Product catalogue 2015-2016 - Diametra 2015 2016 LR.pdfProduct catalogue 2015-2016 ... DKO106 Anti...

Diametra srl is part of IDS Group

Product catalogue 2015-2016

Head Office Manufacturing

20090 Segrate (MI) Italy 06038 Spello (PG) ItalyVia Calabria 15 Via Pozzuolo 14

Ph: +39 02 2139184 Ph: +39 0742 301929 Ph: +39 02 26921595 Ph: +39 0742 24851Fax: +39 02 2133354 Fax: +39 0742 316197

www.diametra.com - [email protected]

catalogo 2015 2016 MOD_rev1.qxp__Layout 1 28/09/15 11:31 Pagina 1

Diametra srl is part of IDS Group

Product catalogue 2015-2016

reliability and competence

Head Office Manufacturing

20090 Segrate (MI) Italy 06038 Spello (PG) ItalyVia Calabria 15 Via Pozzuolo 14

Ph: +39 02 2139184 Ph: +39 0742 301929 Ph: +39 02 26921595 Ph: +39 0742 24851Fax: +39 02 2133354 Fax: +39 0742 316197


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The new R&D and Manufacturing Plant in Spello • Perugia • Italy

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Setting a Gold Standard in Endocrinology

Free Testosterone

* Monoclonal Antibody for better reproducibility and specificity

*Less interferences of matrix effect in samples

*Easy to automate

*Unsurpassed sensitivity

Diametra is part of IDS group


5

Index

AutoImmune Diseases 6

Diabetes 7

Tumor Markers 12

Saliva - Steroid Hormones 14

Saliva tests & devices 14

Steroid Hormones Serum 15

Controls and Calibrators 16

Fertility Proteic Hormones 16

Thyroid Monitoring 18

Hypertension 20

Calcium Metabolism 20

Miscellaneous 20


6

AUTOIMMUNE DISEASESImmunoenzymatic assay (ELISA) for the quantitative determination of autoantibodies.

Method on microplate (96 breakable wells), TMB.

GASTROENTEROLOGY

Code Item Sensitivity Specificity

DKO106 Anti Deamidated Gliadin Peptides (DGP) IgG 94,1 % >99,0 %DKO107 Anti Deamidated Gliadin Peptides (DGP) IgA >99,0 % 97,6 %DKO140 Anti Transglutaminase IgA 1,0 AU/mL * >99,0 %DKO141 Anti Transglutaminase IgG 1,0 AU/mL * >99,0 %

* Sensitivity expressed as a minimum detection limit

THROMBOSIS


DKO110 Anti Beta2 Glycoprotein 1 IgG 76,5 % 95,8 %DKO111 Anti Beta2 Glycoprotein 1 IgM 82,3 % 95,8 %DKO112 Anti Cardiolipin IgM 81,8 % >99,0 %DKO113 Anti Cardiolipin IgG 75,0 % 70,0 %DKO114 Anti Phospholipid Screen IgG 92,3 % 84,6 %

IgM 68,8 % >99,0 % DKO144 Anti Cardiolipin screen IgG 75,0 % 70,0 %

IgM 81,8 % >99,0 %DKO145 Anti Beta2 Glycoprotein 1 Screen IgG 76,5 % 95,8 %

IgM 82,3 % 95,8 %

ANCA VASCULITIS


DKO091 Anti PR-3 (c-ANCA) >99,0 % >99,0 %DKO092 Anti MPO (p-ANCA) >99,0 % >99,0 %

GASTROENTEROLOGY


DKO106 Anti Deamidated Gliadin Peptides (DGP) IgG 94,1 % >99,0 %DKO107 Anti Deamidated Gliadin Peptides (DGP) IgA >99,0 % 97,6 %DKO140 Anti Transglutaminase IgA 1,0 AU/mL * >99,0 %DKO141 Anti Transglutaminase IgG 1,0 AU/mL * >99,0 %

* Sensitivitytyt exexe pxpx ressed as a minimum detection limit


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THYROID


DKO085 TSH Receptor Ab 98,0 % >99,0 %DKO115 Anti TG 96,3 % 94,9 %DKO116 Anti TPO 94,0 % 92,9 %

DIABETES


DKO082 Anti-GAD 88,6 % 92,3 %DKO083 IAA 77,0 % 94,0 %DKO084 Anti-IA2 65,3 % 100,0 % ZnT8Ab ZnT8Ab only for italian market 68,0 % 99,0 %

RHEUMATOLOGY


DKO095 Anti dsDNA IgG >99,0 % >99,0 %DKO098 ENA SCREEN 94,7 % 92,3 %DKO099 ANA SCREEN 87,1 % 80,0 %DKO117 Anti CCP 79,0 % 97,0 %DKO119 ENA profile 97,7 % 97,0 %DKO149 Anti CP IgG 76,0 % 94,0 %


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and rerer searcrcr h inini stitutetet s.

• Anti CP IgG


DIBETES MONITORING

Immunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.Direct method on microplate (96 breakable wells), TMB.

Code Item Sensitivity Analytical Range

DKO076 Insulin 0,25 μIU/mL 3,0 – 200 μIU/mLDKO077 C-Peptide 0,01 ng/mL 0,2 – 10 ng/mL DKO128 Fetuin A 0,04 ng/mL 6,5 – 208 ng/mL


DKO082 Anti-GAD 88,6 % 92,3 %DKO083 IAA 77,0 % 94,0 %DKO084 Anti-IA2 65,3 % 99,0 % ZnT8Ab ZnT8Ab only for italian market 68,0 % 99,0 %

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Tumor markers

Wide range of Analytes including common and esoteric tests

Diametra is part of IDS Group


12

TUMOR MARKERSImmunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.

Direct method on microplate (96 breakable wells), TMB


DKO012 AFP 0,35 ng/mL 5,0 – 200 ng/mLDKO051 CEA 0,11 ng/mL 5,0 – 250 ng/mLDKO054 CA 125 1,7 U/mL 15 – 400 U/mLDKO055 CA 15-3 0,5 U/mL 15 – 240 U/mLDKO056 CA 19-9 0,18 U/mL 15 – 240 U/mLDKO057* PSA 0,5 ng/mL 5,0 – 100 ng/mLDKO064* Free PSA 0,052 ng/mL 0,5 – 10 ng/mLDKO073 hNSE 0,19 ng/mL 4,0 – 100 ng/mL DKO074 S100 B 35 pg/mL 10 – 5000 pg/mLDKO137 Total PSA 0,2 ng/mL 1,56 – 25 ng/mLDKO138 Free PSA 0,1 ng/mL 0,75 – 12 ng/mLDKO183* Free B-HCG 0,019 mIU/mL 5,0 – 250 mIU/mLDKO184* PAPP-A 34 mIU/L 100– 10.000 mIU/LTM E 9000 CHROMOGRANIN A only for italian market 12,4 µg/L 50 - 1.500 µg/L

* RUO: For research use only


STEROID HORMONES

Among the most complete panel available on the market

Since 1997, the Diametra steroid hormone menu representsthe status of the art

• Well proven quality•Reagents ready to use • Shelf life over 15 months• Each product is CE marked.

• Same procedure for the whole panel and same common rea-gents:easy applicaon on the most popular microplate auto-analyzers.

Diametra is part of IDS group

IMMUNOASSAY UNIT


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SALIVARY BIOMARKERS

Immunoenzymatic assay (ELISA) for the quantitative determination in saliva.Competitive method on microplate (96 breakable wells), TMB

Steroid Hormones in Saliva


DKO020 Cortisol Saliva 0,12 ng/mL 0,5 – 100 ng/mLDKO021 Testosterone Saliva 3,0 pg/mL 10 – 1000 pg/mLDKO022 Estradiol Saliva 0,5 pg/mL 1,0 – 100 pg/mLDKO024 DHEA-S Saliva 0,05 ng/mL 0,2 – 12 ng/mLDKO025 Progesterone Saliva 3,8 pg/mL 10 – 5000 pg/mLDKO026 Estriol Saliva < 2,0 pg/mL 2,5 – 4000 pg/mLDKO027 Androstenedione Saliva 5,0 pg/mL 20 – 1000 pg/mLDKO178 Estriol Saliva HS 1,48 pg/mL 2,0 -315 pg/mL

Saliva Miscellaneous


DKO078 Salivary IgA 0,5 µg/mL 6,9 – 400 µg/mLDKO063 Saliva Collector Devices 100 testsDKO120 Salivette™ ( Sarsted ) 100 testsDKO067 Saliva Control 1 x 3 x 2 mL



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STEROID HORMONES IN SERUM

Immunoenzymatic assay (ELISA) for the quantitative determination in serum or plasma.Competitive method on microplate (96 breakable wells), TMB


DKO001 Cortisol 2,44 ng/mL 10 – 500 ng/mLDKO002 Testosterone 0,10 ng/mL 0,2 – 16 ng/mLDKO003 Estradiol 8,7 pg/mL 20 – 2000 pg/mLDKO004 17 OH-Progesterone 0,05 ng/mL 0,2 – 20 ng/mLDKO005 DHEA-S 0,03 µg/mL 0,1 – 10 µg/mLDKO006 Progesterone 0,05 ng/mL 0,2 – 40 ng/mLDKO007 Free Estriol 0,03 ng/mL 0,15 – 40 ng/mLDKO008 Androstenedione 0,01 ng/mL 0,1 – 10 ng/mL DKO015 Free Testosterone 0,04 pg/mL 0,2 – 100 pg/mLDKO019 Total Estriol 0,22 ng/mL 2,0 – 200 ng/mL DKO053 Aldosterone 7,0 pg/mL 20 – 2000 pg/mLDKO124 DHEA 0,1 ng/mL 0,5 – 30 ng/mL

STEROID HORMONE IN URINE


DKO018 Urinary Cortisol 2,9 ng/mL 10 – 500 ng/mL


16

CONTROLS AND CALIBRATORS

Code Item

DKO067 Saliva Controls 1 x 3 x 2 mLDKO156 Diametra Hormone Control plus 1 x 3 x 3 mL

FERTILITY PROTEIC HORMONES

Immunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.Direct method on microplate (96 breakable wells), TMB


DKO009 LH 0,22 IU/mL 5,0 – 200 IU/mLDKO010 FSH 0,17 IU/mL 5,0 – 100 IU/mLDKO011 PROLACTIN 0,12 ng/mL 5,0 – 100 ng/mLDKO014 b-HCG 0,09 mIU/mL 1,0 – 400 mIU/mLDKO087 SHBG 0,2 nmol/mL 2,78 – 278 nmol/mL


The most up to date THYROID PROFILE

TSH FT4 FT3 T4 T3Thyreoglobulin - Anti TSH Receptors

Anti Tg - Anti TPO

Complete functional andimmunological status assessment

Diametra is part of IDS Group


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THYROID MONITORING

Immunoenzymatic determination (ELISA) in serum or plasma.Direct sandwich or competitive method on microplate (96 breakable wells) T.M.B.


DKO013 TSH 0,01 mIU/L 0,2 – 20 mIU/LDKO037 FT3 0,05 pg/mL 0,4 – 18 pg/mLDKO038 FT4 0,05 ng/dL 0,3 – 7,0 ng/dLDKO044 T3 5,0 ng/dL 50 – 750 ng/dLDKO045 T4 0,4 μg/dL 2,0 – 25 μg/dLDKO048 Thyreoglobulin 0,44 ng/mL 2,0 – 250 ng/mL


DKO115 Anti TG 96,3 % 94,9 %DKO116 Anti TPO 94,0 % 92,9 %DKO085 TSH Receptor Ab 98,0 % >99,0 %


INFECTIOUS DISEASES

Immunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.Direct method on microplate (96 breakable wells), TMB

Code Item Test principle/range Incubation time

DKI001 Epstein Barr Virus VCA IgA Quantitative 0,1 – 150 U/mL 60 + 30 + 20 minDKI002 Epstein Barr Virus VCA IgG Qualitative/semiquantitative 60 + 60 + 20 minDKI003 Epstein Barr Virus VCA IgM Qualitative/semiquantitative 60 + 60 + 20 minDKI004 Herpes simplex Virus Type 1 IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI005 Herpes simplex Virus Type 1 IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI006 Herpes simplex Virus Type 2 IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI007 Herpes simplex Virus Type 2 IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI008 Herpes simplex Virus Type 1+2 IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI009 Herpes simplex Virus Type 1+2 IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI010 Chagas (Trypanosoma cruzi) IgG Qualitative 30 + 30 + 30 minDKI011 Dengue Virus IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI012 Dengue Virus IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI013 Malaria Ab (IgG, IgM, IgA) Qualitative/semiquantitative 30 + 30 + 30 minDKI014* Chlamidia trachomatis IgA Qualitative 60 + 30 + 15 minDKI015* Chlamidia trachomatis IgG Qualitative 60 + 30 + 15 minDKI016* Chlamidia trachomatis IgM Qualitative 60 + 30 + 15 minDKI017 Helicobacter pylori IgG Qualitative/quantitative 0 – 150 DU/mL 60 + 30 + 15 minDKI018 Helicobacter pylori IgM Qualitative 30 + 30 + 20 minDKI019 Helicobacter pylori IgA Qualitative/quantitative 0 – 150 DU/mL 60 + 30 + 15 minDKI020 Helicobacter pylori Ag in stools Qualitative/quantitative 0 – 1 μg/mL 120 + 20 minDKI021 Helicobacter pylori Ag in stools extraction kitDKI022 HAV Antigen in stools Qualitative/semiquantitative 120 + 120 + 30 minDKI023 Treponema pallidum IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI024 Treponema pallidum IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI025 Treponema pallidum Screen Qualitative 60 + 30 + 15 minDKI026 Tetanus toxin (Antitoxin) IgG Quantitative 0,2 – 1 IU/mL 60 + 30 + 15 min


HYPERTENSION

Immunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.Method on microplate (96 breakable wells), TMB


DKO053 Aldosterone 7,0 pg/mL 20 – 2000 pg/mLDKO150 Renin 0,8 pg/mL 3,9 - 270 pg/mL

CALCIUM METABOLISM



DKO146 25 OH Vitamin D 0,67 ng/mL 2,5 – 150 ng/mL

CIRCULATING IMMUNOCOMPLEX

Immunoenzymatic determination of specific circulating immunocomplexes in plasma or serum

Code Item Sensitivity Analytical RangeDKO016 CIC C1q 1,0 μg Equiv/mL 16 – 64 μg Equiv/mLDKO017 CIC C3d 1,0 μg Equiv/mL 16 – 64 μg Equiv/mLDKO040 CH50 0 – 100%

MISCELLANEOUS



DKO039 Ferritin 0,53 ng/mL 5,0 – 1000 ng/mLDKO050 HGH 0,1 μIU/mL 2,0 – 150 μIU/mLDKO060 IgE Total 0,27 IU/mL 5,0 – 400 IU/mLDKO180 Troponin 1 0,03 ng/mL 1,0 – 30 ng/mLDKO186 IGF 1 7,8 ng/mL 14 - 800 ng/mLDKO181 Calcitonin 0,7 pg/mL 10 – 400 pg/mL

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25 OH-Vitamin DELISA IMMUNOASSAY

No sample treatmentNo organic solvents

Easy automationSensitive and Accurate

100% cross reactivity to D2 and D3

DIAMETRA IS PART OF IDS GROUP


SALES CONDITIONS

Prices and TermsPrices are in Euro, EX WORKS SPELLO - PERUGIA - ITALY unless differently agreed.Prices will be effective at the date of the order acknowledgment by DiaMetra.Goods will be delivered as per your instructions.Handling fees will be billed in the invoice.

Minimum Acceptable Order: Euro 250,00

Payment termsUnless otherwise agreed in writing, payment shall be made by cash in advance.Should the payment be made in whole or in part after delivery, the delivered products remain property of DiaMetrasrl until the payment obligations have been entirely fulfilled.

Claim and ReturnDiaMetra srl is committed to fulfill and ship out the orders promptly. If wrong deliveries or damage to the products do occur, please notify them to us immediately. If the purchaser fails to notify DiaMetra of such defects within 10 days, the products will be deemed in compliancewith the specifications.DiaMetra srl sole obligation is limited to the replacement of the products proven as defective.In no case DiaMetra shall be liable for indirect, incidental or consequential damages to the use of the products.Return of goods will not be accepted without prior written authorization by DiaMetra.

For any controversy or dispute arising out or related to the interpretation of the present general conditions and/orany contract connected there with, the competent court of MILANO, Italy will have exclusive jurisdiction.

contact us

Headquarter R & D and Manufacturing 20090 Segrate - Milano Italy 06038 SPELLO - Perugia Italy Via Calabria, 15 Via Pozzuolo, 14 phone +39.02.21.39.184 phone +39.0742.30.19.29 phone +39.02.26.92.15.95 phone +39.0742.24.851 fax +39.02.21.33.354 fax +39.0742.31.61.97

E mail: Customer service [email protected]

[email protected] Product Manager [email protected] Managing Director [email protected] Chief Operating Officier [email protected]

www.diametra.com


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