Viral Meningitis & Encephalitis
Early diagnosis of meningitis and encephalitis saves lives.
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Background
Meningitis and encephalitis are inflammatory conditions of the central nervous system (CNS) that can lead to high rates of mortality and disability worldwide.
Meningitis is the inflammation of the meninges, the membranes that surround the brain and spinal cord.
Encephalitis is the inflammation of the brain itself.
Meningitis and encephalitis can occur as a result of certain viral, bacterial, fungal, and parasitic infections.
Herpes simplex virus types 1 and 2 are common causes of viral meningitis and encephalitis. While herpes simplex meningitis is a self-limiting condition in patients with normal immunity1, herpes simplex encephalitis (HSE) is a life-threatening disease and it requires prompt treatment with intravenous antivirals.
Anyone at any age can get HSE. Although HSE is rare, mortality rate can reach 70% in the absence of therapy and only a minority of individuals return to normal function2. Intravenous acyclovir has shown to reduce mortality to 10-20%3. A rapid diagnosis is then critical to successful patient outcome.
1. Logan SAE, MacMahon E. Viral meningitis. BMJ. 2008;336(7634):36-40. doi:10.1136/bmj.39409.673657.AE
2. Tyler KL. Herpes simplex virus infections of the central nervous system: encephalitis and meningitis, including Mollaret’s. Herpes. 2004;11 Suppl 2:57A-64A.
3. Whitley RJ. Herpes Simplex Virus Infections of the Central Nervous System. Continuum (Minneap Minn). 2015;21(6 Neuroinfectious Disease):1704-1713. doi:10.1212/CON.0000000000000243
Annual impact of Meningitis in the United States
>
0
Meningitis-related hospitalizations
0
%
0.4 to 11.4% in-hospital mortality rate
$
0
b
$1.2 billion
Healthcare cost
Annual impact of Encephalitis in the United States
>
0
Encephalitis-related hospitalizations
0
%
5.8 to 17.1% in-hospital mortality rate
$
0
b
$2 billion
Healthcare cost
Ultra-fast.
Ultra-reliable.
Our proposed solution will deliver fast and accurate results in less than 30 minutes.
Although large meningitis and encephalitis molecular panels can identify a wide variety of CNS infection pathologies, studies are showing that they have moderate sensitivity for some targets and that additional testing is required for suspected HSE when results are negative4,5, resulting in a delay in diagnosis.
For professional use.
The miDiagnosticsTM HSV-1&2 CSF Test is intended to detect HSV-1 and HSV-2 targets with a high sensitivity, reducing the need for further confirmatory testing.
4. Vaugon E, Mircescu A, Caya C, et al. Diagnostic accuracy of rapid one-step PCR assays for detection of herpes simplex virus-1 and -2 in cerebrospinal fluid: a systematic review and meta-analysis. Clin Microbiol Infect. 2022;28(12):1547-1557. doi:10.1016/j.cmi.2022.06.004
5. Dien Bard J, Alby K. Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory. J Clin Microbiol. 2018;56(4):e00018-18. doi:10.1128/JCM.00018-18
How it works
How it works.
With sample preparation, amplification and detection, turnaround time is less than 30 minutes.
Sample
200 µl of Cerebrospinal fluid (CSF) is mixed with the PCR reagents.
PCR Card
A small volume of the sample (5µl) is placed on the disposable PCR Card containing the silicon chip.
Reader
The multiple use, portable reader performs the temperature cycling and optical detection, processes data and communicates the test result.
Key Benefits.
Unique silicon chip technology allowing for ultra-fast PCR
Closed reaction chamber limits risk of contamination
High clinical performance
“miDiagnostics has the potential to disrupt and transform the industry by making diagnostic information available to clinician and patient alike.”
“Its easy-to-use and cost-efficient test will revolutionize point-of-care testing by directly engaging with patients and enabling speedy intervention.”
“Proud to be leading a top team and together with our numerous partners to make a significant contribution to healthcare in general.”
“As a Non-Executive Director on miDiagnostics’ Board, I have been privileged to witness its continued development. I am very proud to see many years of hard work coming to fruition and providing value, facilitating the return to a normal way of life, with potential to move high quality testing closer to the patient.”
“This technology could aid the management of outbreaks in challenging settings, such as nursing homes and home care environments, allowing healthcare professionals to adjust their management decisions at the point of care. ”
