HIV 

ERBA Molecular has been developing a robust, low-cost and easy to use assay for HIV.  Molecular assays can deliver not only better sensitivity for HIV detection (essential for early infant diagnosis and pre-seroconversion diagnosis) but can deliver quantitative results for monitoring of therapeutic regimes.  There is a pressing need for such HIV tests to be applied in numerous non-centralised settings including:

  • Near-patient testing in general (in all geographies)
  • Testing in low-resource settings
  • Screening at strategic risk-points

ERBA Molecular has been able demonstrate that RNA-based assays could be performed just as easily as DNA based assays using ERBA Molecular technologies and therefore demonstrating the breadth of applications of the technology.  Many RNA-based assays are multi-step, require samples to be incubated at different temperatures, require extensive sample preparation and also, may be not be in a format to to be distributed outside of the cold chain. 

The HIV Product portfolio

ERBA Molecular has developed an HIV assay portfolio to exemplify the application of our technologies to this challenging field. This novel approach includes the RapidMag extraction technology, STEM primers, ERBA Molecular’s Novel Isothermal Amplification and the BART reporter system.

Qualitative assay

Viral Load

  • Screening assay
  • Early infant diagnosis (EID)
  • Standard Quantification
  • Novel quantitation

Qualitative assays

BART - (STEM) Molecular Detection System

HIV 1 Screening assay 

Molecular assay for the screening for HIV using STEM-LAMP-BART amplification using the rapid magnetic bead sample preparation (RapidMag) ERBA Molecular’s HIV screening assay is a sample preparation system and in vitro diagnostic test combined, for the direct detection of HIV1 from whole blood or plasma samples of patients suspected of having HIV.

Applications include ‘Early Infant Diagnosis’ (EID) or for early pre-seroconversion testing for newly acquired infections. This qualitative approach is applicable to a screening assay as it has very simple workflow and would be suited to use in a wide range of decentralized testing environments including physician office labs, STD clinics, blood collection sites and resource-poor settings.

Heat Elution steps

Sample input includes:

  • Whole Blood, 
  • Plasma, 
  • Bloodspots 

Making this suitable for a screening assay or for EID 

 

Viral Load

ERBA Molecular has developed a dual approach to viral load testing. The first 

  1. Standard Quantification - BART Molecular Detection System HIV 1 Viral Load Monitoring
  2. Novel Quantitation (Digital BART - Next Generation Quantification)

 

BART - (STEM) Molecular Detection System

HIV 1 Viral Load Monitoring 

ERBA Molecular’s HIV load monitoring is a sample preparation system and in vitro diagnostic test combined, for the direct detection and monitoring of HIV1 levels

The simple workflow of the Manual version of the assay is a three step process:  extract plasma using the RapidMag technology, add extract to amplification reagents, transfer to reader.  The reader will give an indication of how rapidly amplification occurs which is indicative of the level of HIV copies

ERBA Molecular’s HIV monitoring test is able to detect subtypes A, B, C, D, F, G, H, J and also recombinants AE, AG; further they also detect O group HIV strains. The primer sets has demonstrated its ability to provide broad inclusivity enabling the assay to be used in multiple geographies.

   

Digital BART (Next Generation Quantification)

Next Generation Quantification HIV 1 Viral Load Monitoring 

ERBA Molecular is working on enabling technologies that could allow more precise HIV load measurements to be made using the smaller sample volumes likely to be available at point of care. ERBA Molecular has also been applying its developments in digital amplification to improving HIV quantification.  In particular, the Company has a research program aimed at enabling smaller sample volumes to be used to deliver the required quantification metrics clinicians require.  

As with ERBA Molecular’s HIV monitoring test the Digital BART system is able to detect subtypes A, B, C, D, F, G, H, J and also recombinants AE, AG; further they also detect O group HIV strains. The primer sets has demonstrated its ability to provide broad inclusivity enabling the assay to be used in multiple geographies.   

 

Sample Preparation

The ease of sample preparation and processing is the key to the success of any assay system, and ERBA Molecular’s pursuit of simplicity and robustness has led to the development a number of novel and proprietary approaches, including RapidMag.

Viral extraction kit for whole blood or plasma

ERBA Molecular’s novel manual three-step viral extraction technology allows nucleic acid to be extracted from whole blood or plasma in 20 minutes.
The processed sample can then be added directly to freeze-dried amplification reagents.

 

RapidMag 450px

Other Low Resource Clinical Tests

ERBA Molecular has been involved in the development of a high through put screening assay for malaria. This and other potential low resource diagnostics such as Sleeping sickness (HAT), Chagas and this and other neglected diseases are well suited to the simplicity and robustness associated with ERBA Molecular’s technology, from sample prep through to result.

Potential Menu for Low resource:

  • HIV Viral Load
  • HIV (Early Infant Diagnosis)
  • Malaria
  • Chagas
  • Sleeping sickness (Human African Trypanosomiasis)
  • Leptosporsis
  • Tuberculosis
  • Leishmaniasis 

If you are interested in discussing commercial development opportunities for this application or technology please [click here]