RAPID DIAGNOSTIC TEST (RDT)

We offer a full line of RDT lateral flow immunoassay tests that can be used in a Point-of-Care (POC) testing environment.

With reliable results in just minutes,  RDTs are used millions of times per year to help make difficult diagnoses when time counts.

POINT-OF-CARE (POC) TESTING

When laboratory resources are in short supply or the turnaround time of lab-based tests is just too long, POC tests really make a difference. Within minutes a diagnosis can be confirmed, with a high degree of confidence, and the appropriate treatment provided.

Count on POC testing to help you make decisions.

QUALITY – ISO 13485 & MDSAP

ISO 13485:2016 specifies the requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Medical Device Single Audit Program (MDSAP) is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements.

DiseaseSpecimenSensitivity
COVID-19 (SARS-CoV-2) IgM/IgG Antibody TestSerum/Plasma & Whole Blood>93% IgM & >98% IgG
Hepatitis B Virus surface AntigenSerum/Plasma1 ng/mL
Hepatitis B Virus surface AntigenSerum/Plasma1 ng/mL
Hepatitis B Virus surface AntibodySerum/Plasma20 mIU/mL
Hepatitis B Virus surface AntibodySerum/Plasma20 mIU/mL
Hepatitis B Virus e AntigenSerum/Plasma>98%
Hepatitis B Virus e AntigenSerum/Plasma>98%
Hepatitis B Virus e AntibodySerum/Plasma>96%
Hepatitis B Virus e AntibodySerum/Plasma>96%
Hepatitis B Virus core AntibodySerum/Plasma>96%
Hepatitis B Virus core AntibodySerum/Plasma>96%
Hepatitis C Virus AntibodySerum/Plasma>99%
Hepatitis C Virus AntibodySerum/Plasma>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodySerum/Plasma>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodySerum/Plasma>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodyWhole Blood>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodyWhole Blood>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodySerum/Plasma>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodySerum/Plasma>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodyWhole Blood>99%
Human Immunodeficiency Virus (HIV) 1/2 AntibodyWhole Blood>99%
HBsAg, HCV, HIV comboSerum/Plasma
Treponema pallidum AntibodySerum/Plasma>99%
Treponema pallidum AntibodySerum/Plasma>99%
Neisseria GonorrhoeaeVaginal/Urethra Swab105 cfu/mL
Neisseria GonorrhoeaeVaginal/Urethra Swab105 cfu/mL
Helicobacter Pylori AntibodySerum/Plasma
Helicobacter Pylori AntibodySerum/Plasma
Helicobacter Pylori AntigenFecal Extract
Helicobacter Pylori AntigenFecal Extract
Malaria (Pf)Whole Blood50 parasites/mL
Malaria (Pf/Pv)Whole Blood50 parasites/mL
Malaria (Pf/Pan)Whole Blood50 parasites/mL
Vibrio Cholerae O139Other*104 cfu/mL
Vibrio Cholerae O139Other*104 cfu/mL
Vibrio Cholerae O1 OgawaOther*104 cfu/mL
Vibrio Cholerae O1 OgawaOther*104 cfu/mL
Vibrio Cholerae O1 InabaOther*104 cfu/mL
Vibrio Cholerae O1 InabaOther*104 cfu/mL
Vibrio Cholerae O1Other*104 cfu/mL
Vibrio Cholerae O1Other*104 cfu/mL
VCO 139, VCO 1-O, & VCO 1-IOther*104 cfu/mL
VCO 139, VCO 1-O, & VCO 1-IOther*104 cfu/mL
F1 Antigen of Y. pestis PlagueOther*104 cfu/mL or 5 ng/mL
F1 Antigen of Y. pestis PlagueOther*105 cfu/mL or 5 ng/mL
TuberculosisSerum/Plasma
TuberculosisSerum/Plasma
Dengue Virus IgG/IgM AntibodySerum/Plasma
Dengue Virus IgG/IgM AntibodySerum/Plasma
RotavirusFecal Extract1 x 106 viral particles/mL
RotavirusFecal Extract1 x 106 viral particles/mL
AdenovirusFecal Extract1 x 106 viral particles/mL
AdenovirusFecal Extract1 x 106 viral particles/mL
Group A StreptococcusThroat Swab
Chlamydia trachomatisVaginal/Urethra Swab