LISA SYNLAB Eesti OÜ akrediteerimistunnistusele nr M003 ANNEX to the accreditation certificate No M003 of SYNLAB Eesti OÜ
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1 LISA SYNLAB Eesti OÜ akrediteerimistunnistusele nr M003 ANNEX to the accreditation certificate No M003 of SYNLAB Eesti OÜ 1. Akrediteerimisulatus on: Accreditation scope is: I. Tallinna labor: 1. Kliiniline keemia * * Ensüüm-seotud immuunsorptsiooni meetod* Enzyme-linked immunosorbent assay (ELISA)* Kemiluminestsents-immunomeetria* Chemiluminescence immunoassay (CLIA)* Spektrofotomeetria/ Immuunturbidimeetria* *Spectrophotometry/ * Fluorestsents-immuunmeetod* Fluorescence-immunoassay (FIA)* Kaudne immunofluorestsentsmeetod * Indirect immunofluorescence (IF)*, plasma, plasma, plasma, uriin, plasma, urine JU-LAB-103 JU-LAB-104, JU-LAB-105, JU-LAB-151, JU-LAB-165 JU-LAB-106 JU-LAB-137 JU-LAB-147 JU-LAB-146 Hemogramm 5- osalise Hemogram with 5-part leukocyte differential count Erütrotsüütide settekiirus Erythrocyte sedimentation rate (ESR) Retikulotsüütide uuring Reticulocyte count T-helperrakkude (CD4) ja T- supressorrakkude (CD8) suhe T-helper/T suppressor lymphocyte ratio (CD4/CD8) Protrombiini aeg, INR Prothrombin Time Aktiveeritud osalise tromboplastiini aeg Activated Partial Thromboplastin Time Fibrinogeen Fibrinogen D-dimeerid D-dimer Kapillaarmikrofotomeetria Capillary microphotometry Koagulatsioon: fotooptiline meetod Coagulation: photo-optical method Uuritav materjal Tested JU-LAB-102 JU-LAB-124 JU-LAB-174 JU-LAB-101 JU-LAB-182
2 Leht/Page 2/11 Glükohemoglobiin Glycated hemoglobin Inimese hemoglobiin (peitveri) roojas, kvantitatiivne Faecal blood, quantitative i ribaanalüüs strip test i analüüs test Süsivesikdefitsiitne transferrin Carbohydrate-deficient transferrin Kaalium Potassium Kloriid Chloride Naatrium Sodium Ioniseeritud kaltsium Ionized calcium 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 Spektrofotomeetria / immuunturbidimeetria Spectrophotometry/ immuunturbidimetry Immuunturbidimeetria (Quick ReadGo) värvusreaktsiooni Kapillaarelektroforees Capillary electrophoresis Potentsiomeetria Potentiometry Potentsiomeetria Potentiometry Fluorestsentsimmuunmeetod (DelfiaXpress6000) Fluorescenceimmunoassay Uuritav materjal Tested Roe Faeces JU-LAB-183 JU-LAB-175 JU-LAB-129 JU-LAB-158 JU-LAB-160 JU-LAB-117 JU-LAB-117 JU-LAB-117 JU-LAB-100 JU-LAB-164 JU-LAB-164 JU-LAB Toksikoloogia Toxicology Amfetamiin, Barbituraadid, Bensodiasepiinid, Buprenorfiin, Fentsüklidiin, Kannabinoidid, Kokaiin, Metadoon, Opiaadid, Propoksüfeen Amphetamines, Barbiturate, Benzodiazepine, Buprenprphine, Cannabinoids, Cocaine, Methadone, Opiates, Propoxyphene Ensümaatiline immuunmeetod Enzyme multiplied immuneassay technique (EMIT) Uuritav materjal Tested JU-LAB-185
3 Leht/Page 3/11 3. Immunohematoloogia Immunohaematology Veregrupid ABO ja Rh(D) group and Rh(D) Aglutinatsioon Agglutination Uuritav materjal Tested JU-LAB-131 Veregrupp ja Rh(D) group and Rh(D) Kolonn aglutinatsioon Column agglutination JU-LAB-184 Vastsündinu veregrupid ABO ja Rh(D) group ABO and Rh(D) for newborn Erütrotsüütide vastased antikehad Erythrocytic antibodies Erütrotsüütide vastased antikehad (kaudne Coombsi test) Erythrocytic antibodies (Indirect Coombs test) Otsene Coombsi test Direct Coombs test Aglutinatsioon Agglutination Aglutinatsioon Agglutination Kolonn aglutinatsioon Column agglutination JU-LAB-132 JU-LAB-133 JU-LAB-184 Kolonn aglutinatsioon Column agglutination JU-LAB-184 Katsete eest vastutaja / Responsible: Meeli Glükmann, Kliinilise laboridiagnostika valdkonna juht 4. Tsütoloogia Cytology Günekotsütoloogiline uuring Gynecocytological test Papanicolaou meetod Papanicolaou method Rakuline materjal emakakaelalt ja emakakaelakanalist Cellular from the cervix and cervical canal Katsete eest vastutaja / Responsible: Kristina Kööts, Patoloogia üksuse juht JU-LAB-122
4 Leht/Page 4/11 3. Mikrobioloogia Microbiology Aeroobsed bakterid* Aerobic bacteria* Anaeroobsed bakterid Anaerobic bacteria Salmonella Shigella Campylobacter Yersinia EHEC Seened (pärm- ja hallitusseened) Fungi (yeast and molds) Dermatofüüdid Dermatophytes Parasiidid* Parasites* Schistosoma haematobium Haigustekitajad* Pathogens Antibakteriaalne tundlikkus* Antimicrobial susceptibility* Külv söötmetele, inkubeerimine ja kasvu Culture to the medium, incubation and growth assessment Külv söötmetele, inkubeerimine ja kasvu Culture to the medium, incubation and growth assessment Algmaterjali mikroskoopia The basic for microscopy Külv söötmetele, inkubeerimine ja kasvu Culture to the medium, incubation and growth assessment Külv söötmetele, inkubeerimine ja kasvu Culture to the medium, incubation and growth assessment Külv söötmetele, inkubeerimine ja kasvu Culture to the medium, incubation and growth assessment Formaliinetüülatsetaat kontsentratsiooni meetod Formaline ethylacetate concentration method Mikroskoopia Microscopy Immunokromatograafia Immunochromatography Diskdifusiooni meetod Disk diffusion method Gradientmeetod Gradient method Puljong-lahjendusmeetod Phoenix süsteemiga Broth- dilution method with Phoenix system Roe, rektaalakaabe Stool, rectal swab Nahakaabe, küünekaabe, juuksed Skin, hair, nail Bakteri kultuur Bacterial culture Bakteri kultuur Bacterial culture Bakteri kultuur Bacterial culture JU-LAB-115 JU-LAB-116 JU-LAB-163 JU-LAB-18 JU-LAB-181 JU-LAB-169 JU-LAB-178 JU-LAB-112 JU-LAB-161 JU-LAB-114 JU-LAB-113 JU-LAB-113 JU-LAB-162
5 Leht/Page 5/11 Mikroorganismi samastamine Identification of the microorganism Mass-spektromeetria (MALDI-TOF MS) Mass-spectrometry Biokeemilise aktiivsuse ja immunoloogiliste markerite määramine Determination of biochemical activity and immunological markers Mikroskoopia Microscopy Mikroobi kultuur Microbial culture Mikroobi kultuur Microbial culture Mikroobi kultuur Microbial culture JU-LAB-177 JU-LAB-179 JU-LAB-18 A, B-gripiviiruse ja HRS viiruse RNA A, B influenza and RS-virus RNA Bordetella pertussis, Bordetella parapertussis/ bronchiseptica DNA Bordetella pertussis, Bordetella parapertussis/ bronchiseptica DNA Chlamydophila pneumoniae/mycoplasma pneumoniae DNA Chlamydophila pneumoniae/mycoplasma pneumoniae DNA Borrelia burgdorferi DNA Borrelia burgdorferi DNA MRSA DNA Clostridium difficile DNA Hepatiit B viiruse DNA Hepatitis B virus DNA Haigustekitaja DNA* Pathogen DNA* Reaal-aja PCR Real-Time PCR PCR ja hübridisatsioonimeetod, Luminex xmap tehnoloogia PCR and hybridization, Luminex xmap technology Ninaneelukaabe, kurgukaabe Nasopharyngeal swab, throat swab Ninaneelukaabe, ninaneeluaspiraat, kurgukaabe Nasopharyngeal swab, nasopharyngeal aspirate, throat swab Ninaneelukaabe Nasopharyngeal swab Biopsia, liikvor, liigesevedelik, puuk Biopsy, cerebrospinal fluid, synovial fluid, tick Bakteri kultuur Bacterial culture Roe, rektaalkaabe, bakteri kultuur Stool, rectal swab, bacterial culture,, JU-LAB-166 JU-LAB 138 JU-LAB 139 JU-LAB 141 JU-LAB 154 JU-LAB-170 JU-LAB-156 JU-LAB-140
6 Leht/Page 6/11 Hepatiidi C viiruse genotüüp Hepatitis C virus genotype Hepatiidi C viiruse RNA kvant Hepatitis C virus RNA QN Inimese immuunpuudulikkuse viiruse 1. tüübi RNA hulk plasmas (HIV RNA kvant) Human immunodeficiency virus type 1. RNA QN Chlamydia trachomatis RNA Chlamydia trachomatis RNA Inimese papilloomiviiruse RNA, kõrge riskiga genotüüp (HPV RNA) Human papilloma virus RNA, high risk genotype Neisseria gonorrhoeae RNA Neisseria gonorrhoeae RNA RT-PCR ja hübridisatsioonimeetod, Luminex xmap tehnoloogia RT-PCR and hybridization, Luminex xmap technology Real-time TMA-Transcription Mediated Amplification (Hologic Panther system) Real-time TMA-Transcription Mediated Amplification (Hologic Panther system) TMA Transcription Mediated Amplification (Hologic Panther system) TMA Transcription Mediated Amplification (Hologic Panther system) TMA Transcription Mediated Amplification (Hologic Panther system) EDTA plasma EDTA plasma,, EDTA plasma EDTA plasma, ureetrakaabe, tupekaabe, emakakaelakanalikaabe, urethra-, vaginal-, cervical canal Emakakaelakanali kaabe Cervical canal, ureetrakaabe, tupekaabe, emakakaelakanalikaabe, urethra-, vaginal-, cervical canal Katsete eest vastutaja / Responsible: Paul Naaber, Infektsioonhaiguste valdkonna juht JU-LAB-173 JU-LAB-171 JU LAB-171 JU-LAB-171 JU LAB-171 JU LAB Geneetika Genetics 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 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 EDTA veri EDTA blood EDTA veri, suulimaskestakaabe EDTA blood, buccal swab EDTA veri EDTA blood JU-LAB-145 JU-LAB-145 JU-LAB-152 Katsete eest vastutaja / Responsible: Kaspar Ratnik, Molekulaarbioloogia vastutav spetsialist
7 Leht/Page 7/11 II. Tartu labor: Hemogramm 5- osalise Hemogram with 5-part leukocyte differential i ribaanalüüs strip test Inimese hemoglobiin (peitveri) roojas, kvantitatiivne Faecal blood, quantitative Protrombiini aeg, INR Prothrombin Time Aktiveeritud tromboplastiini aeg Activated Partial Thromboplastin Time Erütrotsüütide settekiirus Erythrocyte sedimentation rate (ESR) Veregrupid ABO ja Rh(D) group and Rh(D) 1. Kliiniline keemia Spektrofotomeetria/ Immuunturbidimeetria* Spectrophotometry /* Electro-optical colorimetry Immuunturbidimeetria (Quick ReadGo) Koagulatsioon: fotooptiline meetod Coagulation: photooptical method Kapillaarmikrofotomeetria Capillary microphotometry Aglutinatsioon Agglutination Uuritav materjal Tested, plasma, plasma Roe Faeces JU-LAB-106 JU-LAB-118 JU-LAB-129 JU-LAB-175 JU-LAB-174 JU-LAB-131 Erütrotsüütide vastased antikehad Erythrocytic antibodies Aglutinatsioon Agglutination JU-LAB-133
8 Leht/Page 8/11 III. Jõhvi labor: Kliiniline keemia Hemogramm 5-osalise Hemogram with 5-part i ribaanalüüs strip test Electro-optical colorimetry, plasma,, plasma, JU-LAB-118 Katsete eest vastutaja / Responsible: Meeli Glükmann, Kliinilise laboridiagnostika valdkonna juht IV. Narva labor: Kliiniline keemia Hemogramm 5- osalise Hemogram with 5-part i ribaanalüüs strip test, plasma,, plasma, JU-LAB-118 Katsete eest vastutaja / Responsible: Meeli Glükmann, Kliinilise laboridiagnostika valdkonna juht V. Viljandi labor: Kliiniline keemia Hemogramm 3-osalise Hemogram with 3-part i ribaanalüüs strip test, plasma,, plasma, JU-LAB-155
9 Leht/Page 9/11 VI. Võru labor: Hemogramm 3- osalise Hemogram with 3-part i ribaanalüüs strip test Kliiniline keemia, plasma,, plasma, JU-LAB-155 VII. Pärnu labor: Hemogramm 3- osalise Hemogram with 3-part i ribaanalüüs strip test Protrombiini aeg, INR Prothrombin Time Kliiniline keemia Koagulatsioon-meetod (siemens BFT III) Coagulation, plasma,, plasma, plasma JU-LAB-155 JU-LAB-129 JU-LAB-167 VIII Elva labor: Hemogramm 3- osalise Hemogram with 3-part i ribaanalüüs strip test Kliiniline keemia JU-LAB-155
10 Leht/Page 10/11 IX Põltsamaa labor: Kliiniline keemia Hemogramm 3- osalise Hemogram with 3-part i ribaanalüüs strip test, plasma,, plasma, JU-LAB-155 * 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
11 Leht/Page 11/11 4. Katsetamist teostav struktuuriüksus: SYNLAB Eesti OÜ Part of legal entity that provides testing/measurement: Laborite asukohad Laboratories 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 Verevõtupunktide asukohad Collecting rooms addresses: Veerenni 53a, Tallinn Teguri 37b, Tartu Turu 2, 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 5. 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 the extension of accreditation scope Kristiina Saarniit EAK juhataja Director of EAK Tallinn, Kaire Tõugu Peaassessor Lead Assessor
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