
Region Gävleborg
Accreditation no: 1421
- Postal address:
- `, 801 88 Gävle
- Visiting address:
- Rektorsgatan 1, 802 50 Gävle · Show on map
Medical testing, SS-EN ISO 15189:2022
Latest decision date: 2025-06-27
| Teknikområde | Metod/utrustning | Provtyp/System/Provmaterial | Parameter/Analys/Process/Undersökning | Mätprincip | Flex | Business unit |
|---|---|---|---|---|---|---|
| Coagulation | Stago STA | Human kroppsvätskor | Biochemical markers | Koagulationstidsmätning | ||
| Coagulation | Stago STA | Human kroppsvätskor | Biochemical markers | Photometers | ||
| Coagulation | Stago STA | Human kroppsvätskor | Biochemical markers | Turbidimeters | ||
| Endocrinology | Roche Cobas | Human kroppsvätskor | Biochemical markers | CLIA | ||
| Endocrinology | Roche Cobas | Human kroppsvätskor | Biochemical markers | Turbidimeters | ||
| General chemistry | HemoCue Glucose | Human kroppsvätskor | Biochemical markers | Photometers | ||
| General chemistry | Roche Cobas | Human kroppsvätskor | Biochemical markers | CLIA | ||
| General chemistry | Roche Cobas | Human kroppsvätskor | Biochemical markers | Photometers | ||
| General chemistry | Roche Cobas | Human kroppsvätskor | Biochemical markers | Potentiometry | ||
| General chemistry | Roche Cobas | Human kroppsvätskor | Biochemical markers | Turbidimeters | ||
| General chemistry | Siemens DCA Vantage | Human kroppsvätskor | Biochemical markers | Turbidimeters | ||
| Hematology | HemoCue Hb | Human kroppsvätskor | Biochemical markers | Photometers | ||
| Hematology | Sysmex XN | Human kroppsvätskor | Biochemical markers | Beräknad | ||
| Hematology | Sysmex XN | Human kroppsvätskor | Biochemical markers | Flow cytometry | ||
| Hematology | Sysmex XN | Human kroppsvätskor | Biochemical markers | Impedansmätning | ||
| Hematology | Sysmex XN | Human kroppsvätskor | Biochemical markers | Photometers | ||
| Protein Chemistry | Roche Cobas | Human kroppsvätskor | Biochemical markers | CLIA | ||
| Protein Chemistry | Roche Cobas | Human kroppsvätskor | Biochemical markers | Turbidimeters | ||
| Protein Chemistry | Sebia Hydrasys | Human kroppsvätskor | Biochemical markers | Elektrofores | ||
| Protein Chemistry | Siemens Atellica | Human kroppsvätskor | Biochemical markers | Nephelometers |
| Metod/utrustning | Provtyp/System/Provmaterial | Parameter/Analys/Process/Undersökning | Mätprincip | Flex | Business unit |
|---|---|---|---|---|---|
| Biocartis Idylla | DNA | Detection of sequence variants | Real-time PCR | ||
| Roche BenchMark ULTRA | DNA | Detektion av kopietalsvariation | SISH | ||
| Roche cobas z 480 | DNA | Detection of sequence variants | Genotyping | ||
| Roche MagNa Pure 96 | Human material | Sample preparation | Extraction of DNA |
| Teknikområde | Metod/utrustning | Provtyp/System/Provmaterial | Parameter/Analys/Process/Undersökning | Mätprincip | Flex | Business unit |
|---|---|---|---|---|---|---|
| Clinical immunology | Roche cobas pro | Human kroppsvätskor | Detektion av antikroppar | ECLIA | ||
| Clinical immunology | Roche cobas pro | Human kroppsvätskor | Detektion av antikroppar | Turbidimeters | ||
| Clinical immunology | Thermo Fisher Phadia 250 | Human kroppsvätskor | Detektion av antikroppar | EIA | ||
| Clinical immunology | Thermo Fisher Phadia 250 | Human kroppsvätskor | Proteins | EIA | ||
| Transfusion medicine | - | Human kroppsvätskor | Blood grouping | Direct agglutination technique | ||
| Transfusion medicine | - | Human kroppsvätskor | Blood grouping | Indirect agglutination technique | ||
| Transfusion medicine | - | Human kroppsvätskor | Compatibility testing | Direct agglutination technique | ||
| Transfusion medicine | - | Human kroppsvätskor | Compatibility testing | Indirect agglutination technique | ||
| Transfusion medicine | - | Human kroppsvätskor | Determination of erythrocyte antigen | Direct agglutination technique | ||
| Transfusion medicine | - | Human kroppsvätskor | Determination of erythrocyte antigen | Indirect agglutination technique | ||
| Transfusion medicine | Manual method; Mikrokolonn BIO-RAD Banjo avläsning | Human kroppsvätskor | Blood grouping | Direct agglutination technique | ||
| Transfusion medicine | Manual method; Mikrokolonn BIO-RAD Banjo avläsning | Human kroppsvätskor | Compatibility testing | Direct agglutination technique | ||
| Transfusion medicine | Manual method; Mikrokolonn BIO-RAD Banjo avläsning | Human kroppsvätskor | Compatibility testing | Indirect agglutination technique | ||
| Transfusion medicine | Manual method; Mikrokolonn BIO-RAD Banjo avläsning | Human kroppsvätskor | Direct antiglobulin test (DAT) | Direct agglutination technique | ||
| Transfusion medicine | QuidelOrtho ORTHO VISION Analyzer | Human kroppsvätskor | Blood grouping | Direct agglutination technique | ||
| Transfusion medicine | QuidelOrtho ORTHO VISION Analyzer | Human kroppsvätskor | Blood grouping | Indirect agglutination technique | ||
| Transfusion medicine | QuidelOrtho ORTHO VISION Analyzer | Human kroppsvätskor | Compatibility testing | Direct agglutination technique | ||
| Transfusion medicine | QuidelOrtho ORTHO VISION Analyzer | Human kroppsvätskor | Compatibility testing | Indirect agglutination technique | ||
| Transfusion medicine | QuidelOrtho ORTHO VISION Analyzer | Human kroppsvätskor | Determination of erythrocyte antigen | Direct agglutination technique | ||
| Transfusion medicine | QuidelOrtho ORTHO VISION Analyzer | Human kroppsvätskor | Determination of erythrocyte antigen | Indirect agglutination technique |
| Teknikområde | Metod/utrustning | Provtyp/System/Provmaterial | Parameter/Analys/Process/Undersökning | Mätprincip | Flex | Business unit |
|---|---|---|---|---|---|---|
| Clinical bacteriology | Standard method | Främmande kroppsmaterial | Detektion av relevanta bakterier | Odling | ||
| Clinical bacteriology | Standard method | Human material | Antigen detection | EIA | ||
| Clinical bacteriology | Standard method | Human material | Detektion av antikroppar | CLIA | ||
| Clinical bacteriology | Standard method | Human material | Detektion av antikroppar | EIA | ||
| Clinical bacteriology | Standard method | Human material | Detektion av relevanta bakterier | Microscopic diagnostics | ||
| Clinical bacteriology | Standard method | Human material | Detektion av relevanta bakterier | Odling | ||
| Clinical bacteriology | Standard method | Human material | Detektion av relevanta bakterier | Real-time PCR | ||
| Clinical bacteriology | Standard method | Human material | Detektion av specifika gener | Real-time PCR | ||
| Clinical bacteriology | Standard method | Human material | Identifikation | MALDI-TOF | ||
| Clinical bacteriology | Standard method | Human material | Resistensbestämning | Diskdiffusion | ||
| Clinical bacteriology | Standard method | Human material | Resistensbestämning | Odling | ||
| Clinical bacteriology | Standard method | Human material | Resistensbestämning | Real-time PCR | ||
| Clinical bacteriology | Standard method | Isolate | Resistensbestämning | Diskdiffusion | ||
| Clinical bacteriology | Standard method | Isolate | Resistensbestämning | Gradienttest | ||
| Clinical bacteriology | Standard method | Isolate | Resistensbestämning | Odling | ||
| Clinical bacteriology | Standard method | Isolate | Resistensbestämning | Real-time PCR | ||
| Clinical virology | BD BD MAX | Human kroppsvätskor | Virus DNA and RNA | Real-time PCR | ||
| Clinical virology | Cepheid GeneXpert GX-II | Human kroppsvätskor | Virus DNA and RNA | Real-time PCR | ||
| Clinical virology | Cepheid GeneXpert GX-IV | Human kroppsvätskor | Virus DNA and RNA | Real-time PCR | ||
| Clinical virology | Cepheid GeneXpert GX-XVI | Human kroppsvätskor | Virus DNA and RNA | Real-time PCR | ||
| Clinical virology | Roche cobas 6800 | Human kroppsvätskor | Virus DNA and RNA | Real-time PCR | ||
| Clinical virology | Roche cobas pro | Human kroppsvätskor | Antigen detection | ECLIA | ||
| Clinical virology | Roche cobas pro | Human kroppsvätskor | Detektion av antikroppar | ECLIA |
| Teknikområde | Provtyp/System/Provmaterial | Parameter/Analys/Process/Undersökning | Mätprincip | Flex | Business unit |
|---|---|---|---|---|---|
| Morphological Diagnostics | Cells | Exfoliativ cytologi cervixcytologi | Microscopic diagnostics | ||
| Morphological Diagnostics | Tissue | - | Digital image diagnostics | ||
| Morphological Diagnostics | Tissue | - | Microscopic diagnostics | ||
| Morphological Diagnostics | Tissue | Bröstdiagnostik | Digital image diagnostics | ||
| Morphological Diagnostics | Tissue | Bröstdiagnostik | Microscopic diagnostics | ||
| Morphological Diagnostics | Tissue | Gastrointestinal diagnostik appendix | Digital image diagnostics | ||
| Morphological Diagnostics | Tissue | Gastrointestinal diagnostik appendix | Microscopic diagnostics | ||
| Morphological Diagnostics | Tissue | Gastrointestinal diagnostik duodenum | Digital image diagnostics | ||
| Morphological Diagnostics | Tissue | Gastrointestinal diagnostik duodenum | Microscopic diagnostics | ||
| Morphological Diagnostics | Tissue | Gastrointestinal diagnostik ventrikel, icke tumörsjukdomar | Digital image diagnostics | ||
| Morphological Diagnostics | Tissue | Gastrointestinal diagnostik ventrikel, icke tumörsjukdomar | Microscopic diagnostics |
| Teknikområde | Metod/utrustning | Provtyp/System/Provmaterial | Parameter/Analys/Process/Undersökning | Mätprincip | Flex | Business unit |
|---|---|---|---|---|---|---|
| Alcohol analyses | Sebia Capillarys 3 Tera | Human kroppsvätskor | Alcohols | - | ||
| Drug analysis | Roche cobas pro | Human kroppsvätskor | Pharmaceuticals | KIMS | ||
| Drug analysis | Roche cobas pro | Human kroppsvätskor | Pharmaceuticals | Photometers | ||
| Drug analysis | Roche cobas pure | Human kroppsvätskor | Pharmaceuticals | KIMS | ||
| Drug analysis | Roche cobas pure | Human kroppsvätskor | Pharmaceuticals | Photometers |
| Teknikområde | Provtyp/System/Provmaterial | Flex | Business unit |
|---|---|---|---|
| Sampling | Human material |
- The accredited body has been granted flexible scope. The body shall be able to provide an updated list of the current scope of accreditation upon request.
Regulations
- STAFS 2020:1
- Swedacs föreskrifter och allmänna råd om ackreditering