vircoTYPE^® HIV-1 Report

The calculated fold-change in wild type IC50 using the VirtualPhenotype™-LM approach

Clinical or Biological Cut-Off values for the interpretation of Fold Change results.

Clinical Cut-Offs (CCO) are derived from clinical observations in treated patients; CCO1 is the baseline FC value at which a 20% loss of virologic response of a fully susceptible Wild Type virus is expected; CCO2 is the baseline Fold Change value at which an 80% loss of virologic response of a fully susceptible Wild Type virus is expected.

A Biological Cut-Off (BCO) is given if CCOs are not available; the BCO is an indication of the natural variation of susceptibility of Wild Type viruses in an in-vitro lab assay.

Resistance analysis based on the magnitude of the calculated Fold Change versus the BCO or CCO.

Reviewed by an Expert Panel, these notes provide additional clinical knowledge to complete the understanding of the resistance analysis.

NRTI/NtRTI resistance-associated mutations reported on public lists (ANRS, Stanford, IAS-USA) or by drug development sponsors that are identified in the reverse transcriptase gene of the sample virus.

NNRTI resistance-associated mutations reported on public lists (ANRS, Stanford, IAS-USA) or by drug development sponsors that are identified in the reverse transcriptase gene of the sample virus.

PI resistance-associated mutations reported on public lists (ANRS, Stanford, IAS-USA) or by drug development sponsors that are identified in the protease gene of the sample virus.

Amino acids of the PR and RT gene that were included in the analysis.

Virus subtype determined by comparing the sequence of the sample virus' pol region with subtype-specific reference sequences from the Los Alamos National Laboratory database.

Drug names (generic and acronyms).

Clinical or Biological Cut-Off values for the interpretation of Fold Change results. Clinical Cut-Offs (CCO) are derived from clinical observations in treated patients; CCO1 is the baseline FC value at which a 20% loss of virologic response of a fully susceptible Wild Type virus is expected; CCO2 is the baseline Fold Change value at which an 80% loss of virologic response of a fully susceptible Wild Type virus is expected A Biological Cut-Off (BCO) is given if CCOs are not available; the BCO is an indication of the natural variation of susceptibility of Wild Type viruses in an in-vitro lab assay.

Calculated Fold Change (FC) in IC50 ; the numbers between brackets are the 95% confidence intervals around the calculated FC.

Graphical Representation of the resistance Continuum: each colored gradient bar represents the drug specific dynamic range of resistance values (ranging from the FC of a Wild Type virus to the 97.5th percentile of calculated FC values) CCO1 is indicated by a black vertical bar; CCO2 is indicated by a white vertical bar; the virus sample FC is indicated by a square For drugs which do not have Clinical Cut-Off values, the Biological Cut-Off (BCO) is indicated by a vertical dashed line.

A complete list of all amino acid differences from the reference Wild Type virus (HXB2) found in the patient sample.

Reviewed by an Expert Panel, these notes provide additional clinical knowledge to complete the understanding of the resistance analysis.

Detailed definitions for Fold Change and Cut-Off values, method description and clinical notes.

Includes a listing of disclaimers, setting the correct context in which to interpret the result provided.

Includes a print out of the exact sequence that was submitted by the referring laboratory for verification.