Clinical Diagnostics - PDF document

1 Clinical Diagnostics CATALOGUE 2014 1 Fe
Clinical Diagnostics CATALOGUE 2014 1 Few words about XEMA XEMA Co. Ltd. is a private company established 02/93 in Moscow. We started our operations as the contract manufacturers of human antigens; now our company is among world leaders in production of tumor marker antigens and correspondent monoclonal antibodies. Our broad hybridoma collection enables us to manufacture large quantities of puried monoclonal antibodies for in vitro diagnostic use. We are proud to maintain a high level of research work focused on several main research topics:  biochemistry and immunology of human tumor markers (CEA, CA125, 4, CA19-9, CA72-4, MUC1, cytokeratines etc);  development of immunoassays for hormones, inammation and tumor markers for pet and laboratory animals;  immunochemistry of food antigens and food contaminants;  development of immunoassays for evaluation of fungal contamination of foods and environ¬ment; Since 1997, we have entered a very tough market of nished in vitro diagnostic reagents with the broad panel of EIA kits, including determination of hormones, tumor markers, prenatal and neona - tal markers, thyroid autoimmunity markers and infection serology. Besides, our company developed a number of kits for research use in medicine, eg Alveomu - cin EIA (diagnostics and monitoring of interstitial lung diseases), Tissue Transglutaminase EIA (investiga¬tion of tTG expression in celiac disease), etc. Our product line is consistently growing – in 2013, we have launched 9 new tests. Since 2003, our IVD kit development, production and sale is certied to ISO 9001, since 2009 – to ISO 13485. In 2003, we have set up a joint venture with our colleagues from Minsk, Belorussia to manufacture and sell our kits in this country. In October, 2004 we opened our subsidiary in St- Pe - tersburg, Russia. In 2008 we also started our

2 operations in Ukraine (XEMA Co. Ltd.),
operations in Ukraine (XEMA Co. Ltd.), in 2011 estab - lished two sister companies – XEMA Biotech Beijing Co Ltd in China and XEMA OY in Finland, and in 2013 registered our company in Malaysia – XEMA Malaysia Sdn Bhd. Since 1999, XEMA oers IVD kits and their components for Russian and international markets. We export our production to C.I.S. countries, Germany, Italy, Belgium, Finland, China, Israel, Turkey, India, Iran, Malaysia, Indonesia. Our annual sales in 2012 reached ca 7M USD. Dr. Yuri S. Lebedin, General Manager, XEMA Group of companies 2 TABLE OF CONTENTS TUMOR MARKERS THYROID GLAND: HORMONES AND DISEASE MARKERS Diagnostic algorythm for thyroid pathology REPRODUCTION AND PREGNANCY Prenatal screening Neonatal screening HORMONES IN SALIVA OTHER HORMONES DIAGNOSTICS OF AUTOIMMUNE DISEASES DIAGNOSTICS OF INTERSTITIAL LUNG DISEASES (alveolitis) DIAGNOSTIC MARKERS OF HEART AND VESSEL DISEASES DIAGNOSTICS OF ALLERGY AND FOOD INTOLERANCE INFECTIOUS SEROLOGY HUMORAL IMMUNITY AND ACUTE PHASE PROTEINS QUALITY CONTROL SERA FOR IMMUNOASSAYS REAGENTS FOR IMMUNOCHEMISTRY, IMMUNOHISTOCHEMISTRY AND FLOW CYTOMETRY Kit format: 96-well microplate, breakable strips, all reagents are liquid and ready-to-use, dispensed in plastic vials with screw caps, chromogen – single component TMB, shelf life– 12months. Our legal address: apt. 2, bldg. 3, 3, The 4th Vosmogo Marta st., 125319, Moscow, RUSSIA Our oce: 48, 9th Parkovaya str., 105264 Moscow, RUSSIA Tel./Fax: +7 495 737 39 36, +7 495 737 00 40 redkin@xema-medica.com www.xema-medica.com 3 TUMOR MARKERS Human Chorionic Gonadotropin (HCG) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 2.5 IU/l Incubation: Calibrators: 60’/15’, 37 6 (0–500 IU/l) Control sample: Shelf life: 1 12 months Total Prostate Specic Antigen (tPSA) EIA Sample type: Sample

3 volume: Sensitivity: serum, plasma 50 &#
volume: Sensitivity: serum, plasma 50 l 0.1 ng/ml Incubation: Calibrators: 60’/15’, 37 5 (0–30 ng/ml) Control sample: Shelf life: 1 12 months XEMAtest tPSA, 50 tests/pack New test! Sample type: Sample volume: Sensitivity: serum, plasma 30–40 l 4,0 ng/ml Incubation: Calibrators: 10’, +18...+25 °C no Control sample: Shelf life: no 24 months Free Prostate Specic Antigen (fPSA) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.07 ng/ml Incubation: Calibrators: 30’/30’/15’, 37 5 (0–5 ng/ml) Control sample: Shelf life: 1 12 months CA125 EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.5 U/ml Incubation: Calibrators: 60’/15’, 37 6 (0–400 U/ml) Control sample: Shelf life: 1 12 months XEMAtest  125, 10 tests/pack New test! Sample type: Sample volume: Sensitivity: serum, plasma 30-40 l 35 U/ml Incubation: Calibrators: 10’, +18...+25 °C no Control sample: Shelf life: no 24 months K239HE-4 EIA New test! Sample type: Sample volume: Sensitivity: serum, plasma 20 l 10 pmol/l Incubation: Calibrators: 60’/15’, 37 °C 6 (0–1000 pmol/l) Control sample: Shelf life: 2 12 months XEMAtest 4, 5 tests/pack New test! Sample type: Sample volume: Sensitivity: serum, plasma 30-40 l 150 pmol/l Incubation: Calibrators: 10’, +18...+25 °C no Control sample: Shelf life: no 24 months X22OVXEMAtest OvaScreen, 5 tests/pack New test! Sample type: Sample volume: Sensitivity: CA125 HE4 serum, plasma 30-40 l 35 U/ml 150 pmol/l Incubation: Calibrators: 10’, +18...+25 °C no Control sample: Shelf life: no 24 months 4 CA19-9 EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 2.0 U/ml Incubation: Calibrators: 30’/30’/15’, 37 5 (0–2

4 40 U/ml) Control sample: Shelf life: 1 1
40 U/ml) Control sample: Shelf life: 1 12 months Carcinoembryonic antigen (CEA) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 1.0 ng/ml Incubation: Calibrators: 60’/15’, 37 6 (0–64 ng/ml) Control sample: Shelf life: 1 12 months Alpha-Fetoprotein (AFP) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 2.0 U/ml Incubation: Calibrators: 60’/15’, 37 6 (0–500 U/ml) Control sample: Shelf life: 1 12 months Thyroglobulin (TG) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 1.0 ng/ml Incubation: Calibrators: 60’/15’, 37 5 (0–400 ng/ml) Control sample: Shelf life: 1 12 months New test! Sample type: Sample volume: Sensitivity: serum, plasma 25 l 0.6 g/l Incubation: Calibrators: 30’/30’/15’, 37 5 (0–150 g/l) Control sample: Shelf life: 1 12 months YFRA-21-1 EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 1.0 ng/ml Incubation: Calibrators: 60’/15’, 37 5 (0–50 /) Control sample: Shelf life: 1 12 months  72-4 EIA Sample type: Sample volume: Sensitivity: serum, plasma 10 l 2.0 U/ml Incubation: Calibrators: 120’/60’/15’, 37 °C 5 (0–200 U/ml) Control sample: Shelf life: 1 12 months Mammary carcinoma monitoring (MUC1 determination) M12 (CA 15.3) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 1.5 U/ml Incubation: Calibrators: 30’/30’/15’, RT, shaker 5 (0–250 U/ml) Control sample: Shelf life: 1 12 months M22 (analogous to MC, Roche) Sample type: Sample volume: Sensitivity: serum, plasma 50 l 1.5 U/ml Incubation: Calibrators: 30’/30’/15’, RT, shaker 6 (0–100 U/ml) Control sample: Shelf life: 1 12 months M20 (analogous to BR 27.29, Biomira) Sample type:

5 Sample volume: Sensitivity: serum, plas
Sample volume: Sensitivity: serum, plasma 50 l 1.0 U/ml Incubation: Calibrators: 60’/15’, 37 6 (0–50 U/ml) Control sample: Shelf life: 1 12 months 5 THYROID GLAND: HORMONES AND DISEASE MARKERS Diagnostic algorithm for thyroid pathology 6 Thyroid Stimulating Hormone (TSH) EIA, normal range Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.08 mIU/l Incubation: Calibrators: 60’/15’, 37 6 (0–20 mIU/l) Control sample: Shelf life: 1 12 months Thyroid Stimulating Hormone EIA, expanded range (TSH-plus EIA) Sample type: Sample volume: Sensitivity: serum, plasma 100 l 0.025 mIU/l Incubation: Calibrators: 60’/60’/15’, 37 7 (0–50 mIU/l) Control sample: Shelf life: 2 12 months 201N TSH-Neo EIA Sample type: Sensitivity: Dried blood spots 3.0 µIU /ml Incubation: 12–18 hr/60’/15’, RT, shaker Calibrators: Shelf life: 6 (0–250 µIU/ml) 12 months Total 3 EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.4 nmol/l Incubation: Calibrators: 30’/15’, 37 5 (0–15 nmol/l) Control sample: Shelf life: 1 12 months Total T4 EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 6 nmol/l Incubation: Calibrators: 60’/15’, 37 5 (0–320 nmol/l) Control sample: Shelf life: 1 12 months K2 Free T3 EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 1 pmol/l Incubation: Calibrators: 60’/15’, 37 6 (0–40 pmol/l) Control sample: Shelf life: 1 12 months K Free T4 EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 1.5 pmol/l Incubation: Calibrators: 60’/15’, 37 6 (0–100 pmol/l) Control sample: Shelf life: 1 12 months Thyroperoxidase autoantobodies (anti-TPO) EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitiv

6 ity: Incubation: Calibrators: 5 IU/ml 3
ity: Incubation: Calibrators: 5 IU/ml 30’/30’/15’, RT 5 (0–1000 IU/ml) Control sample: Shelf life: 1 12 months Thyroglobulin autoantobodies (anti-TG) EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitivity: Incubation: Calibrators: 10 IU/ml 30’/30’/15’, RT 5 (0–3000 IU/ml) Control sample: Shelf life: 1 12 months Thyroglobulin (TG) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 1.0 ng/ml Incubation: Calibrators: 60’/15’, 37 5 (0–400 ng/ml) Control sample: Shelf life: 1 12 months 7 REPRODUCTION AND PREGNANCY Luteinizing hormone (LH) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.3 IU/l Incubation: Calibrators: 60’/15’, 37 5 (0–100 IU/l) Control sample: Shelf life: 1 24 months Follicle Stimulating Hormone (FSH) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.3 IU/l Incubation: Calibrators: 60’/15’, 37 5 (0–100 IU/l) Control sample: Shelf life: 1 24 months Human Chorionic Gonadotropin (HCG) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 2.5 IU/l Incubation: Calibrators: 60’/15’, 37 6 (0–500 IU/l) Control sample: Shelf life: 1 12 months Prolactin EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 10 mIU/l Incubation: Calibrators: 60’/15’, 37 5 (0–2000 mIU/l) Control sample: Shelf life: 1 12 months Progesterone EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 0.5 nmol/l Incubation: Calibrators: 120’/15’, 37°C 7 (0–300 nmol/l) Control sample: Shelf life: 1 12 months Estradiol EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 0.05 nmol/l Incubation: Calibrators: 120’/15’, 37 6 (0–20 nmol/l) Control sample: Shelf life: 1 12 months Testoste

7 rone EIA Sample type: Sample volume: Sen
rone EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 0.3 nmol/l Incubation: Calibrators: 120’/15’, 37 6 (0–100 nmol/l) Control sample: Shelf life: 2 12 months DHEA-S EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 0.05 g/ml Incubation: Calibrators: 60’/15’, 37 6 (0–10 g/ml) Control sample: Shelf life: 1 12 months 17--Progesterone EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.25 nmol/l Incubation: Calibrators: 90’/15’, 37 6 (0–100 nmol/l) Control sample: Shelf life: 1 12 months 8 Prenatal screening Human Chorionic Gonadotropin (HCG) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 2.5 IU/l Incubation: Calibrators: 60’/15’, 37 6 (0–500 IU/l) Control sample: Shelf life: 1 12 months Alpha-Fetoprotein (AFP) EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 2.0 U/ml Incubation: Calibrators: 60’/15’, 37 6 (0–500 U/ml) Control sample: Shelf life: 1 12 months Free Estriol EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 0.25 nmol/l Incubation: Calibrators: 120’/15’, 37 °C 6 (0–50 nmol/l) Control sample: Shelf life: 1 12 months Free beta-HCG EIA Sample type: Sample volume: Sensitivity: serum, plasma 20 l 2.0 ng/ml Incubation: Calibrators: 30’/30’/15’, 37 5 (0–250 ng/ml) Control sample: Shelf life: 1 12 months PAPP-A EIA Sample type: Sample volume: Sensitivity: serum, plasma 10 l 20 mU/l Incubation: Calibrators: 60’/15’, 37 6 (0–10 000 mU/l) Control sample: Shelf life: 1 12 months Software for Calculation of Risk of Down Syndrome (CaRDS) during st and 2 nd trimester of pregnancy. Neonatal screening 201N TSH-Neo EIA Sample type: Sensitivity: Dried blood spots 3.0 µIU /ml

8 Incubation: 12–18 hr/60’/15
Incubation: 12–18 hr/60’/15’, RT, shaker Calibrators: Shelf life: 6 (0–250 µIU/ml) 12 months IRT-Neo EIA New test! Sample type: Sensitivity: Dried blood spots 2 ng/ml Incubation: Calibrators: 16-24 hr/15’/15’, 18-25 °C 6 (0-300 ng/ml) Shelf life: 12 months 9 HORMONES IN SALIVA Salivary Progesterone EIA Sample type: Sample volume: Sensitivity: saliva 100 l 0,02 nmol/l Incubation: Calibrators: 60’/15’, 37 ° 6 (0–5 nmol/l) Control sample: Shelf life: 1 12 months Salivary Testosterone EIA Sample type: Sample volume: Sensitivity: saliva 100 l 0,015 nmol/l Incubation: Calibrators: 20’/120’/15’, 37 7 (0–10 nmol/l) Control sample: Shelf life: 2 12 months Salivary Cortisol EIA Sample type: Sample volume: Sensitivity: saliva 50 l 0.3 ng/ml Incubation: Calibrators: 60’/15’, 37 6 (0–45 ng/ml) Control sample: Shelf life: 2 12 months OTHER HORMONES Human Growth (Somatotropic) Hormone EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.25 mIU/l Incubation: Calibrators: 60’/15’, 37 5 (0–50 mIU/l) Control sample: Shelf life: 1 12 months Cortisol EIA Sample type: Sample volume: Sensitivity: serum, plasma 25 l 12 nmol/l Incubation: Calibrators: 60’/15’, 37 6 (0–2000 nmol/l) Control sample: Shelf life: 1 12 months DIAGNOSTICS OF AUT OIMMUNE DISEASES Thyroperoxidase autoantobodies (anti-TPO) EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitivity: Incubation: Calibrators: 5 IU/ml 30’/30’/15’, RT 5 (0–1000 IU/ml) Control sample: Shelf life: 1 12 months Thyroglobulin autoantobodies (anti-TG) EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitivity: Incubation: Calibrators: 10 IU/ml 30’/30’/15’, RT 5 (0–

9 3000 IU/ml) Control sample: Shelf life:
3000 IU/ml) Control sample: Shelf life: 1 12 months Myeloperoxidase autoantibodies (anti-MPO, p-ANCA) EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitivity: Incubation: Calibrators: 3 U/ml 30’/30’/15’, RT 6 (0–100 U/ml) Control sample: Shelf life: 1 12 months 10 D IAGNOSTICS OF INTERSTITIAL LUNG DISEASES (alveolitis) Alv eomucin Sample type: Sample volume: Sensitivity: serum, plasma 50 l 20 U/ml Incubation: Calibrators: 30’/30’/15’, RT, shaking 5 (0–200 U/ml) Control sample: Shelf life: 1 12 months DIAGNOSTIC MARKERS OF HEART AND VESSEL DISEASES K Troponin I (TnI) Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.25 ng/ml Incubation: Calibrators: 60/15’, 37 5 (0–10 ng/ml) Control sample: Shelf life: 1 12 months K CRP ultra EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 25 l Sensitivity: Incubation: Calibrators: 0.05 mg/l 30’/30’/15’, 37 6 (0–25 mg/l) Control sample: Shelf life: Normal range, mg/l: 1 12 months 0–5.0 D IAGNOSTICS OF ALLERGY AND FOOD INTOLERANCE K Total IgE EIA Sample type: Sample volume: Sensitivity: serum, plasma 50 l 6 IU/ml Incubation: Calibrators: 30’/30’/15’, 37 5 (0–1000 IU/ml) Control sample: Shelf life: Normal range, IU/ml: 1 12 months Specic IgE EIA A solid-phase enzyme immunoassay for the quantitative determination of allergen-specic IgE in blood serum or plasma. Sample type: Sample volume: Sensitivity: serum, plasma 50 l 0.1 IU/ml Incubation: Calibrators: 60’/60’/30’/15’, RT, shaking 5 (0–17.5 IU/ml) Control sample: Shelf life: 1 12 months Gliadin IgG EIA K Gliadin IgA EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitivity: Incubation: Calibrators: 5 U/ml 3

10 0’/30’/15’, RT 5 (0–
0’/30’/15’, RT 5 (0–200 U/ml) Control sample: Shelf life: Normal range, U/ml: 1 24 months Deamidated Gliadin IgG EIA Deamidated Gliadin IgA EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitivity: Incubation: Calibrators: 5 U/ml 30’/30’/15’, 37 6 (0–100 U/ml) Control sample: Shelf life: 1 12 months 11 Anti-tTG IgG EIA Anti-tTG IgA EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Sensitivity: Incubation: Calibrators: 2 U/ml 30’/30’/15’, 37 6 (0–200 U/ml) Control sample: Shelf life: Normal range, U/ml: 1 12 months (), () Tissue Transglutaminase EIA Celiac disease (CD) or gluten-sensitive entheropathy is a chronic disease characterized by impaired intestinal absorption due to mucosal lesions. The exact ethiology of CD is unknown but it is clearly shown that gliadin– the alcohol soluble fraction of wheat gluten – is the toxic agent. Gliadin serves as a substrate for tissue Transglutaminase (tTG) – a calcium-dependent enzyme which is a constituent of the intestine mucosa. Gliadin-tTG complex antigen induces formation of IgA- and – later on – IgG- autoantibodies in patients with acute CD. Investigation of tTG expression may be helpful in celiac disease research. Sample type: Sample volume: Sensitivity: serum, plasma 100 l 2 µg/ml Incubation: Calibrators: 30’/30’/30’/15’, 37 4 (0–500 µg/ml) Control sample: Shelf life: 1 12 months INFECTIOUS SEROLOGY Anti-HIV I(0), II/p24 EIA New test! Sample type: Sample volume: serum, plasma 70 l Incubation: 30’, 37 ° /10’, RT, shaking/10’ 37 ° Control samples: Shelf life: 3 12 months HBsAg EIA Coming soon! Anti-HCV EIA, 3 rd generation Coming soon! K101 Toxoplasma IgG EIA Sample type: Sample predi

11 lution: Sample volume: serum, plasma 1:
lution: Sample volume: serum, plasma 1:101 100 l Incubation: Calibrators: Control sample: 30’/30’/15’, 37 °C 5 (0–200 IU/ml) 1 Shelf life: 12 months Toxoplasma IgM EIA Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 60’/30’/15’, 37 2 Shelf life: 12 months Rubella IgG EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Incubation: Calibrators: Control sample: 30’/30’/15’, 37 °C 5 (0–200 IU/ml) 1 Shelf life: 12 months Rubella IgM EIA Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 60’/30’/15’, 37 2 Shelf life: 12 months CMV IgG EIA (semi-quantitative) Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Incubation: Control samples: 30’/30’/15’, 37 °C 3 Shelf life: Normal range (K value): 12 months 5 103 CMV IgM EIA Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 60’/30’/15’, 37 2 Shelf life: 12 months 12 K104 HSV ½ IgG EIA (semi-quantitative) Sample type: Sample predilution: Sample volume: serum, plasma 1:101 100 l Incubation: Control samples: 30’/30’/15’, 37 °C 3 Shelf life: Normal range (K value): 12 months 5 104 HSV ½ IgM EIA Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 60’/30’/15’, 37 2 Shelf life: 12 months 104B HSV 2 IgG EIA (semi-quantitative) New test! Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 60’/30’/15’, 37 2 Shelf life: Normal range (K value): 12 months 5 Chlamydia IgG EIA (semi-quantitative) Sample type: Sample volume: serum, plasma 20 l Incubation: Control samples: 30’/30’/15’, 37 °C 3

12 Shelf life: Normal range (K value): 12
Shelf life: Normal range (K value): 12 months 5 Chlamydia IgM EIA New test! Sample type: Sample volume: serum, plasma 10 l Incubation: 30’, 37°C/30’/15’, 18-25 °C Control samples: Shelf life: 2 12 months Mycoplasma IgG EIA (semi-quantitative) Sample type: Sample volume: serum, plasma 20 l Incubation: Control samples: 30’/30’/15’, RT 3 Shelf life: Normal range (K value): 12 months 4 Treponema pallidum Total Ab EIA A solid-phase enzyme immunoassay for the qualitative detection of total antibodies (IgG, IgM, IgA) to Treponema pallidum in serum or plasma. Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 30’/15’, 37 2 Shelf life: 12 months Treponema pallidum IgG EIA A solid-phase enzyme immunoassay for the qualitative detection of IgG antibodies to Treponema pallidum inserum or plasma. Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 30’/30’/15’, 37 2 Shelf life: 12 months H. pylori IgG EIA (semi-quantitative) New test! Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 30’/30’/15’, 37 °C 2 Shelf life: Normal range (K value): 12 months 5 H. pylori IgM EIA (semi-quantitative) New test! Sample type: Sample volume: serum, plasma 10 l Incubation: Control samples: 30’/30’/15’, 37 °C 2 Shelf life: Normal range (K value): 12 months 5 Aspergillus IgG EIA (semi-quantitative) Sample type: Sample predilution: Sample volume: serum, plasma 1:21 100 l Incubation: Control samples: 30’/30’/15’, RT 3 Shelf life: Normal range (K value): 12 months 5 13 Ureaplasma IgG EIA (semi-quantitative) New test! Sample type: Sample volume: serum, plasma 20 l Incubation: Control samples: 30’/30’/15’, 37 °C 2 Shel

13 f life: 12 months Giardia lamblia Tot
f life: 12 months Giardia lamblia Total Ab EIA (semi-quantitative) New test! Sample type: Sample volume: serum, plasma 20 l Incubation: Control samples: 30’/30’/15’, 37 °C 2 Shelf life: 12 months Coming soon: K111M Treponema pallidum IgM EIA Nematodes IgG EIA Cestodes IgG EIA Trematodes IgG EIA H UMORAL IMMUNITY AND ACUTE PHASE PROTEINS Total IgG EIA Sample type: Sample predilution: Sample volume: Serum, plasma, urine, saliva, cerebrospinal uid 1:1–1:5000 10–100 l Sensitivity: Incubation: Calibrators: 0.12 g/l 30’/30’/15’, 37 5 (0–25 g/l) Control sample: Shelf life: Normal range, g/l: – serum 1 12 months 9.0–20.0 Total IgA EIA Sample type: Sample predilution: Sample volume: Serum, plasma, urine, saliva, cerebrospinal uid 1:1–1:5000 10–100 l Sensitivity: Incubation: Calibrators: 0.12 g/l 30’/30’/15’, 37 5 (0–5 g/l) Control sample: Shelf life: Normal range, g/l: – serum 1 12 months 0.9–5.0 Total IgM EIA Sample type: Sample predilution: Sample volume: Serum, plasma, urine, saliva, cerebrospinal uid 1:1–1:5000 10–100 l Sensitivity: Incubation: Calibrators: 0.12 g/l 30’/30’/15’, 37 5 (0–10 g/l) Control sample: Shelf life: Normal range, g/l: – serum 1 12 months 0.7–3.7 Secretory IgA EIA (in saliva) Sample type: Sample predilution: Sample volume: Saliva, serum, urine etc. 1:51–1:501 5–100 l Sensitivity: Incubation: Calibrators: 1.2 g/ml 90’/30’/15’, 37 6 (0–400 g/ml) Control sample: Shelf life: Normal range, g/l: – serum – saliva – urine 1 12 months 1.6–5.0 57–260 0.5–2.7 K272*IgG2 EIA Sample type: Sample predilution: Sample volume: Serum 1:5000 100 l Sensitivity: Incubation: Calibrators: 0.12 g/l 30’/30&

14 #146;/15’, 37 6 (0–15 g/l) Con
#146;/15’, 37 6 (0–15 g/l) Control sample: Shelf life: Normal range, g/l: 1 12 months 1.0–7.5 *– the kit is made to order 14 K274*IgG4 EIA Sample type: Sample predilution: Sample volume: Serum 1:5000 100 l Sensitivity: Incubation: Calibrators: 0.02 g/l 30’/30’/15’, 37 5 (0–2.5 g/l) Control sample: Shelf life: Normal range, g/l: 1 12 months 0.1–1.2 *– the kit is made to order Ig L (free lambda light chains) EIA Sample type: Sample predilution: Sample volume: Serum, plasma, urine, cerebrospinal uid 1:1–1:101 10–40 l Sensitivity: Incubation: Calibrators: 0.1 g/ml 30’/30’/15’, 37 6 (0–15 g/ml) Control sample: Shelf life: Normal range, g/ml: 1 12 months 2–6 *– the kit is made to order Ig K (free kappa light chains) EIA Sample type: Sample predilution: Sample volume: Serum, plasma, urine, cerebrospinal uid 1:1–1:101 10–100 l Sensitivity: Incubation: Calibrators: 1.0 g/ml 30’/30’/15’, 37 6 (0–150 g/ml) Control sample: Shelf life: Normal range, g/ml: 1 12 months 6 – 13 *– the kit is made to order CRP ultra EIA Sample type: Sample predilution: Sample volume: serum, plasma 1:101 25 l Sensitivity: Incubation: Calibrators: 0.05 mg/l 30’/30’/15’, 37 6 (0–25 mg/l) Control sample: Shelf life: Normal range, mg/l: 1 12 months 0–5.0 15 QUALITY CONTROL SERA FOR IMMUNOASSAYS K Q AutoQon Auto-Thyroid Control, 3 level AutoQon controls are derived from autoimmune disease state plasmas. A set of control preparations containing normal, moderately elevated and signicantly elevated levels ofautoantibodies to thyroid antigens (thyroglobulin, thyroperoxidase and TSH-receptor). P resentation : lyophilized, 5 vials, 1 for each variant, 1.0 ml each Shelf-li

15 fe : 4 years K HormoQon Control, 2 lev
fe : 4 years K HormoQon Control, 2 level HormoQon controls are made from healthy donor sera with puried antigens added. A set of control preparations containing 2 levels (normal and signicantly elevated concentrations) ofhormones. Pr esentation : lyophilized, 2 level, 2 vials for each level, 2.0 ml each Shelf-life : 4 years K OmaQon Control, 2 level OmaQon controls are made from healthy donor sera with puried antigens added. A set of control preparations containing 2 levels (moderate and signicantly elevated concentrations) oftumor markers. Pr esentation : lyophilized, 2 level, 2 vials for each level, 2.0 ml each Shelf-life : 4 years KQ23PrenaQon Control, 2 level PrenaQon controls are made from healthy donor sera with puried antigens added. A set of control preparations containing 2 levels (normal and pathological concentrations) of trisomy 21 (Down syndrome) markers: HCG, AFP, Estriol, free beta-HCG, PAPP-A. Presentation : lyophilized, 2 level, 2 vials for each level, 1.0 ml each Shelf-life : 4 years 16 REAGENTS FOR IMMUNOCHEMISTRY, IMMUNOHISTOCHEMISTRY AND FLOW CYTOMETRY* Cat.No. Product name Intended use and comments Primary Antibodies Monoclonal antibodies for immunohistochemistry/immunocytochemistry/ow cytometry, presented in stabilizing buer and titered on standard sections. Shelf life – 12 months at +4°C. Unit: 0.5 ml vial with concentrated antibody. AH200 mAb anti-IgE epsilon for IHC Detection of IgE protein, mast cells in tissues and basophils by ow cytometry AH221 mAb anti-PSA total for IHC Detection of prostatic tumors AH222 mAb anti-CA125 for IHC Detection of ovarian and other adenocarcinomas AH224 mAb anti-CEA for IHC Detection of adenocarcinomas AH225 mAb anti-AFP for IHC Detection of primary hepatomas, embryonal cell tumors AH226 mAb anti-MUC1 for IHC Detection of mammary and other adenocarci

16 nomas Species specic detection kits
nomas Species specic detection kits for paran and cryostat sections The kits contain: ready to use Blocking solution for sections; Biotinylated anti-species antibodies; Streptavidin-HRPO conjugate; DAB substrate for 100 determinations; shelf life– 12 months at +4  °C KH301 Rabbit IHC detection set Detection of rabbit antibodies in IHC preparations KH302 Murine IHC detection set Detection of murine monoclonal antibodies in IHC preparations Auxillary reagents for IHC. Shelf life– at least, 2 years at 4°C. S005X PBS conc. for IHC 10x concentrate; pH=7.2; 120 ml S006X Citrate buer conc. for IHC 10x concentrate; pH=6.0; 120 ml S015X TRIS buer conc. for IHC 10x concentrate; pH=7.6; 120 ml SH022 Tween-HCl for IHC 0.1M HCl; 0.1% Tween-20; 120 ml SH025 Antibody dilution buer for IHC 120 ml SH301 Blocking solution for IHC (rabbit) 5 ml SH302 Blocking solution for IHC (murine) 5 ml *– the reagents are made to order. Head office in Russia apt. 2, bldg. 3, 3, The 4th Vosmogo Marta st., 125319, Moscow, RUSSIA Our oce: 48, 9th Parkovaya str., 105264 Moscow, RUSSIA Tel./Fax: +7 495 737 39 36, +7 495 737 00 40 redkin@xema-medica.com www.xema-medica.com XEMA Co. Ltd. (Ukraine) P.O. Box 101, 03022 Kiev, Ukraine; +38 044 521 3 521, +38 068 350 46 61 nauka@xema.com.ua XEMA China (Beijing) Co. Ltd. Technological Park Zhenxing Road No. 28, GreenTec Industrial Park, General Building No. 206, Changping District , Beijing, China; 0086-18811037805, 0086-010-81708776 china@xema-medica.com XEMA OY (Finland) Ratapihantie, 7, 54270 Vainikkala/Lappeenranta; +358 5 457 01 11, +358 44 508 10 59 eu@xema-medica.com XEMA MALAYSIA SDN. BHD. (Malaysia) #37, Jalan Bulan Bl, U5/BL, Bandar Pinggiran Subang Seksyen U5 40150 Shah Alam, Selangor Malaysia Tel. 60-30-7831 4083 redkin@xema-medica.com www.xema-medica.com redkin@xema-med