EESTI AKREDITEERIMISKESKUS ESTONIAN ACCREDITATION CENTRE
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1 1 (10) 1. Akrediteerimisulatus on alljärgnev: Accreditation scope is the following: EESTI AKREDITEERIMISKESKUS ESTONIAN ACCREDITATION CENTRE Lisa SYNLAB Eesti OÜ akrediteerimistunnistusele L159 ANNEX to the accreditation certificate L159 of SYNLAB Eesti OÜ I. Tallinna labor: 1. Kliiniline keemia * * Ensüüm-seotud immuunsorptsiooni meetod* Enzyme-linked immunosorbent assay* Kemiluminestsents-immunomeetria* Chemiluminescence immunometry* Spektrofotomeetria/ Immuunturbidimeetria* *Spectrophotometry/ Immunoturbidimetry* Fluorestsents-immuunmeetod* Fluorescence-immunoassay* Kaudne immunofluorestsentsmeetod (IF)* Indirect immunofluorescence*, plasma, plasma, plasma, uriin, plasma, urine , 105, 151, Retikulotsüütide uuring Reticulocyte count Hemogramm 5- osalise Hemogram with 5-part leukocyte differential count Erütrotsüütide settekiirus Erythrocyte sedimentation rate (ESR) i analüüs test Kapillaarmikrofotomeetria Capillary microphotometry Elektro-optiline värvusreaktsiooni hindamine Electro-optical colorimetry Flow cytometry
2 2 (10) Inimese hemoglobiin (peitveri) roojas, kvantitatiivne Faecal blood, quantitative Protrombiini aeg, INR Prothrombin Time Aktiveeritud osalise tromboplastiini aeg Activated Partial Thromboplastin Time Fibrinogeen Fibrinogen D-dimeerid D-dimer Kaalium Potassium Kloriid Chloride Naatrium Sodium Ioniseeritud kaltsium Ionized calcium Süsivesikdefitsiitne transferrin Carbohydrate-deficient transferrin Platsenta kasvufaktor (PLGF) Placental growth factor Rasedusega seotud plasma proteiin A (PAPP-A) Pregnancy-associated plasma protein A Vaba beeta HCG Free beta human chorionic gonadotrophin Immuunturbidimeetr ia (Quick ReadGo) Immunoturbidimetry Koagulatsioon: fotooptiline meetod Coagulation: photooptical method Potentsiomeetria Potentiometry Kapillaarelektroforees Capillary electrophoresis Fluorestsentsimmuunmeetod (DelfiaXpress6000) Fluorescenceimmunoassay Roe Faeces Mõõteulatus Range (15 200) µg/g INR (0,77 5,0) (15 120) s (0,8 8,9) g/l ( ) ng FEU/ml (1 10) mmol/l (15 200) mmol/l ( ) mmol/l (0,2 5,0) mmol/l (0,3 26,2) % (3,3 4000) pg/ml (0,015 10) IU/L (0,3 200) IU/L
3 2. Immunohematoloogia valdkond Immunohaematology Veregrupid ABO ja Rh(D) Veri group and Rh(D) Vastsündinu veregrupid ABO ja Rh(D) group ABO and Rh(D) for newborn Veri 3 (10) Vastus Result AB0 veregrupp: 0/A/B/AB/Selguseta Rh(D) kuuluvus: /Selguseta AB0 veregrupp: 0/A/B/AB/Selguseta Rh(D) kuuluvus: /Selguseta DAT: Negatiivne / Erütrotsüütide vastased antikehad Erythrocytic antibodies Veri 133 Katsete eest vastutaja / Responsible: Meeli Glükmann, Kliinilise laboridiagnostika valdkonna juht 3. Mikrobioloogia Microbiology Aeroobsed bakterid* Aerobic bacteria* Anaeroobsed bakterid Anaerobic bacteria Seened (pärm- ja hallitusseened) Fungi (yeast and molds) Parasiidid* Parasites* Haigustekitajad* Pathogens Külv söötmetele, inkubeerimine ja kasvu hindamine Culture to the medium, incubation and growth assessment Külv söötmetele, inkubeerimine ja kasvu hindamine Culture to the medium, incubation and growth assessment Algmaterjali mikroskoopia The basic material for microscopy Külv söötmetele, inkubeerimine ja kasvu hindamine Culture to the medium, incubation and growth assessment Formaliinetüülatsetaat kontsentratsiooni meetod Formaline ethylacetate concentration method Immunokromatograafia Immunochromatography
4 4 (10) Antibakteriaalne Diskdifusiooni meetod Bakteri kultuur tundlikkus* Disk diffusion method Bacterial culture Antimicrobial Gradientmeetodil Bakteri kultuur susceptibility* Gradient method Bacterial culture Puljong-lahjendusmeetod Phoenix Bakteri kultuur süsteemiga Bacterial culture Broth- dilution method with Phoenix system Mikroorganismi Mass-spektromeetria Mikroobi kultuur samastamine (MALDI-TOF MS) Microbial culture Identification of the Mass-spectrometry micro-organism Biokeemilise aktiivsuse ja Mikroobi kultuur immunoloogiliste markerite Microbial culture määramine Determination of biochemical activity and immunological markers Mikroskoopia Mikroobi kultuur Microscopy Microbial culture Katsete eest vastutaja / Responsible: Paul Naaber, Infektsioonhaiguste valdkonna juht 4. Tsütoloogia Cytology Günekotsütoloogiline uuring Gynecocytological test Papanicolaou meetod Papanicolaou method Rakuline materjal emakakaelalt ja emakakaelakanalist Cellular material from the cervix and cervical canal Katsete eest vastutaja / Responsible: Kristina Kööts, Tsütoloogia üksuse juht Molekulaarbioloogia Molecular biology A, B-gripiviiruse ja HRS viiruse RNA A, B influenza and RSvirus RNA Bordetella pertussis, Bordetella parapertussis/ bronchiseptica DNA Bordetella pertussis, Bordetella parapertussis/ bronchiseptica DNA Reaal-aja PCR Real-Time PCR Polümeraasahelreaktsioon (PCR) Polymerase chain reaction (PCR) Ninaneelukaabe, 166 kurgukaabe Nasopharyngeal swab, throat swab Ninaneelukaabe, JU-LAB 138 ninaneeluaspiraat, kurgukaabe Nasopharyngeal swab, nasopharyngeal aspirate, throat swab Vastus Result positiivne
5 5 (10) Borrelia burgdorferi Polümeraasahelreaktsioon DNA Borrelia burgdorferi (PCR) DNA Polymerase chain reaction (PCR Hepatiit B viiruse Polümeraasahelreaktsioon genotüüp Hepatitis B virus Polymerase chain genotype reaction (PCR) Hepatiidi C viiruse RNA RT-PCR kvant (reverse Hepatitis C virus RNA QN transcription PCR) Hepatiidi C viiruse TMA-transription genotüüp Mediated Hepatitis C virus Amplification genotype (Hologic Panther Chlamydophila pneumoniae/mycoplasma pneumoniae DNA Chlamydophila pneumoniae/mycoplasma pneumoniae DNA Chlamydia trachomatis RNA Chlamydia trachomatis RNA HLA-B27 alleel HLA-B27 allele Hüpolaktaasia täiskasvanutel LCT geeni c c>t variant (LCT c C>T) Adult-type hypolactasia - LCT C>T polymorphism HLA DQ2, DQ8 riski alleelid system) Polümeraasahelreaktsioon Polymerase chain reaction (PCR) TMA-transription Mediated Amplification (Hologic Panther system) PCR ja hübridisatsioonimeetod, Luminex xmap tehnoloogia PCR and hybridization, Luminex xmap technology PCR ja hübridisatsioonimeetod, Luminex xmap tehnoloogia PCR and hybridization, Luminex xmap technology Reaal-aja PCR Real-Time PCR Biopsia, liikvor, liigesevedelik, puuk Biopsy, cerebrospinal fluid, synovial fluid, tick,,,, EDTA plasma EDTA plasma Ninaneelukaabe Nasopharyngeal swab, ureetrakaabe, tupekaabe, emakakaelakanalikaabe, urethra-, vaginal-, cervical canal material EDTA veri EDTA blood EDTA veri, suulimaskesta-kaabe EDTA blood, buccal swab EDTA veri EDTA blood JU-LAB JU-LAB Vastus Result positiivne, genotüüp positiivne Kvantitatiiv ne tiiter positiivne Genotüüp T/T, T/C, C/C Alleeli leid
6 Inimese immuunpuudulikkuse viiruse 1. tüübi RNA hulk plasmas (HIV RNA kvant) Human immunodeficiency virus type 1. RNA QN Inimese papilloomiviiruse RNA, kõrge riskiga genotüüp (HPV RNA) Human papilloma virus RNA, high risk genotype Neisseria gonorrhoeae RNA Neisseria gonorrhoeae RNA TMA-transription Mediated Amplification (Hologic Panther system) TMA-transription Mediated Amplification (Hologic Panther system) TMA-transription Mediated Amplification (Hologic Panther system) 6 (10) Vastus Result EDTA plasma JU LAB-171 EDTA plasma Emakakaelakanali kaabe Cervical canal material, ureetrakaabe, tupekaabe, emakakaelakanalikaabe, urethra-, vaginal-, cervical canal material JU LAB-171 JU LAB-171 Vastus Result PCR ja hübridisatsioonimeetod, Luminex xmap tehnoloogia* PCR and hybridization, Luminex xmap technology* Erinevad materjalid* Different materials* 140 Katsete eest vastutaja / Responsible: Paul Naaber, Infektsioonhaiguste valdkonna juht II. Tartu labor: Hemogramm 5- osalise Hemogram with 5-part leukocyte differential 1. Kliiniline keemia Spektrofotomeetria/ Immuunturbidimeetria* Spectrophotometry /Immunoturbidimetry* Elektro-optiline kolorimeetria Electro-optical colorimetry, plasma, plasma
7 7 (10) Inimese hemoglobiin (peitveri) roojas, kvantitatiivne Faecal blood, quantitative Protrombiini aeg, INR Prothrombin Time Aktiveeritud tromboplastiini aeg Activated Partial Thromboplastin Time Kaalium Potassium Naatrium Sodium Immuunturbidi meetria (Quick ReadGo) Immunoturbidim etry Koagulatsioon: foto-optiline meetod Coagulation: photo-optical method Potentsiomeetria Potentiometry Roe Faeces, plasma, plasma Mõõteulatus Range (15 200) µg/g INR (0,77 5,0) (15 120) s (2,0 10) mmol/l ( ) mmol/l 2. Immunohematoloogia valdkond Immunohematology Vastus Result Veregrupid ABO ja Rh(D) group and Rh(D) Veri 131 AB0 veregrupp: 0 / A / B / AB / Selguseta Rh(D) kuuluvus: / Negatiivne / Selguseta Erütrotsüütide vastased Veri 133 antikehad Erythrocytic antibodies III. Jõhvi labor: Hemogramm 5- osalise Hemogram with 5-part Kliiniline keemia Elektro-optiline kolorimeetria Electro-optical colorimetry Immunoturbidimeetria Immunoturbidimetry, plasma,, plasma, Katsete eest vastutaja / Responsible: Meeli Glükmann, Kliinilise laboridiagnostika valdkonna juht
8 IV. Narva labor: Hemogramm 5- osalise Hemogram with 5-part Kliiniline keemia 8 (10) 118 Elektro-optiline kolorimeetria Electro-optical colorimetry 110 Immunoturbidimeetria Immunoturbidimetry, plasma,, plasma, 150 Katsete eest vastutaja / Responsible: Meeli Glükmann, Kliinilise laboridiagnostika valdkonna juht V. Viljandi labor: Kliiniline keemia Hemogramm 3-osalise Hemogram with 3-part Elektro-optiline kolorimeetria Electro-optical colorimetry Immunoturbidimeetria, plasma, Immunoturbidimetry, plasma, VI. Võru labor: Hemogramm 3- osalise Hemogram with 3-part Kliiniline keemia Elektro-optiline kolorimeetria Electro-optical colorimetry Immunoturbidimeetria, plasma, Immunoturbidimetry, plasma,
9 VII. Pärnu labor: Hemogramm 3- osalise Hemogram with 3-part Kliiniline keemia 9 (10) Elektro-optiline kolorimeetria Electro-optical colorimetry Immunoturbidimeetria, plasma, Immunoturbidimetry, plasma, Protrombiini aeg, INR Koagulatsioon-meetod Prothrombin Time (siemens BFT III) plasma VIII Elva labor: Kliiniline keemia Hemogramm 3- osalise Hemogram with 3-part Elektro-optiline kolorimeetria Electro-optical colorimetry IX Põltsamaa labor: Kliiniline keemia Hemogramm 3- osalise Hemogram with 3-part Elektro-optiline kolorimeetria Electro-optical colorimetry Immunoturbidimeetria, Immunoturbidimetry plasma,, plasma,
10 10 (10) * paindlik akrediteerimisulatus uuritava parameetri ja/või maatriksi osas on kirjeldatud labori dokumendis: Testide ja meetodite nimekiri SYNLAB Eesti * the range of flexible scope is described in the laboratory document The list tests and methods of SYNLAB Eesti 2. Katsetamist teostavad struktuuriüksused: Part of legal entity that provides testing/calibration: Laborite asukohad Laboratories addresses: Verevõtupunktide asukohad Collecting rooms addresses: Veerenni 53a, Tallinn Teguri 37b, Tartu Turu 8/10, Viljandi Jaama 34, Jõhvi Tallinna mnt 19c, Narva Jüri 19a, Võru Suur-Sepa 14, Pärnu Supelranna 21, Elva Lossi 49, Põltsamaa Veerenni 53a, Tallinn Teguri 37b, Tartu Gildi 8, Tartu Turu 8/10, Viljandi Jaama 34, Jõhvi Tallinna mnt 19c, Narva Jüri 19a, Võru Seedri 6, Pärnu Supelranna 21, Elva Lossi 49, Põltsamaa 3. Labor on akrediteeritud standardi EVS-EN ISO 15189:2012 nõuete suhtes Laboratory is accredited against the requirements of standard EVS-EN ISO 15189:2012 Märkus: käesolev lisa asendab väljaantud lisa seoses akrediteerimisulatuse laiendamisega. Note: this annex replaces the annex issued due to extension of accreditation scope. K. Saarniit K. Tõugu EAK juhataja Peaassessor Director Lead assessor Tallinn,
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