Meningitis & Encephalitis
Molecular Testing

The stakes are high for accurate and timely laboratory testing methods

Don’t compromise your patient outcomes when viral ME is suspected. Use the Simplexa Direct kits for effective diagnosis of HSV 1 & 2 and VZV using CSF samples.

Simplexa Kits
 

Meningitis & encephalitis (ME) are some of the most terrifying and life-altering diseases in medicine. As a result, the stakes are high for accurate and timely laboratory testing that can be used for proper diagnosis and treatment of the underlying cause.

Although there are clear advantages to syndromic based panel testing, including the quick identification of a wide variety of CNS infectious pathologies, studies are showing that many targets included in the panel fail to reveal the etiology of the disease.1,2 Several studies have also reported both false-positive and false-negative results that lead to costly and ineffective treatments.2,3 With so much at stake, it is crucial for laboratories to use tests that fit hospital algorithms, are fast, and provide accurate results.

More data does not mean better data. Don’t compromise your patient outcomes when viral ME is suspected. Use the Simplexa Direct kits for effective diagnosis of HSV 1 & 2 and VZV using CSF samples.

1. Paxton, A. (2019). ME multiplex panel: debating the tradeoffs. College of American Pathologists. Retrieved from https://www.captodayonline.com/me-multiplex-panel-debating-the-tradeoffs/
2. Bard, J.D. & Alby, K. (2018). Point-counterpoint: Meningitis/encephalitis syndromic testing in the clinical laboratory. J Clin Microb. 56 (4), 1-10.
3. Cuomo, L., Trivedi, P., Cardillo, M.R., Gagliardi, F.M., Vecchione, A., Caruso, R., Calogero, A., Frati, L., Faggioni, A., & Ragona, G. (2001). Human herpesvirus 6 infection in neoplastic and normal brain tissue. J Med Virol. 63, 45-51.

Simplexa HSV 1 & 2 Direct and Simplexa VZV Direct

The right tests at the right time

When viral ME is suspected, use the Simplexa™ HSV 1 & 2 Direct and Simplexa™ VZV Direct kits. These assays are the first and only FDA cleared standalone tests for HSV 1/2 and VZV from CSF samples.

Accuracy and precision matter

The Simplexa HSV 1 & 2 Direct assay demonstrated 100% agreement with CSF from HSV molecular positive patients and the Simplexa VZV Direct assay demonstrated over 99% clinical agreement for both prospective and contrived CSF samples. This means you get accurate answers without complicated interpretation. Clinical studies of the Simplexa HSV 1 & 2 Direct assay have also been performed on all age groups, from birth to over 60 years old, so you can be confident in your results.

Tests that fit into your workflow

Each assay only requires 50 µl of CSF, so you have more sample for critical testing needs. Our LIAISON MDX® provides the ability to run each assay separately or at the same time on the same disc so that you have ultimate control of your workflow and testing algorithm. Cutaneous and mucocutaneous swab specimens are also cleared for the Simplexa HSV 1 & 2 Direct Kit for easy consolidation of your HSV testing.

Time is critical, don’t waste it

Enable STAT testing with true sample-to-answer, CLIA moderate complexity assays that provide results in only an hour.

Clinical Agreement Studies

In a thorough clinical study, our Simplexa HSV 1 & 2 Direct assay demonstrated 100% agreement with CSF from HSV molecular positive patients. The Simplexa VZV Direct assay demonstrated over 99% clinical agreement against PCR/bi-directional sequencing for both prospective and contrived CSF samples.

Simplexa HSV 1 & 2 Direct Clinical Agreement Studies
HSV CSF Clinical AgreementHSV swab Clinical Agreement
 

Simplexa VZV Direct Clinical Agreement Study
VZV CSF Clinical Agreement

Educational Webinars & Videos featuring Simplexa technology

Other Products

Enterovirus Primer Pair*

For amplification and detection of the 5′ non-coding region of the enterovirus genome with a FAM labeled forward primer.

HHV-6 (Human Herpesvirus 6) Primer Pair*

For amplification and detection of the P100 gene with a FAM labeled forward primer.

Parechovirus Primer Pair*

For amplification and detection of the 5′ untranslated region of the gene with a CFR610 labeled forward primer.

CMV Primer Pair*

For amplification and detection of the CMV UL83 gene with a FAM labeled forward primer.

*Analyte specific reagent. Analytical and performance claims have not been established. Not FDA cleared or approved for use on the LIAISON MDX®.

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