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NAAT tests (PCR and LAMP) at Oslo Helse

All molecular diagnostic test kits used at Oslo Helse are CE-IVD certified as required by European laws and regulations for in vitro diagnostics. Oslo Helse also uses Covid-19 nucleic acid amplification tests that are FDA approved in addition to CE-IVD certification. Prior to use, Kits and equipment are verified for use on-site by comparison of test results with other laboratories, other test devices, or external quality controls such as QCMD. Controls for testing that include primary samples that have not been extracted for RNA are used with new kit batch/lot number to ensure kit testing performance. Test kit manufacturer’s guidelines are always adhered to. Appropriate actions are taken in case of deviations from conformity. Tests are performed using guidelines set out by WHO (www-who- int.ezproxy.uio.no/...), as well as the national regulations and guidelines for laboratory testing, as published by the department of public health (www.fhi.no/nettpub/coronavirus/). The national laws and requirement for accreditation of laboratories and medical practices for SARS-CoV-2 specimen collection and diagnostic testing are followed. SARS-CoV-2 NAAT results from Oslo Helse has been accepted and recorded by the Norwegian Institute of public health (helsedata.no/no/forvaltere/folkehelseinstituttet...) and the information used by regional medical teams for contact tracing and outbreak management. Test results from Oslo Helse are available on the national registry of personal health records (helsenorge.no).

Specimen collection from patients, including Nasopharyngeal, oropharyngeal, and nasal are collected by qualified medical doctors that are certified to practice in Norway. Saliva and Mouthwash specimens are collected from patients by supervision from the same medical practitioners until the time unsupervised self-sampling for SARS-CoV-2 testing is approved by the local medical authorities. All specimens are collected, transported, and processed to meet the requirements of the kits used for NAATs.

Specimens are collected by medical doctors that are registered with the Norwegian Registration Authority for Health Personnel (www.helsedirektoratet.no/english/authorisation...). Specimens are processed by the same practitioners responsible for collection if necessary, prior to transport to the laboratory for diagnostic testing where NAATs are performed following the manufacturer’s instructions.

Antigen testing for SARS-CoV-2 at Oslo Helse

All antigen tests for SARS-CoV-2 used at Oslo Helse are CE-IVD certified as required by European laws and regulations for invitro diagnostics. The tests are also FDA approved and listed by the German Federal Institute for Drugs and Medical Devices (antigentest.bfarm.de/ords/...). Tests are performed using the manufacturers' instructions, guidelines set out by WHO (www-who-int.ezproxy.uio.no/emergencies/...), as well as the national regulations and guidelines for laboratory testing, as published by the department of public health (www.fhi.no/nettpub/coronavirus/). The national laws and requirement for accreditation of laboratories and medical practices for SARS-CoV-2 specimen collection and diagnostic testing are followed. SARS-CoV-2 antigen test results from Oslo Helse has been accepted and recorded by the Norwegian Institute of public health (helsedata.no/no/forvaltere/folkehelseinstituttet/...) and the information used by regional medical teams for contact tracing and outbreak management. Test results from Oslo Helse are available on the national registry of personal health records (helsenorge.no).

Specimen collection from patients for SARS-CoV-2 antigen testing is performed using WHO guidelines (www-who-int.ezproxy.uio.no/emergencies/diseases/...), as well as the national regulations and guidelines for laboratory testing, as published by the department of public health (www.fhi.no/nettpub/coronavirus/). Specimens are collected by medical doctors that are registered with the Norwegian medical board (www.helsedirektoratet.no/english/authorisation-and-license...). Saliva and Mouthwash specimens are collected from patients by supervision from the same medical practitioners until the time and if unsupervised self-sampling for SARS-CoV-2 testing is approved by the local medical authorities. Antigen tests are performed onsite using the manufacturer’s instructions.

Test results to individuals and authorities

The current national guidelines require private medical clinics to report all SARS-CoV-2 positive cases to the Norwegian Surveillance System for Communicable Diseases (MSIS). This is adhered to strictly.

Individuals receive test results with the following information in English. A Norwegian version of the test result is available to the individual upon request from the individual.

  1. Name of the individual as supplied by the individual and verified by inspection of his or her ID.
  2. Date of birth of the individual.
  3. The test procedure and that the target of the test is SARS-CoV-2 antigen.
  4. Sampling date and time.
  5. Source of specimen.
  6. The test result(s).
  7. Name, address and country of the institution, Oslo Helse, where the test is carried out.
  8. Statement of test kit validation.
  9. Name and signature of supervising medical doctor.

Glossary:

NAAT = Nucleic Acid Amplification Technology
PCR = Polymerase Chain Reaction
LAMP = Loop-Mediated Isothermal Amplification
WHO = World Health Organization
FHI = Folke Helse Instituttet (The Norwegian National Public health institute)

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