Cerebrospinal fluid CXCL10 is associated with the presence of low level CSF HIV during suppressive antiretroviral therapy

Low-Level HIV RNA in Cerebrospinal Fluid and Neurocognitive Performance: A Longitudinal Cohort Study

(Presented at the 2009 Mdx Conference)  Summary:  Review of bioMONTR’s HIV-1 SuperLow Assay as a monitoring tool for antiretroviral drug penetration.

(Presented at the 2010 III International Clinical Virology Symposium and Advances in Vaccines in Buenos Aires, Argentina) Summary:  This study assessed whether low levels of HIV in cerebrospinal fluid (CSF) were associated with inter-individual differences in ART regimens and neuropsychological (NP) performance using bioMONTR’s HIV-1 SuperLow assay.

(Presented at the 2011 Association for Molecular Pathology Annual Meeting in Grapevine, Texas)  Summary:  Performance review of bioMONTR’s HIV-1 SuperLow Assay for real-time HIV-1 quantitation.  The RESEARCH USE ONLY assay has a validated 95% hit rate of 15 c/mL and a reportable range of 2 to 10M c/mL.  The HIV-1 SuperLow Assay will be a valuable tool  for monitoring HIV-1 viral load and patient response in drug development and clinical trial programs.

(Presented at the 2012 Clinical Virology Symposium (CVS) in Daytona Beach, Florida)  Summary:  This study compared the performance of ViveST, a novel dried ambient transportation matrix, to frozen plasma for use with commercially available HCV and HIV-1 viral load and genotypic assays.

(Presented at the 2012 International Workshop on HIV and Hepatitis Virus: Drug Resistance and Curative Strategies (IHDRW) in Sitges, Spain) Summary:  This study evaluated the use of specimen types other than plasma for HCV diagnostic assays to eliminate logistical limitations and improve clinical management of patients on anti-viral therapy in resource-limited settings.

(Presented at the Next Generation Dx Summit, August 21-23, 2012)  Summary:  Review of performance data for ViveST, a novel sample storage and transport device, for use with the Abbott RealTime HCV Assay.

(Presented at the G2 Intelligence MDx Conference, September 13-14, 2012)  Summary:  Charting the development of a molecular diagnostic assay for an unmet clinical need.  Describe the potential benefits of collaborative relationships with pharma and external researchers in bringing up a novel test.

(Presented at 2012 HIV DART in San Diego, CA)  Summary:  This study assessed the Abbott RealTime HCV Assay for its ability to quantitate HCV RNA in CSF.

(Presented at 2013 CROI in Atlanta, GA) Summary:  This study assayed CSF and plasma samples from ART-treated individuals using an assay capable of quantitating HIV RNA to 2 cp/mL to determine the correlates of low-level HIV RNA with disease, treatment and neurocognitive characteristics.

(Presented at 2013 CVS in Daytona Beach, FL)   Summary:  This study evaluated the stability of infectious plasma samples stored on ViveST™, a novel dried ambient transportation matrix and analyzed with the Abbott RealTime HIV-1 and HCV viral load assays.

(Presented at 2013 CVS in Daytona Beach, FL)  Summary:  This study evaluated the performance of COBAS® TaqMan® HCV Test, v2.0 when using HCV infected samples stored and processed on ViveST™, a novel dried sample collection and transportation device.

(Presented at 2013 CVS in Daytona Beach FL)  Summary:  Describes the performance of the ViroSeq HIV-1 Assay when used with the Abbott m2000sp for automated nucleic acid extraction and Nanodrop 2000 spectrophotometer for amplicon quantitation.

(Presented at 2013 IHHDRW in Toronto, CA)  Summary:  This study evaluated a novel ambient storage and transport device in combination with the Abbott ViroSeq HIV-1 Genotyping v2.0 assay for sequencing Protease and RT Regions.

(Published in PLOS ONE, July 2013, Volume 8, Issue 7, e70201)  Summary:  A cross-sectional study to explore data on suppression of HIV replication in the CNS and on the subsequent risk of neurocognitive impairment using monotherapy with boosted protease inhibitors.

(Presented at the Next Generation Dx Summit, August 22, 2013)  Summary:  A summary of data evaluating the stability and reproducibility of infectious plasma specimens stored on ViveST and analyzed with RT-PCR and Sequencing Technologies.

(Presented at 2013 ID Week in San Francisco, CA)  Summary: This study evaluated ViveST, a transformational ambient storage and transport device for use with viral load and drug resistance assays.

(Presented at 2013 AMP in Phoenix, AZ)  Summary:  This study validated the performance of the ViroSeq HIV-1 Genotyping System v2.0 utilizing easyMag for automated extraction and NanoDrop for amplicon quantitation.

(Presented at 2013 AMP in Phoenix, AZ)  Summary:  These studies evaluate the use of ViveST, a novel dried ambient transportation matrix, for storage and transport of plasma samples used with downstream molecular based quantitative viral load assays.

(Presented at 2013 HEP DART on the Big Island, Hawaii)  Summary:  This study evaluated the performance of ViveST, a transformation dried sample storage and transportation device, for downstream HBV viral load testing using the Abbott RealTime HBV assay.

(Presented at 2014 CVS in Daytona Beach, FL) Summary:  This study evaluated the storage of low titer HCV plasma using ViveST, a transformational dried storage and transport device, in combination with the Abbott RealTime HCV assay.

(Presented at 2014 CVS in Daytona Beach, FL)  Summary:  A description of the analytical performance of a real-time PCR assay for the detection of the HLA-B*5701 allele.

(Clinical Infectious Diseases Advance Access publication published June 18, 2014)  Summary:  Median dolutegravir concentrations in cerebrospinal fluid were similar to unbound dolutegravir concentrations in plasma and in all subjects exceeded the in vitro 50% inhibitory concentration for wild-type viruses (0.2 ng/mL) by ≥ 66-fold, suggesting that dolutegravir achieves therapeutic concentrations in cerespinal fluid.  HIV-1 SuperLow Viral Load assay on CSF samples performed by bioMONTR Labs.

(Presented at 2014 AMP in Washington, D.C.)  Summary:  This study evaluated the stability of HIV-1 plasma samples shipped and stored on ViveST, a trasnformational dried ambient temperature storage and transportation device.

(Presented at 2014 HIV DART in Miami, FL)  Summary:  This study evaluated the functionality and performance of a novel prototype plasma separation card that collects capillary blood, separates cellular components by gravity and stores plasma at ambient temperature pending analysis.

(Presented at 2015 CVS in Daytona Beach, FL)  Summary:  In this study sets of molecular diagnostc controls were analyzed in their native frozen state and compared to controls stored on ViveST in a dried, thermostable format.

(Presented at 2015 AMP in Austin, TX)  Summary:  This study evaluated the functionality and performance of a novel prototype plasma separation card that collects capillary blood, separates cellular components by gravity and stores plasma at ambient temperature pending analysis.

Presented at 2015 ASN in San Diego, CA)  Summary:  This study described the detection of CXCL9/MIG and CXCL-10/IP-10 in urine spectrophotometrically, in combination with a novel collection device ViveST, eliminating the need for cold chain storage.

(Presented at 2015 HEP DART in Maui, HI)  Summary:  This study evaluated the performance of a novel prototype plasma separation card composed of a polysulfone separation membrane and absorbent collection pad allowing the separation of cellular components and collection/stabilization of plasma at ambient conditions.

(Hum Virol Retrovirol 2015, 2(7); 00071) Summary: The study evaluated workflow organization and automation improvements to the ViroSeq HIV-1 Genotyping System through the use of semi-automated extraction platforms, automated amplicon quantification, and high-throughput sequencing platforms.

(The Journal of Infectious Diseases 2017;215:105-13) Summary:  bioMONTR Labs’ proprietary HIV-1 SuperLow Assay was utilized to measure HIV-1 RNA levels in CSF and plasma from adults taking suppressive ART to assess if the association between HIV-1 RNA discordance and HAND may reflect compartmentalization.

(Presented at 2017 CVS in Savannah, GA) Summary: This study evaluated the use of eMAG for fully automated extraction of free circulating nucleic acids.

(Presented at 2017 CVS in Savannah, GA) Summary: A presentation of the validation for using the eMAG with bioMONTR Labs’ HIV-1 SuperLow assay, a RESEARCH USE ONLY for detection of single copy HIV-1 RNA.

(presented at 2019 CVS in Savannah, GA) Summary:  A presentation of the analytical performance of a new assay for the detection and quantitation of hepatitis B pregenomic RNA in CHB patients.