Research & Studies

At bioMONTR Labs, we believe in nurturing and re-investing in the scientific community.  As a key opinion leader laboratory, we take the opportunity to publish and present the exciting results from many of our assay development efforts.  Summaries are provided below for a few of our recent publications/presentations. Contact us if you are interested in learning more.

Hepatitis B pregenomic RNA: Performance of an Automated Real-Time Quantitative Assay
(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.
Validation of eMAG™ for HIV-1 Low Viremia Testing
(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.
Full Automation and Flexibility for Extraction of Free Circulating Nucleic Acids: Proof of Concept for eMAG™
(Presented at 2017 CVS in Savannah, GA) Summary: This study evaluated the use of eMAG for fully automated extraction of free circulating nucleic acids.
Prevelence and Correlates of Persistent HIV-1 RNA in Cerebrospinal Fluid During Antiretroviral Therapy
(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.
Workflow Optimization of the ViroSeq™ Human Immunodeficiency Virus-1 (HIV-1) Genotyping System
(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.
Proof of Concept: Novel Plasma Separation Cards for HCV/HIV Quantification
(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.
Detection of Inflammatory Biomarkers in Urine using a Dried, Shelf Stable Transport Device, ViveST®
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.
Novel Plasma Separation Cards for Collection in Resource-Limited Settings
(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.
Room Temperature Stable, Dry-Transport Technology for Molecular Diagnostic Controls
(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.
Proof of Concept: Plasma Separation Cards for Collection in Resource-Limited Settings
(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.
Ambient Temperature Shipping and Storage for Molecular Infectious Disease Testing: ViveST®
(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.
ING116070: A Study in Pharmacokinetics and Antiviral Activity of Dolutegravir in Cerebrospinal Fluid in HIV-1-infected, ART-Naive Subjects
(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.
Validation of Real-Time PCR Assay for HLA-B*5701 Detection: A Novel and Rapid Pharmacogenomic Test Predicting Abacavir Hypersensitivity Reaction
(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.
Detection of Low Level HCV RNA in Room Temperature Stored Samples using ViveST™, a Transformational Storage and Transport Device
(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.
ViveST™ for HBV Testing: A Transformation Ambient Storage and Transportation Device
(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.
ViveST™: A Revolutionary Ambient Temperature Storage and Transportation Device for Utilization in Infectious Disease Testing
(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.
Validation of ViroSeq HIV-1 Genotyping System v2.0 Using Automated Extraction: EasyMag®
(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.
A Novel Ambient Storage and Transport Device for Utilization in Infectious Disease Testing: ViveST™
(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.
A Novel, 2nd Generation Device for Ambient Storage and Transportation for Downstream Infectious Disease Testing: ViveST™
(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.
Virological Efficacy in Cerebrospinal Fluid and Neurocognitive Status in Patients with Long-Term Monotherapy Based on Lopinavir/Ritonavir: An Exploratory Study
(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.
A Novel Ambient Storage and Transport Device for Utilization in Infectious Disease Testing: ViveST™
(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.
Automation of the ViroSeq HIV-1 Genotyping Assay Using the Abbott m2000sp and NanoDrop 2000
(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.
Evaluation of ViveST for HCV Testing Using the COBSA TaqMan HCV Test v2.0
(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.
Real-Time Stability of Plasma Using ViveST™, a Revolutionary Ambient Temperature Storage and Transportation Device
(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.
Low-Level HIV RNA Declines Over Time in CSF but not in Plasma
(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.
Detection of HCV RNA in Cerebrospinal Fluid (CSF) Using the Abbott RealTime HCV Assay
(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.
Case Study: Driving Specialized Testing Through Assay Development
(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.
Novel Sample Storage and Transport by ViveST™ for Downstream HCV Viral Load and Genotypic Testing
(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.
Measurement of HCV Viral Load and Viral Genotype from Dried Blood Spots (DBS) and a Dried Ambient Transport Matrix (ViveST) Using the Abbott m2000 System
(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.
Evaluation of ViveST™ for HIV-1/HCV Testing Using Abbott's RealTime Assays
(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.
New HIV-1 SuperLow Assay For Viral Load Monitoring
(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.
Utility of HIV-1 EQ SuperLow Viral load Testing in HIV-associated Cognitive Impairment
(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.
HIV-1 SuperLow Viral Load as a Monitoring Tool for Antiretroviral Drug Penetration
(Presented at the 2009 Mdx Conference)  Summary:  Review of bioMONTR’s HIV-1 SuperLow Assay as a monitoring tool for antiretroviral drug penetration.