Carbapenem Resistance Quality Controls - both Molecular & Antigen
All tests for antibiotic resistance require controls. Here we introduce IVD molecular controls and IVD antigen detection controls for Carbapenemases
Carbapenem-resistant Enterobacteriaceae
The increased incidence of carbapenemase-producing Enterobacterales (CPE) has significant cost and operational implications for healthcare providers.
Unless action is taken and we learn from experiences elsewhere in the world, rapid spread of CPE will pose an ever-increasing threat to public health and medical treatment pathways in the UK. Ref: UKHSA publications gateway number GOV-10737
Microbiologics Controls for Molecular Diagnostics
Helix Elite™ Molecular Standards are FDA Class I exempt, unassayed, in vitro diagnostic external controls, and are intended for professional laboratory use only. Independent external controls provide accurate, reliable results, although results with diagnostic instruments may vary.
Our Helix Elite™ products are non–hazardous materials for safe handling and come in a test-ready format. Conveniently, they can be stored at ambient temperature.
Microbiologics Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (Inactivated Swab)
Based on Klebsiella NCTC strains with the following prperties;
- NCTC 13476 - IMP-type
- NCTC 13438 - KPC-3
- NCTC 13443 - NDM-1
- NCTC 13442 - OXA-48
- NCTC 13440 - VIM-1,
Each negative control swab consists of Escherichia coli derived from NCTC 11954
Coris BioConcept penta Control for Carbapenemase antigen tests
Coris BioConcept has developed a range of positive viral, bacterial and parasitic control products. These references are in liquid or freeze-dried form and contain a non-hazardous antigen preparation for use with an immunoassay.
These controls were initially developed for use with the matching Coris BioConcept products. However, we have found these Coris Control products to function well with antigen detection products from other manufacturers.
These products are IVD registered.
RESIST penta O.K.N.V.I control
This product consists of 5 freeze dried vials, each containing one of the big 5 carbapenemases: OXA48, KPC, NDM, VIM & IMP. Each vial contains reagent for a minimum of 4 tests.
Applications
- Verification of immunoasay instruments/systems
- Educational and R&D purposes
- Laboratory personnel training
PROTOCOL FOR USE OF FREEZE-DRIED CONTROLS:
1 To be rehydrated with 1 mL of distilled water.
2 Transfer 200 µL of positive control into a tube. Positive controls should be treated as patient samples.
3 Add 6 drops of the dilution buffer (provided in the diagnostic kit) to reach a dilution ratio of 1/2.
4 Stir thoroughly to homogenize the solution.
5 Use the mixture according to IVD test kit instructions.
