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HIV-1 - Human Immunodeficiency Virus, Type 1
- The following set of tests are for clinical and / or diagnostic applications and will be noted in the titles of the assays. If you have any special needs for a combination of the following assays, please contact us for special pricing.
Siemens TRUGENE HIV-1 Genotype Assay (FDA)
- Assay ID: GEN-HIV-0001 (00000001)
  
  Regions: Protease and Reverse Transcriptase
  
  FDA Approved. HIV-1 RNA specific nucleic acid sequencing from patient plasma or cell culture derived supernatant. Bi-directional sequencing of Protease (PR) and clinically relevant portions of the Reverse Transcriptase (RT) genes. Analysis includes tabular polymorphic fingerprint and TRUGENE™ Antiviral Resistance Report.
GeneTanker HIV-1 Select PR/RT Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0002 (00000008)
  
  Regions: Protease and Reverse Transcriptase
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant. The assay includes bi-directional nucleotide sequencing of clinically relevant mutations for: Protease (PR), and Reverse Transcriptase (RT amino acid 1-245). Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
  
  Assay is compatible with Virco®Type virtual phenotype reporting.
GeneTanker HIV-1 Select gp41 Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0003 (00000009)
  
  Regions: Subtyping and Fusion Inhibitor Resistance
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant. The assay includes bi-directional nucleotide sequencing of clinically relevant mutations in the gp41 envelope subunit. This test characterizes Fusion Class Inhibitor (FCI) resistance. The assay includes sequencing of the C2V3 portion of envelope used for sub-typing and possible tropic selection markers. Reporting in FASTA and/or ASCI text formats and MuTanker™ sequential alignments.
GeneTanker HIV-1 Complete Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0004 (00000010)
  
  Regions: gag, gag/pol cleavage, Protease, Reverse Transcriptase, C2V3 through gp41
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant. The assay includes bi-directional nucleotide sequencing of clinically relevant mutations for: gag/pol cleavage, Protease (PR), Reverse Transcriptase (RT amino acid 1-245) and the gp41 envelope subunit for Fusion Class Inhibitor (FCI) resistance detection. The assay includes sequencing of the C2V3 portion of envelope used for sub-typing and possible tropic selection markers. Reporting in FASTA and/or ASCI text formats and MuTanker™ sequential alignments.
GeneTanker HIV-1 Ultra-Select PR/RT Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0005 (00000011)
  
  Regions: Protease and Reverse Transcriptase
  
  Assay for use with ultra-low level viremia of <1,000 to 200 copies/mL
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant. The assay includes bi-directional nucleotide sequencing of clinically relevant mutations for: gag/pol cleavage, Protease (PR), Reverse Transcriptase (RT amino acid 1-245) and the gp41 envelope subunit for Fusion Class Inhibitor (FCI) resistance detection. The assay includes sequencing of the C2V3 portion of envelope used for sub-typing and possible tropic selection markers. Reporting in FASTA and/or ASCI text formats and MuTanker™ sequential alignments.
  
  Assay compatible with Virco®Type virtual phenotype reporting.
GeneTanker HIV-1 Ultra-Select gp41 Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0006 (00000013)
  
  Regions: Typing and Fusion Inhibitor Resistance
  
  Assay for use with ultra-low level viremia of <1,000 to 200 copies/mL
  
  Ultra-Sensitive homebrew test of low-level HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant. The assay includes bi-directional nucleotide sequencing of clinically relevant mutations in the gp41 envelope subunit. This test characterizes Fusion Class Inhibitor (FCI) resistance. The assay includes sequencing of the C2V3 portion of envelope used for sub-typing and possible tropic selection markers. Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
GeneTanker HIV-1 Ultra-Complete Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0007 (00000014)
  
  Regions: gag, gag/pol cleavage, Protease, Reverse Transcriptase, C2V3 through gp41
  
  Assay for use with ultra-low level viremia of <1,000 to 200 copies/mL
  
  Ultra-Sensitive homebrew test of HIV-1 specific sequences derived from patient plasma RNA or cell culture derived supernatant. The assay includes bi-directional nucleotide sequencing of clinically relevant mutations for: gag, gag/pol cleavage, Protease (PR), Reverse Transcriptase (RT amino acid 1-245) and the gp41 envelope subunit for Fusion Class Inhibitor (FCI) resistance detection. The assay includes sequencing of the C2V3 portion of envelope used for sub-typing and possible tropic selection markers. Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
GeneTanker HIV-1 Select gp160 Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0008 (00000014)
  
  Regions: gp160 envelope complete domain
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant equivalents. The assay includes bi-directional nucleotide sequencing of the entire envelope gp160 encoded protein. Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments as well as a phylogenetic bootstrap analysis and best fit report from the Research Think Tank, Inc database containing >350 sequences.
GeneTanker HIV-1 Select gag Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0009 (00000015)
  
  Regions: gag and gag/pol clevage
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant equivalents. The assay includes bi-directional nucleotide sequencing of gag and gag/pol cleavage sites. Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
GeneTanker Select RNase H Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0010 (00000016)
  
  Regions: RNase H Domain of Polymerase
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant equivalents. The assay includes bi-directional nucleotide sequencing of the RNase H domain of the polymerase gene. Reporting in FASTA and/or ASCI text formats and MuTanker™ sequential alignments.
GeneTanker Select Integrase Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0011 (00000017)
  
  Regions: Integrase Domain of Polymerase
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant equivalents. The assay includes bi-directional nucleotide sequencing of the Integrase domain of the polymerase gene. Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
GeneTanker Select gag/pol Sequencing Assay (RUO)
- Assay ID: GEN-HIV-0012 (00000018)
  
  Regions: gag/Protease/Reverse Transcriptase Domain of Polymerase
  
  Homebrew test of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant equivalents. The assay includes bi-directional nucleotide sequencing of gag/gag/pol cleavage sites/Protease (1-99 amino acids) and Reverse Transcriptase (1-240 amino acids). Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
GeneTanker Complete PROVIRAL DNA Sequencing Assay (RUO)
- Assay ID: GEN-HIV-PV01 (00000019)
  
  Regions: All
  
  Homebrew test of HIV-1 proviral DNA sequences derived from patient PBMC’s or DNA equivalents from cells in cell culture. The assay includes bi-directional nucleotide sequencing of clinically relevant mutations for: gag, gag/pol cleavage, Protease (PR), Reverse Transcriptase (RT amino acid 1-245) and the gp41 envelope subunit for Fusion Class Inhibitor (FCI) resistance detection. The assay includes sequencing of the C2V3 portion of envelope used for sub-typing and possible tropic selection markers.
Siemens VERSANT HIV-1 RNA 3.0 Assay Using bDNA Platform (FDA)
- Assay ID: VL-VER-0001 (00000020)
  
  Quantitative Assay for HIV-1 Viral load calculated as RNA copies/mL of blood using the automated Bayer ® Versant System 340 Analyzer. This is a signal-amplification nucleic acid probe test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA from human plasma.
Abbott RealTime HIV-1 Viral Load Assay (IVD) using the m2000 System (FDA)
- Assay ID: VL-HIV-ABRT (00000013)
  
  Quantitative IVD test for HIV-1 RNA viral load reported in copies/ml or International Units (IU/mL). This is a Real-Time PCR assay with homogenous Real-Time fluorescent detection for the quantitation of Human Immunodeficiency Virus Type 1 RNA in human plasma. The novel partially double-stranded fluorescent probe design allows detection of diverse Group M subtypes as well as group O and N isolates. Dynamic Range 40-10,000,000 copies/mL.
Virco Antivirogram HIV-1 Phenotyping by Recombinant PCR Methodology (RUO)
- Assay ID: PT-AVG-0001 (00000012)
  
  Regions: Protease Inhibitors and Reverse Transcriptase Inhibitors
  
  The Antivirogram® assay is a direct qualitative measure of the antiviral drug susceptibility of a recombinant virus reconstructed from patient plasma HIV-1 RNA. All of the clinically available protease inhibitors (PIs) and reverse transcriptase inhibitors (RTIs) are tested (n=15 drugs). Resultant data is used to predict the clinical response to these drugs. Results are provided in an easy to read format of resistance index, estimated contribution to response and clinical cut-off values.
  
  Experimental drug testing can be accomplished with additional service and set-up fees.
  
  Combination HIV-1 GENOTYPE and Antivirogram Packages available ("PhenoTanker-GT®")
PhenoTanker GT Combination Assay for Genotyping and Phenotyping (RUO)
- Assay ID: QVA-GP-0001 (00000021)
  
  Combination Assay for testing of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant. The assay includes GeneTanker® PR/RT Select (GEN-HIV-0002) bi-directional nucleotide sequencing of clinically relevant mutations for: Protease (PR), and Reverse Transcriptase (RT amino acid 1-245). Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
  
  The GeneTanker® PR/RT Select assay is compatible with Virco®Type virtual phenotype reporting algorithm.
  
  PLUS
  
  Virco Antivirogram® (AG-VIR-0001)
  
  Is a direct qualitative measure of the antiviral drug susceptibility of a recombinant virus reconstructed from patient plasma HIV-1 RNA. All of the clinically available protease inhibitors (PIs) and reverse transcriptase inhibitors (RTIs) are tested (n=15 drugs). Resultant data is used to predict the clinical response to these drugs. Results are provided in an easy to read format of resistance index, estimated contribution to response and clinical cut-off values.
  
  Experimental drug testing can be accomplished with additional service and set-up fees.
GenoTanker VT Combination Assay for Genotyping and Virtual Phenotyping (RUO)
- Assay ID: QVA-GP-0002 (00000022)
  
  Combination Assay for testing of HIV-1 RNA specific sequences derived from patient plasma or cell culture derived supernatant.
  
  The assay includes HIV-1 GeneTanker® PR/RT Select (GEN-HIV-0002) bi-directional nucleotide sequencing of clinically relevant mutations for: Protease (PR), and Reverse Transcriptase (RT amino acid 1-245). Reporting in FASTA and/or ASCI text formats and MuTanker™ columnar alignments.
  
  The GeneTanker PR/RT Select assay is compatible with Virco®Type virtual phenotype reporting algorithm.
  
  PLUS
  
  VircoTYPE® Virtual Phenotype Reporting Algorithm.
  
  Results are provided in an easy to read format of resistance index, estimated contribution to response and clinical cut-off values.
Roche AMPLICOR HIV-1 Monitor Version 1.5 Assay by PCR (FDA)
- Assay ID: VL-HIV-0001 (00000023)
  
  Quantitative Assay for HIV-1 Viral load calculated as RNA copies/mL of blood. Roche Amplicor HIV-1 Monitor™ PCR Test version 1.5. Subtype detection of Group M subtypes A-H. This is a nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. Dynamic Range of ≥400-750,000 RNA copies/mL.
Roche AMPLICOR HIV-1 Monitor Version 1.5 Ultra-Sensitive Assay by PCR (FDA)
- Assay ID: VL-HIV-0002 (00000024)
  
  Quantitative Assay for HIV-1 Viral load calculated as RNA copies/mL of blood. Roche Amplicor HIV-1 Monitor™ PCR Test version 1.5. Subtype detection of Group M subtypes A-H. This is a nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. Dynamic Range of 50-100,000 RNA copies/mL.
Roche COBAS AMPLICOR HIV-1 Monitor Version 1.5 Assay by PCR (FDA)
- Assay ID: VL-HIV-0003 (00000025)
  
  Quantitative Assay for HIV-1 Viral load calculated as RNA copies/mL of blood. Roche COBAS® Amplicor PCR Test. Subtype detection of Group M subtypes A-H. This is a nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma.
Roche COBAS AMPLICOR HIV-1 Monitor Version 1.5 Ultra-Sensitive Assay by PCR (FDA)
- Assay ID: VL-HIV-0004 (00000026)
  
  Quantitative Assay for HIV-1 Viral load calculated as RNA copies/mL of blood. Roche COBAS® Amplicor PCR Test. Subtype detection of Group M subtypes A-H. This is a nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. Dynamic Range of 50-100,000 RNA copies/mL.
Roche COBAS AmpliPrep / COBAS TaqMan HIV-1 (IVD) Assay (FDA)
- Assay ID: VL-HIV-0005 (00000027)
  
  Quantitative IVD test for HIV-1 RNA viral load reported in copies/ml or International Units (IU/ml). This is a Real-Time PCR assay for the quantitation of Group M subtypes of HIV Type 1 RNA. It employs a duel-labeled oligonucleotide probe for detection and quantitation of patient viral RNA and quantitation standard.
  
  Dynamic Range 48-10,000,000 copies/ml.
Siemens TRUGENE HIV-1 Genotyping Assay with
Roche AMPLICOR HIV-1 Monitor version 1.5 Viral Load Assay (FDA)
- HIV-1 Nucleic Acid Sequencing from patient plasma (RNA) or cell culture supernatant (RNA). Bidirectional sequencing of Protease and clinically relevant portions of the Reverse Transcriptase genes. Analysis includes tabular polymorphic fingerprint and TRUGENE Antiviral Resistance Report
  
  PLUS
  
  Quantitative Assay for HIV-1 Viral load calculated as RNA copies/mL of blood. Roche Amplicor HIV-1 Monitor™ PCR Test version 1.5. Subtype detection of Group M subtypes A-H. This is a nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus (HIV) RNA in human plasma.
HCV - Hepatitis C Virus
- The following set of tests are for clinical and / or diagnostic applications and will be noted in the titles of the assays. If you have any special needs for a combination of the following assays, please contact us for special pricing.
Siemens TRUGENE HCV 5'NC Genotype Assay (RUO)
- Assay ID: GEN-HCV-0001 (00000028)
  
  Regions: 5'NC
  
  TRUGENE Tower Sequencing Platform kit based test of HCV RNA specific sequences derived from Roche Amplicor HCV COBAS® RT-PCR amplicon products. Kit utilizes genotype of the 5’NC region for VIRAL TYPE specification.
  
  NOTE: Upon special request sample can be amplified from plasma or serum or “Replicon System” supernatant and sequenced direct. The assay includes bi-directional nucleotide sequencing of a portion of the 5'NC region. Analysis includes TRUGENE standardized reporting format that contains typing information and best-fit analysis.
  
  ***TaqMan products cannot be substituted with this test***
Siemens TRUGENE HCV NS5b Complete Genotype Assay (RUO)
- Assay ID: GEN-HCV-0002 (00000029)
  
  Regions: NS5b (RNA-dependent RNA polymerase)
  
  Homebrew test of HCV RNA specific sequences derived from patient plasma, serum or Replicon System supernatant. The assay includes bi-directional nucleotide sequencing of the complete or Select 5’ portion (partial) RNA-dependent RNA polymerase (NS5b) gene. The assay includes a validated typing module and standardized report. Reporting includes FASTA sequences and sequence alignment mapping (best fit) using RTT database.
Siemens TRUGENE HCV NS3/4a Complete Sequencing Assay (RUO)
- Assay ID: GEN-HCV-0003 (00000030)
  
  Regions: NS3/4a (Serine Protease)
  
  Homebrew test of HCV RNA specific sequences derived from patient plasma, serum or “Replicon System” supernatant. The assay includes bi-directional nucleotide sequencing of the complete Serine Protease (NS3/4a) gene. The assay includes a standardized report. Reporting includes FASTA sequences and sequence alignment mapping (best fit) using RTT database.
Siemens TRUGENE HCV Core/E1 Complete Typing Assay (RUO)
- Assay ID: GEN-HCV-0004 (00000031)
  
  Regions: Core/E1
  
  Homebrew test of HCV RNA specific sequences derived from patient plasma, serum or “Replicon System” supernatant. The assay includes bi-directional nucleotide sequencing of the Core and E1 regions. The assay includes a validated typing module. Reporting includes FASTA sequences and sequence alignment mapping (best-fit) using RTT database.
Siemens Inno-LiPA HCV (RNA) Typing 5'NC Assay (RUO)
- Assay ID: LP-HCV-0005 (00000032)
  
  Regions: 5'NC
  
  Reverse Hybridization Line Probe Assay (LiPA) Kit based test of HCV RNA specific sequences derived from Roche Amplicor HCV COBAS® RT-PCR amplicon products. Kit utilizes genotype of the 5’NC region for VIRAL TYPE specification.
  
  NOTE: Upon special request sample can be amplified from plasma or serum or “Replicon System” supernatant and assayed direct. Analysis generated using Auto LiPA instrumentation and reporting through Research Think Tank, Inc formatting.
  
  ***TaqMan products cannot be substituted with this test***
Roche COBAS AmpliPrep / COBAS TaqMan HCV Assay (IVD)
- Assay ID: VL-HCV-0002 (00000033)
  
  An in vitro nucleic acid amplification test for the quantitation of HCV RNA in human plasma or serum using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® 48 analyzer for automated amplification and detection.
Siemens Versant version 3.0 HCV Viral Load Assay with bDNA (FDA)
- Assay ID: VL-VER-0002 (00000034)
  
  Quantitative Assay for HCV Viral load calculated as RNA copies/mL or International Units (IU) or Log10 copies using the Automated Bayer Versant System 340 bDNA Analyzer. This is a signal-amplification nucleic acid probe test for the quantitation of Hepatitis C Virus (HCV) RNA in human serum or plasma.
HBV - Hepatitis B Virus
- The following set of tests are for clinical and / or diagnostic applications and will be noted in the titles of the assays. If you have any special needs for a combination of the following assays, please contact us for special pricing.
GeneTanker HBV Complete (RUO)
- Assay ID: GEN-HBV-0002 (00000035)
  
  Regions: All
  
  Homebrew test of HBV specific sequences derived from patient plasma or serum. Amplification is accomplished using high fidelity proofreading enzyme blends generating an amplicon approximately 2.95 kb in length. The assay includes bi-directional nucleotide sequencing of the entire dsDNA genome region. Analysis includes a standardized reporting format containing resistance- associated mutations (RAM) in pol/SA overlap as well as FASTA nucleotide sequences excluding the ssDNA region. Subtype analysis available upon request using a highly characterized database and best-fit analysis of the pol/SA overlapping region.
Roche COBAS TaqMan Assay for use with the High Pure System (FDA)
- Assay ID: VL-HBV-0002 (00000036)
  
  The COBAS® TaqMan® HBV Test For Use With The High Pure System is an in vitro nucleic acid amplification test for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) using the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. This is a partially automated Real Time PCR viral load test. The target is a highly conserved region of the pre-Core/Core part of the HBV genome and is found in all HBV genotypes A through G. This robust test covers common pre-Core mutations including HBeAg-negative viruses. The dynamic range of the test is 29 to 110 million IU/mL.
Inno-LiPA HBV Drug Resistance Assay (RUO)
- Assay ID: LP-HBV-0001 (00000037)
  
  Reverse Hybridization Line Probe Assay for detection of Drug Resistance Mutations in YMDD motif of the RT/pol gene. Analysis and Report generated using Auto LiPA instrumentation and reporting format.
Inno-LiPA HBV Genotyping Assay (RUO)
- Assay ID: LP-HBV-0002 (00000038)
  
  Reverse Hybridization Line Probe Assay for detection of Drug Resistance and Sub-typing using RT portion of the pol gene and overlapping Surface Antigen region. Analysis and Report generated using Auto LiPA instrumentation and reporting format.
Inno-LiPA HBV Pre-Core Assay (RUO)
- Assay ID: LP-HBV-0003 (00000039)
  
  Reverse Hybridization Line Probe Assay for detection of mutations or genotype of the pre-core region. Analysis and Report generated using Auto LiPA instrumentation and reporting format.