Serology

Molecular Infectious Diseases – Hepatitis C RNA (Qualitative/ Quantitative)

Clinical material provided (Liquid Plasma – 1.2 mL) to assess the qualitative and quantitative detection of Hepatitis C RNA

Frequency / Number of samples

2 surveys / 6 samples per survey

Tests

HCV Qualitative RNA, HCV Quantitative RNA

Molecular Infectious Diseases – HIV-1 RNA (Quantitative)

Clinical material provided (Liquid Plasma – 1.2 mL) to assess the quantitative detection of HIV RNA

Frequency / Number of samples

2 surveys / 6 samples per survey

Tests

HIV-1 RNA Quantitative

Molecular Infectious Diseases – Human Papillomavirus DNA

Clinical material provided (Liquid PreservCyt® Solution – 4.0 mL hc2/Cervista, 2.0 mL other) to assess the detection and typing of HPV DNA using molecular assays

Frequency / Number of samples

4 surveys / 3 samples per survey

Tests

HPV DNA Hybrid Capture Low Risk Method, HPV DNA Hybrid Capture High Risk Method, HPV DNA Molecular Methods, HPV DNA Interpretation

Molecular Infectious Diseases – Influenza

Simulated clinical material provided (Liquid Inactivated viral culture lysate – 0.5 mL) to assess the detection and typing of Influenza using molecular assays

Frequency / Number of samples

3 surveys / 6 samples per survey

Tests

Influenza A Matrix, Influenza A H1, Influenza A H1 (pandemic), Influenza A H3, Influenza A H5, Influenza A H7, Influenza A N1 (avian), Influenza A N1 (pandemic), Influenza A NP (H1N1), Influenza B, Final Interpretation

Molecular Infectious Diseases – Respiratory Pathogens

Simulated clinical material provided (Liquid Inactivated culture lysate – 0.5 mL) to assess the detection and identication of Respiratory Pathogens using molecular assays

Frequency / Number of samples

3 surveys / 6 samples per survey

Tests

Repiratory Pathogens Multiplex Assays, Adenovirus, Bordetella pertussis, Chlamydia, Coronavirus, Coxsackievirus, Enterovirus, Haemophilus, human Metapneumovirus, Influenza A/B, Legionella, Mycoplasma pneumoniae, Parainfluenza (1-4), Pneumocystis, Respiratory Syncytial Virus, Rhinovirus, Final Interpretation

Molecular Infectious Diseases – Vaccine Preventable

Simulated clinical material provided (Liquid Inactivated culture lysate – 0.5 mL) to assess the detection and identication of Vaccine Preventable Pathogens using molecular assays

Frequency / Number of samples

2 surveys / 6 samples per survey

Tests

Vaccine Preventable Pathogens, Bordetella pertussis,Influenza A/B, Measles, Mumps, Rubella, Varicella zoster virus

Parasite & Spirochaete – Cryptococcal Antigen

Clinical or culture material provided (Liquid Serum or culture supernatant – 0.5 mL) to assess the detection of Cryptococcal Antigen

Frequency / Number of samples

2 surveys / 2 samples per survey

Tests

Cryptococcus Antigen Detection, Cryptococcus Antigen Detection Supplementary Detection, Cryptococcus Interpretation

Parasite & Spirochaete – Entamoeba serology

Clinical material provided (Liquid Serum / Plasma – 0.5 mL) to assess the detection of Entamoeba using serological markers

Frequency / Number of samples

2 surveys / 2 samples per survey

Tests

Entamoeba IHA, Entamoeba IFA, Entamoeba EIA, Entamoeba CIEP, Entamoeba Interpretation

Parasite & Spirochaete – Hydatid serology

Clinical material provided (Liquid Serum / Plasma – 0.25 mL) to assess the detection of Hydatid using serological markers

Frequency / Number of samples

2 surveys / 2 samples per survey

Tests

Hydatid Haemagglutination, Hydatid CFT, Hydatid EIA, Hydatid CIEP, Hydatid Western Blot, Hydatid ICT, Hydatid Interpretation

Parasite & Spirochaete – Leptospiral serology

Clinical material provided (Liquid Serum – 0.5 mL) to assess the detection of Leptospirosis using serological markers

Frequency / Number of samples

2 surveys / 2 samples per survey

Tests

Leptospirosis IgM, Leptospirosis IgG, Leptospirosis Macroscopic Agglutination, Leptospirosis Microscopic Agglutination, Leptospirosis Total Antibody, Leptospirosis Interpretation

Parasite & Spirochaete – Lyme Disease serology

Clinical material provided (Liquid Serum / Plasma – 0.5 mL) to assess the detection of Lyme Disease using serological markers

Frequency / Number of samples

2 surveys / 2 samples per survey

Tests

Lyme Disease IgG, Lyme Disease IgM, Lyme Disease Total Antibody, Lyme Disease IgG Confirmatory, Lyme Disease IgM Confirmatory, Lyme Disease Interpretation

Parasite & Spirochaete – Schistosomiasis serology

Clinical material provided (Liquid Serum / Plasma – 0.25 mL) to assess the detection of Schistosomiasis using serological markers

Frequency / Number of samples

2 surveys / 2 samples per survey

Tests

Schistosomiasis IgG, Schistosomiasis IgM, Schistosomiasis Total Antibody, Schistosomiasis Confirmatory, Schistosomiasis Interpretation