Meningococcal Disease (MD) caused by the bacteria Neisseria meningitidis is characterised by a rapid onset, difficult clinical diagnosis and high mortality (10-40%) and morbidity rates (20%). Up to 50% of cases are missed by GPs in the 24hrs before admission. Globally, there are approximately 500,000 cases per year causing an estimated 50,000 deaths and is most prevalent in young children (< 5 yrs) and the elderly.
Unmet Clinical Need:
- Accurate diagnosis
- Rapid results – Current culture methods can take up to 72 hrs
- Non-invasive samples
The Hg Solution:
- 100% Sensitivity and Specificity
- HG Meningococcus gives results in ≤ 60 minutes
- Testing from invasive and non-invasive samples
The HG Meningococcus test allows patients who test positive to be effectively and efficiently treated with target antibiotics.
It also allows MD to be rapidly ruled out with a negative result saving costs and time for the hospital and avoiding unnecessary antibiotics for the patients.
|Methodology:||Loop Mediated Isothermal Amplification (LAMP)|
|Target:||Neisseria meningitidis serogroups A, B, C, 29E, W135, X, Y, Z|
|Sample types:||Whole blood
Cerebrospinal fluid (CSF)
Nasopharyngeal swab Direct CSF
|Hands-on time:||≤ 10 minutes|
|Sample to result:||≤ 60 minutes|
|Product Name||# of Tests||Catalogue|
|HG Meningococcus Direct Swab||25||HGMENDS|
|HG Meningococcus Direct CSF||25||HGMENDCSF|
|HG Meningococcus Control||18||HGMENC|
*FDA submission is planned. Product is not available for sale in the US market.
2 Harrison L.H., C.L. Trotter, & M.E. Ramsay. 2009. Global epidemiology of meningococcal disease. Vaccine 27S: B51-B63
3 Scottish Intercollegiate Guidelines Network. Management of invasive meningococcal disease in children and young people. A national clinical guideline. Edinburgh: SIGN; 2008.
4 Bacterial meningitis and meningococcal septicaemia in children, NICE Clinical Guideline, June 2010
5 Bourke TW, McKenna JP, Coyle PV, Shields MD & Fairley DJ. 2015 Diagnostic accuracy of loop-mediated isothermal amplification as a near-patient test for meningococcal disease in children: an observational cohort study. Lancet Infectious Disease.