaining calibrators and controls as soon
as possible after use in a non-self-defrosting freezer.
Standards and controls are stable at –20°C for 6 weeks after reconstitution with up to 3 freeze thaw cycles
when handled as recommended in “Procedural Notes” section.
3. ELISA Reagent A: Wash Concentrate:
Mix contents of wash concentrate thoroughly. If precipitate is present in the Wash Concentrate due to storage
at lower temperature such as 4°C, dissolve by placing the vial in a 37°C water bath or oven with swirling or
stirring. Add wash concentrate (30 mL) to 570 mL of distilled or deionized water and mix.
The diluted working wash solution is stable for 90 days when stored at room temperature.
Assay Procedure
1. Place sufficient Streptavidin Coated Strips in a holder to run all the six (6) calibrators, A - F of the
Calcitonin CALIBRATORS [Exact concentration is stated on the vial label], Quality Control Sera and
patient samples.
2. Pipet 100 µL of sample into the designated or mapped well. Freeze (-20°C) the remaining calibrators and
controls as soon as possible after use, in a non-self-defrosting freezer.
3. Add or dispense 50 µL of Reagent 1 (Biotinylated Antibody) into each of the wells which already contain the
sample.
4. Add or dispense 50 µL of Reagent 2 (Enzyme Labeled Antibody) into each of the same wells.
5. Cover the microplate(s) with aluminum foil or a tray to avoid exposure to light, and place it on an orbital
shaker or rotator set at 170 ± 10 rpm for 4 hours ± 30 minutes at room temperature (22-28°C).
6. First aspirate the fluid completely and then wash/aspirate each well five (5) times with the Working Wash
Solution (prepared from Reagent A), using an automatic microplate washer. The wash solution volume
should be set to dispense 0.35 mL into each well.
7. Add or dispense 150 µL of the ELISA Reagent B (TMB Substrate) into each of the wells.
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8. With appropriate cover to avoid light exposure, place the microplate(s) on an orbital shaker or rotator set at
170 ± 10 rpm for 30 ± 5 minutes at room temperature (22-28°C).
9. Add or dispense 100 µL of the Stopping Solution into each of the wells. Mix gently.
10. Read the absorbance of the solution in the wells within 10 minutes, using a microplate reader set to 450 nm
against 250 µL of distilled or deionized water. Read the plate again with the reader set to 405 nm against
distilled or deionized water.
Note: The second reading is designed to extend the analytical validity of the calibration curve to the value
represented by the highest calibrator, which is approximately 1,000 pg/mL. Hence, patient samples with
calcitonin > 300 pg/mL can be quantified against a calibration curve consisting of the readings all the way up
to the concentration equivalent to the highest calibrator using the 405 nm reading, away from the wavelength
of maximum absorbance. In general, patient and control samples should be read using the 450 nm for
calcitonin concentrations up to 300 pg/mL. Calcitonin concentrations above 300 pg/mL should be
interpolated using the 405-nm reading.
11. By using the final absorbance values obtained in the previous step, construct a calibration curve via cubic
spline, 4 parameter logistics, or point-to-point interpolation to quantify the concentration of the calcitonin.
Procedural Notes
 Calcitonin 1-32 is a very labile molecule. Set up the assay immediately upon the reconstitution or the
thawing of all calibrators, controls, and patient samples.
 It is recommended that all calibrators, controls, and patient samples are assayed in duplicate. The average
absorbance units of duplicate sets should then be used for reduction of data and the calculation of results.
 The samples should be pipetted into the well with minimum amount of air-bubble. To achieve this, “reverse
pipet” described in the package insert of the manufacturers of Pipettors is recommended.
 Patient samples with values greater than the highest calibrator (Calibrator F), which is approximately
1,000 pg/mL (see exact concentration on vial label), may be diluted with Calibrator A (Zero Calibrator) and
reassayed. Multiply the result by the dilution factor.
 Reagents from different lot numbers must not be interchanged.
 If preferred, mix in equal volumes, in sufficient quantities for the assay, Reagent 1 (Biotinylated Antibody)
and Reagent 2 (Enzyme Labeled Antibody) in a clean amber bottle. The combined reagent is stable for seven
(7) days when stored at 4°C. Then use 100 µL of the mixed antibody into each well. This alternative method
should replace Step (3) and (4), to be followed with the incubation with orbital shaker.
 When mixing avoid splashing of reagents from wells. This will affect assay precision and accuracy.
Calculation of Results
Manuel Method
1. For the 450 nm readings, construct a dose response curve (calibration curve) using the first five calibrators
provided, i.e. Calibrators A, B, C, D and E. For the 405 nm readings, construct a second dose response curve
using the three calibrators with the highest concentrations, i.e. Calibrators D, E and F.

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2. Assign the concentration for each calibrator stated on the vial in pg/mL. Plot the data from the calibration
curve on linear graph paper with the concentration on the X-axis and the corresponding A.U. on the Y-axis.
3. Draw a straight line between 2 adjacent points. This mathematical algorithm is commonly known as the
"point-to-point" calculation. Obtain the concentration of the sample by locating the absorbance unit on the
Y-axis and finding the corresponding concentration value on the X-axis. Patient and control samples should
be read using the 450 nm for Calcitonin concentrations up to 300 pg/mL. Calcitonin concentrations above
300 pg/mL should be interpolated using the 405 nm reading.
Automated Method
Computer programs using cubic spline or 4 PL [4 Parameter Logistics] or Point-to-Point can generally give a
good fit.
Sample Data at 450 nm [raw A.U. readout against distilled or deionized water]
Microplate Well 1st Reading 2nd Reading Average Calcitonin Calcitonin
Absorbance Absorbance Absorbance pg/mL pg/mL –
Unit Unit Unit Result to
report
Calibrator A 0.008 0.009 0.0085 0
Calibrator B 0.059 0.064 0.0615 10
Calibrator C 0.186 0.194 0.190 30
Calibrator D 0.578 0.602 0.590 100
Calibrator E 1.900 1.882 1.891 300
Control 1 0.127 0.122 0.125 20.6 20.6
Control 2 2.554 2.565 2.560 > 300 *
Patient Sample 1 0.034 0.040 0.037 4.7 4.7
Patient Sample 2 0.104 0.098 0.101 16.3 16.3
Patient Sample 3 0.397 0.411 0.404 68.7 68.7
Patient Sample 4 2.195 2.173 2.184 > 300 *
* Because the concentration readout is > 300 pg/mL, it is recommended to use the data obtained at 405 nm as
shown in Sample Data at 405 nm in the table below.

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Sample Data at 405 nm [raw A.U. readout against distilled or deionized water]
Microplate Well 1st Reading 2nd Reading Average Calcitonin p Calcitonin
Absorbance Absorbance Absorbance g/mL pg/mL –
Unit Unit Unit Result to
report
Calibrator A 0.005 0.005 0.005 0
Calibrator D 0.187 0.198 0.193 100
Calibrator E 0.602 0.597 0.599 300
Calibrator F 1.898 1.910 1.904 1000
Control 1 0.045 0.044 0.045 < 300 ¶
Control 2 0.814 0.816 .815 403 403
Patient Sample 1 0.016 0.020 0.018 < 300 ¶
Patient Sample 2 0.039 0.035 0.037 < 300 ¶
Patient Sample 3 0.128 0.134 0.131 < 300 ¶
Patient Sample 4 0.697 0.689 0.693 345 345
¶ For samples with readout < 300 pg/mL, it is recommended to use the data obtained at 450 nm as shown in
Sample Data at 450 nm in the table above. This practice should give the results with optimum sensitivity of the
assay.
NOTE: The data presented are for illustration purposes only and must not be used in place of data generated
at the time of the assay.
Quality Control
Control serum or serum pools should be analyzed with each run of calibrators and patient samples. Results
generated from the analysis of the control samples should be evaluated for acceptability using appropriate
statistical methods. In assays in which one or more of the quality control sample values lie outside the acceptable
limits, the results for the patient sample may not be valid.
Limitation of the Procedure

 The DRG Calcitonin ELISA kit has exhibited no “high dose hook effect” with samples spiked with
1,000,000 pg/mL of pure intact calcitonin (1-32). The spiked sample gave a result greater than the highest
standard, i.e. 1,000 pg/mL. Samples with calcitonin levels greater than the highest calibrator, however,
should be diluted and reassayed for correct values.
 Like any analyte used as a diagnostic adjunct, calcitonin results must be interpreted carefully with the overall
clinical presentations and other supportive diagnostic tests.

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Expected Values
It is recommended that each laboratory establish its own reference range. The data provided should be used only
as a guideline. Calcitonin levels were measured in fifty-nine (59) apparently normal female individuals and fifty-
two (52) apparently normal male individuals with the DRG Calcitonin ELISA.
The values obtained on the normal females ranged from 0.1 to 10.9 pg/mL and the values obtained on the normal
males ranged from 0.2 to 27.7 pg/mL.
Based on statistical tests on skewness and kurtosis, the population, when transformed logarithmically, follows the
normal or Gaussian distribution as shown in the histograms.
The geometric mean ± 2 standard deviations of the mean for the normal females were calculated to be 0.07 to
12.97 pg/mL and 0.68 to 30.26 pg/mL for the normal males.
Consistent with the literature [2,9], calcitonin levels were found to be generally lower in normal females than in
normal males. Hence, the reference range should be less than 13 and 30 pg/mL, for females and males,
respectively.
Performance Characteristics
Accuracy
Seventy-seven patient samples, with calcitonin values ranging from 0.8 to 3,113 pg/mL were assayed by the DRG
ELISA procedure and an ImmunoRadioMetric Assay Calcitonin (IRMA Kit). Linear regression analysis gives
the following statistics:
DRG ELISA = 0.940 IRMA Kit + 6.55 pg/mL r = 0.993, N = 123
Further, fifty-one patient samples, with calcitonin values ranging from < 0.7 to 2,240 pg/mL were assayed by the
DRG ELISA procedure and Chemiluminescence Immunoassay for Calcitonin Kit [or
ImmunoChemiluminescentMetricAssay (ICMA)]. Linear regression analysis gives the following statistics:
DRG ELISA = 1.094 ICMA Kit - 6.13 pg/mL r = 0.995, N = 123
Sensitivity
The sensitivity, or minimum detection limit, of this assay is defined as the smallest single value, which can be
distinguished from zero at the 95% confidence limit.
The DRG Calcitonin ELISA has a calculated sensitivity of 1.0 pg/mL.
Precision and Reproducibility

The precision (intra-assay variation) of the DRG Calcitonin ELISA Test was calculated from 20 replicate
determinations on each of the three samples.

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Intra-Assay Variation
Mean Value Coefficient of Variation
Sample N
(pg/mL) %
A 24.3 20 5.7
B 94.9 20 4.3
C 403 20 2.8
The total precision (inter-assay variation) of the DRG Calcitonin ELISA Test was calculated from data on three
samples obtained in 15 different assays, by three technicians on two different lots of reagents, over a three-week
period.
Inter-Assay Variation
Mean Value Coefficient of Variation
Sample N
(pg/mL) %
A 16.5 15 7.4
B 64.5 15 7.4
C 340 15 6.1

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Recovery
Various amounts of Calcitonin were added to four different patient sera to determine the recovery. The results are
described in the following table:
Serum Sample Endogenous Calcitonin Expected Measured Recovery
Calcitonin added Value Value
(pg/mL) (pg/mL) (pg/mL) (pg/mL) (%)
A 0 -- -- -- --
0 100 100 110 110%
0 200 200 217 109%
B 9.7 -- -- -- --
8.7 100 109 106 97%
7.8 200 208 207 100%
C 0 --
0 100 100 104 104%
0 200 200 205 103%
D 5.7 --
5.1 126 131 119 91%
4.6 220 225 203 90%
Specificity and Cross-Reactivity

Cross reactant Concentration of Calcitonin without Calcitonin with Change in Cross reactivity
Cross reactant Cross reactant Cross reactant Calcitonin
(pg/mL) (pg/mL) (pg/mL) (%)
100,000 pg/mL 186 194 8 0.00800
PTH 30,000 pg/mL 186 200 14 0.04667
10,000 pg/mL 186 194 8 0.08000
Calcitonin Gene 1,000,000 pg/mL 200 202 2 0.00020
Related Peptide 100,000 pg/mL 200 204 4 0.00400
Salmon 1,000,000 pg/mL 191 194 3 0.00030
Calcitonin 100,000 pg/mL 191 199 8 0.00800
5000 µIU/mL 198 203 5 0.00061
TSH 500 µIU/mL 198 198 0 0.00000
50 µIU/mL 198 199 1 0.01220
Each cross reactant is spiked into a sample containing Calcitonin. Calcitonin level is measured before and after
the spike. None of the cross reactants interfere with this Calcitonin ELISA. The small changes in Calcitonin
measured are well within the intra-assay precision statistics.

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Kinetic Effect of the Assay

To determine whether there is any systematic kinetic effect between the beginning of the run and the end of the
run, three spiked patient serum pools, selected to represent a good cross section of the calcitonin concentration,
were placed in sequence throughout the run of one microplate or 96 wells [with twelve 8-well strips].
Linearity of Patient Sample Dilutions: Parallelism

Six patient serum samples were diluted with Calibrator A (Zero Calibrator). Results in pg/mL are shown below:
Sample Dilution Expected (E) Observed (O) % O/E
A Undiluted - 343 -
1:2 172 168 98%
1:4 85.8 81.3 95%
1:8 42.9 40.3 94%
B Undiluted - 271 -
1:2 136 131 97%
1:4 67.8 70 103%
1:8 33.9 34.3 101%
C Undiluted - 265 -
1:2 133 134 101%
1:4 66 70.4 106%
1:8 33.1 32.5 98%
D Undiluted - >1000 -
1:2 - 1060 -
1:4 530 504 95%
1:8 265 271 102%
E Undiluted - 231 -
1:2 116 116 100%
1:4 57.8 58.8 102%
1:8 28.9 27.1 94%
1:16 14.4 12.1 84%
F Undiluted - >1000 -
1:2 - 997 -
1:4 499 429 86%
1:8 249 223 89%
1:16 125 119 95%

IVD
References
1. Deftos, L.J., Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism, (edited by
Favus, N.J.), 1st Edition, American Society for Bone and Mineral Research, pp 53-55, 1990.
2. Deftos, L.J., Weisman M.H., Williams G.H., Karpf, D.B., Frumar, A.M., Davidson, B.H., Parthemore, J.G.,
Judd, H.L., Influence of age and sex on plasma calcitonin in human beings.
N. Engl. J. Med. 302:1351-1353, 1980.
3. Travis, J.C., (ed) Clinical Radioimmunoassay . . . State-of-the-Art, Scientific News Letters, Inc. Radioassay
- Legend Assay Publishers, Anaheim, CA 92803, 1980, 1st Edition.
4. Austin, L.A., and Heath, H., III, Medical Progress, Calcitonin Physiology and Pathophysiology,
N. Engl. J. Med. 304:269,1981.
5. Pathemore, J.G., Bronzert, G.R., and Deftos, L.J., A short calcium infusion in the diagnosis of medullary
thyroid carcinoma, J. Clin. Endocrinol. Metab. 39:108,1974.
6. Hennedssy, J.F., Wells, S.A., Ontjes, D.A., and Cooper, C.W., A comparison of pentagastrin injection and
calcium infusion as provocative agents for the detection of medullary carcinoma of the thyroid,
J. Clin. Endocrinol. Metab. 39:487, 1974.
7. Wells, S.A., Baylin, S.B., Linehan, W.M. et al, Provocative agents and the diagnosis of medullary carcinoma
of the thyroid gland. Ann. Surg. 188:139, 1978.
8. Body J.J. and Heath III, H. Estimates of circulating monomeric calcitonin: physiological studies in normal
and thyroidectomized man. J. Clin. Endocrinol. Metab. 57:897, 1983
9. Tiegs R.D., Body J.J., Barta J.M., and Heath III, H. Secretion and metabolism of monomeric human
calcitonin: effects of age, sex and thyroid damage. J. Bone Min. Res. 1:339,1986.


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DRG® Calcitonin ELISA (EIA-3648)

Revised 4 Nov. 2010 rm (Vers. 4.1)

Name and Intended Use

Summary and Explanation

DRG International Inc., USA 1

Revised 4 Nov. 2010 rm (Vers. 4.1)

Principle of the Test

Streptavidin Biotinylated Intact HRP conjugated

DRG International Inc., USA 2

Revised 4 Nov. 2010 rm (Vers. 4.1)

Materials required but not supplied

Warnings and Precautions for Users

DRG International Inc., USA 3

Revised 4 Nov. 2010 rm (Vers. 4.1)

Reagent Preparation and Storage

Revised 4 Nov. 2010 rm (Vers. 4.1)

DRG International Inc., USA 5

Revised 4 Nov. 2010 rm (Vers. 4.1)

DRG International Inc., USA 6

Revised 4 Nov. 2010 rm (Vers. 4.1)

Limitation of the Procedure

DRG International Inc., USA 7

Revised 4 Nov. 2010 rm (Vers. 4.1)

Precision and Reproducibility

DRG International Inc., USA 8

Revised 4 Nov. 2010 rm (Vers. 4.1)

DRG International Inc., USA 9

Revised 4 Nov. 2010 rm (Vers. 4.1)

Specificity and Cross-Reactivity

DRG International Inc., USA 10

Revised 4 Nov. 2010 rm (Vers. 4.1)

Kinetic Effect of the Assay

Linearity of Patient Sample Dilutions: Parallelism

DRG International Inc., USA 11

Revised 4 Nov. 2010 rm (Vers. 4.1)

DRG International Inc., USA 12

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