Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name National Virus Reference Laboratory INAB Reg No 326MT Contact Name Eimear Malone Address University College Dublin, Belfield, Dublin Contact Phone No Website Accreditation Standard ISO Date Initially Awarded 09/09/2014 Scope Classification Services available to the public¹ Microbiology and virology No ¹ Refer to document on interpreting INAB Scopes of Accreditation Sites from which accredited services are delivered (the detail of the accredited services delivered at each site are on the Scope of Accreditation) Name Address 1 Head Office University College Dublin, Belfield, Dublin, D4 INAB Registration No. 326MT Page 1 of 6 Edition 1, 12/10/2017

2 Scope of Accreditation Head Office Microbiology and Virology Category: A Medical pathology field - Test 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.05 Immunofluorescence 1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids -.03 Nucleic acid amplification tests, marked commercial systems Test/assay Specimen Type Equipment/Technique Method (/Non- /In house /based on standard method) Bartels Viral Abbott RealTime High Risk Human Papilloma Virus (HPV) Assay Aptima Human Papilloma Virus (HPV) Assay Aptima Trichomonas vaginalis (TV) assay CMV DNA Respiratory secretions ThinPrep liquid cytology specimens Aptima Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens: Aptima Urine Collection Kit for Male and Female Urine Specimens: Aptima Vaginal Swab Specimen Collection Kit /IF RealTime PCR based assay detectin HPV HR DNA. Run on the Abbott m2000. In vitro nucleic amplification test specific for HPV RNA. Run on the Genprobe TIGRIS DTS and Panther System In vitro qualitative nucleic acid amplification test for the detection of ribosomal RNA (rrna) from Trichomonas vaginalis using the TIGRIS DTS system marked with CT/NG Urine and swabs Tigris and Panther Detection of Viral Infections in the Central Nervous System including herpes viruses (HSV 1, HSV 2, VZV, Enterovirus, Parechovirus and HHV6) CSF INAB Registration No. 326MT Page 2 of 6 Edition 1, 12/10/2017

3 EBV DNA Gastroenteritis screen Faecal including:astrovirus, Sapovirus,Adenoviru s type F, Rotavirus, Norovirus (Genogroup 1&2) HCV Genotype 1antiviral resistance testing (including Q80K polymorphism analysis) NS3 gene HCV II Genotyping HCV RNA Hepatitis B Virus HIV-1 genotypic antiviral resistance testing (pol region) Immunodeficiency virus type 1 Influenza viruses A and B, Respiratory Syncytial virus, Human Metapnuemovirus, Adenovirus, Parainfluenza viruses 1,2,3,4 (P1,2,3,4) Parvovirus 1018 Detection of antibody TP-PA appropriate marked Adenovirus DNA BK virus DNA (Quantitative) Hepatitis A virus RNA Hepatitis E Virus Real-time PCR for Herpes Simplex 1 and 2 virus DNA Real-time PCR for JC Virus DNA Varicella Zoster DNA Real-Time RT-PCR for Enterovirus and Parechovirus RNA Whole Blood Serum and Plasma samples marked with Genetic Analyser 3500 Dx Abbott real time assay Abbott real time assay Abbott real time assay Plasma samples Genetic Analyser 3500 Dx Swabs/Respirator y samples/aspirate s Swabs, Stool Serum, Plasma, and Urine samples Abbott real time assay marked with and/or Viia 7 Taqman 7500 Serum Taqman 7500 marked with Swabs, CSF, Serum, Urine and Plasma Swabs, Taqman 7500 Taqman 7500 marked with Stool, Swab Taqman 7500 INAB Registration No. 326MT Page 3 of 6 Edition 1, 12/10/2017

4 .01 Particle agglutination, using marked commercial systems 1018 Detection of antibody Anti-HBc Vidas appropriate marked.02 Enzyme immunoassay, using marked commercial systems Anti-HCV Vidas CMV IgM Vidas Cytomegalovirus IgM Diasorin Enzyme Immunoassay for Qualitative determination of Total antibodies to Hepatitis Delta antigen (anti- D) Fortress HEV IgG Human serum Fortress HEV-IgM Genscreen Ultra HIV Ag/Ab HAV IgM Vidas Herpes Select 1 Human serum Herpes Select 2 HIV screening Vidas Leptospira IgM Human serum Liaison XL Anti-HBc assay Measles IgM Monolisa Anti-HBc Serum/Plasma and oral fluid Chemiluminescence immunoasssay (CLIA) technology for the qualitative determination of total antibodies to hepatitis B core antigen (anti- HBc) inhuman serum or samples Monolisa HCV Ab Mumps IgG Diasorin Liaison XL Mumps IgM Murex HBsAg Murex HBsAg Confirmatory and oral fluid Murex HTLV I/II Ortho HCV Syphillis IgM INAB Registration No. 326MT Page 4 of 6 Edition 1, 12/10/2017

5 Toxo IgG II Vidas Toxo IgM Vidas Vidas HIV 1 P24 11 Confirmatory Vidas 1018 Detection of antibody INNO-LIA HCV Score AUTO-LIA appropriate marked.04 Line immunoassay, using marked commercial systems INNO-LIA HIV I/11 Immunoblot INNO-LIA HTLV I/II Score AUTO-LIA 1018 Detection of antibody Anti-HBc IgM Architect i4000 appropriate marked.07 Chemiluminescent microparticle immunoassay, using marked commercial systems Anti-HBc II Architect i4000 Anti-HBe Architect i4000 Anti-HBs Architect i4000 Diasorin Liaison XL Anti-HCV Architect i4000 Borrelia IgG Diasorin Liaison XL CMV IgG Architect i4000 CMV IgM Architect i4000 EBNA IgG Diasorin Liaison XL EBV IgM Diasorin Liaison XL EBV VCA IgG Diasorin Liaison XL HAVAb-IgG Architect i4000 HAVAb-IgM Architect i4000 HBeAg Architect i4000 HBsAg Architect i4000 HCV Ag Architect i4000 HIV Ag/Ab Combo Architect i4000 HSV 1 / 2 IgG Human serum Diasorin Liaison XL Liaison XL Murex rechtlv-i/ii assay Serum/Plasma Chemiluminescence immunoasssay (CLIA) technology for the qualitative determination of specific antibodies to Human T-cell Lymphotropic Virus (HTLV) Type I and Type II (anti-htlv I and anti-htlv II) in human serum and INAB Registration No. 326MT Page 5 of 6 Edition 1, 12/10/2017

6 samples 1029 Miscellaneous -.99 Miscellaneous tests Measles IgG Diasorin Liaison XL Parvovirus B19 IgG Diasorin Liaison XL Parvovirus B19 IgM Diasorin Liaison XL Platelia Myco Serum pneumonia IgM ELISA rhtlv-i/ii Detection of antimyco pneumonia IgM in human serum by enzyme immunoassay. Architect i4000 Rubella IgG Architect i4000 Diasorin Liaison XL Rubella IgM Architect i4000 Syphilis TP Architect i4000 Toxo IgM Architect i4000 ToxoIgG Architect i4000 VZV IgG Diasorin Liaison XL RPR Reditest Syphilis INAB Registration No. 326MT Page 6 of 6 Edition 1, 12/10/2017