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Clinical and Preclinical Applications
Preclinical SIV & SHIV Programs

Non-Human Primate Study
Bioanalysis

Human HIV assay expertise, translated for demanding NHP models

If your research program depends on SIV or SHIV models to advance HIV cure or vaccine candidates, you need a bioanalytical partner whose assays were built for the unique demands of non-human primate (NHP) research. Accelevir Diagnostics, a CAP/CLIA-accredited bioanalytical CRO in Baltimore, Maryland, translates proven human HIV-1 assay expertise – including the IPDA®, cell-associated viral RNA quantification, and immune response monitoring – directly into validated workflows for non-human primates.
Overview

Over 100,000 primates are used annually in biomedical research worldwide, and rhesus macaque models remain the most physiologically relevant preclinical bridge between in vitro or ex vivo lab studies and human clinical trials for HIV therapeutics. Non-human primates share a high degree of genetic and anatomical homology with humans, making them indispensable for studying viral reservoir dynamics, vaccine immunogenicity, and latency reversal interventions that simpler organisms cannot replicate.

Accelevir Diagnostics, a CAP/CLIA-accredited bioanalytical CRO in Baltimore, Maryland, adapts proven human HIV-1 assay platforms to the strain-specific molecular and immunological requirements of SIV and SHIV animal model systems.
Integrated NHP Bioanalysis
Molecular virology · immunology · tissue processing · biobanking

More insight from every sample

Why Researchers Trust Accelevir

Why Researchers Trust
Accelevir for NHP Study Bioanalysis

CAP/CLIA-Certified, BSL-2+ Laboratory

CAP/CLIA-certified, BSL-2+ laboratory in Baltimore, MD – regulated facility with established quality systems for handling NHP-derived samples.

Continuous Digital PCR Expertise

Continuous digital PCR expertise from the original RainDance platforms through current-generation Bio-Rad QX systems – supporting methods with a dynamic range spanning approximately six orders of magnitude.

100+ Studies Supported

100+ clinical and translational studies supported with IPDA and related viral persistence assays.

Validated Workflows

Validated workflows with validation documentation structured for regulatory submission, including IND-enabling research projects.

Efficient Assay Design

Efficient assay design across molecular and immunology workflows maximize data output per sample, help to minimize the number of research animals or collection procedures required.
Why Choose Accelevir

Why Choose Accelevir for SIV/SHIV Model Bioanalysis

Accelevir’s differentiation in non-human primate research stems from directly adapting human HIV-1 assay platforms – already validated across large clinical cohorts – to the specific molecular and immunological requirements of SIV and SHIV animal model systems. This is not generic contract testing; it is science conducted by scientists who understand reservoir biology, proviral defect classification, and the nuances of translating preclinical NHP data toward human applications.

The same digital PCR frameworks validated for human HIV-1 IPDA, adapted for SIV and SHIV models.

01

SIV IPDA and SHIV IPDA Optimization

Primer and probe sets adapted for viral polymorphisms across strains (e.g., SIVmac251, SIVmac239, SHIV_SF162P3, SHIV_AD8, SHIV_CH505), with hypermutation exclusion and DNA Shearing Index correction to avoid the underestimation that plagues generic PCR approaches.

02

Ultra-Sensitive Detection of Low-Copy Viral Targets

Molecular assays designed to analyze millions of cell-equivalent genomic DNA per sample without inhibition, enabling detection of intact proviruses at frequencies as low as single copies per million cells in both blood and tissue samples.

03

Seamless Human-to-NHP Translation

The same digital PCR technologies and analytical frameworks validated for human HIV-1 IPDA are adapted for your SHIV model or SIV study, reducing development timelines.

04

Comprehensive Sample Processing and Biobanking

From PBMC isolation and tissue dissociation to long-term vapor-phase liquid nitrogen storage with full chain of custody, supporting longitudinal studies spanning months or years.
Our NHP Research Services

Molecular, Genomic, and Immunological Assays for SIV/SHIV Studies

Accelevir provides molecular, genomic, and immunological assays specifically adapted for SIV/SHIV studies in nonhuman primates. Each service is designed around the practical challenges researchers face: limited tissue availability, strain-specific viral diversity, the need to discriminate intact from defective proviruses, and the requirement for regulatory-ready data.

Duplex ddPCR distinguishes intact proviruses from defective forms.

01

SIV and SHIV IPDA

The Intact Proviral DNA Assay adapted for SIV and SHIV models uses duplex droplet digital PCR simultaneously targeting multiple regions of each proviral genome to distinguish intact proviruses from defective forms carrying large deletions or APOBEC-induced hypermutation. This high-throughput assay provides accurate and precise quantification of the latent reservoir, enabling viral persistence and cure researchers to track reservoir dynamics and identify effective therapeutic strategies to advance towards human trials. This assay is for research aimed at determining reservoir decay kinetics under ART, evaluating latency reversal agents, or measuring the impact of novel therapeutic interventions on intact proviral frequency.

CA-RNA readouts capture active viral expression alongside DNA-based measures.

02

SIV/SHIV Cell-Associated RNA Assays

Viral cell-associated RNA (CA-RNA) assays measure active viral transcription in NHP samples, providing a complementary readout to DNA-based reservoir assays. When researchers need to measure basal viral gene expression in ART-suppressed animals or determine whether a latency reversal agent is inducing viral expression, CA-RNA quantification from HIV-1 persistence assay workflows adapted for SIV/SHIV delivers that answer. When rodents or cell cultures fail to replicate the complexity of lentiviral latency and reactivation in people, NHPs serve as a predictive preclinical bridge to human trials. NHPs contribute to research on complex infectious diseases like HIV that cannot be accurately modeled in simpler animals, and SIV/SHIV CA-RNA assays are essential for distinguishing genuine biological signal from assay noise in these studies.

ELISpot, ICS, and multiplex readouts run with defined acceptance criteria.

03

Immune Response Monitoring for NHP Models

Evaluating vaccine immunogenicity, therapeutic efficacy, and immune correlates of protection in SIV/SHIV models requires immunological assays adapted for primate biology. NHPs are crucial for testing vaccines, biologics, and antiviral treatments due to pathogen interactions with human-like receptors, and robust immune monitoring is the backbone of any efficacy determination.

Processing and biobanking with full chain-of-custody documentation.

04

NHP Sample Processing and Biobanking

Reliable bioanalysis starts with rigorous sample processing. Accelevir provides end-to-end PBMC processing services and tissue handling for NHP studies, ensuring nucleic acid integrity and cell viability from collection through long-term storage.
Study Workflow

How Our NHP
Bioanalysis Works

From the moment your NHP samples arrive in Baltimore to final data delivery, Accelevir's workflow is built around traceability, sensitivity, and scientific rigor.

01
Every shipment is logged with sample-level annotation for full traceability.
01

Step 1

Step 1

Sample Receipt and Processing

Your lab ships frozen PBMCs, enriched cell subsets, extracted DNA/RNA, or fresh tissue samples to Accelevir’s BSL-2+ facility. Each shipment is logged into our tracking system with sample-level annotation (e.g., animal ID, study ID, tissue, timepoint, treatment group). Quality control checkpoints depend upon the sample type received. These include viable cell recovery and phenotype assessment for blood, tissue samples and/or viably thawed cryopreserved cells, as well as nucleic acid quantification, integrity analysis, and shearing evaluation. If additional processing is needed – cell subset isolation, nucleic acid extraction, cryopreservation, or aliquoting for multiple downstream assays – Accelevir handles it under documented procedures.
02
Validated primer/probe sets and optimized SOPs drive every assay run.
02

Step 2

Step 2

Assay Execution and Analysis

Molecular assays (SIV IPDA, SHIV IPDA, CA-RNA) proceed on digital PCR platforms with validated primer/probe sets. For immune monitoring, ELISpot plates, flow cytometry panels, and functional assays run with appropriate positive and negative controls, triplicate wells, and defined acceptance criteria. All assays are performed following optimized SOPs by highly skilled operators.
03
Comprehensive data packages formatted for publication or regulatory submission.
03

Step 3

Step 3

Data Delivery and Support

Researchers receive comprehensive data packages including analyzed results, quality metrics, and statistical summaries formatted for publication or regulatory submission. Assay qualification reports and method descriptions are available for IND-enabling programs. Accelevir scientists are available for technical consultation on data interpretation, assay optimization, and study design for subsequent phases.
Research Programs We Support

Bioanalysis Across the
Preclinical Continuum

Accelevir’s bioanalytical services support a broad range of NHP research projects in the HIV/SIV field. NHPs make up an estimated 0.5% of the animals used in U.S. biomedical research, yet they generate outsized scientific value for public health programs. Today’s NHP studies continue to drive translational medicine forward, including in the HIV remission and cure field. Responsible science demands that every NHP sample generates maximum data – a principle that guides Accelevir’s approach to assay multiplexing and sample conservation. USDA requires scientific justification for using non-human primates, and Accelevir’s analytical efficiency supports researchers in meeting that standard.

01

HIV Cure Research and Latency Reversal Studies

Quantifying intact proviral reservoir changes following therapeutic interventions using SIV IPDA or SHIV IPDA, with paired CA-RNA readouts to measure transcriptional reactivation.

02

Vaccine Development and Immunogenicity Testing

Comprehensive immune monitoring via ELISpot, ICS, proliferation, and cytotoxicity assays to evaluate T cell and antibody responses to SIV/SHIV antigens.

03

Therapeutic Efficacy Evaluation in SIV/SHIV Models

Longitudinal measurement of viral persistence, expression, and immune responses across treatment modalities, including broadly neutralizing antibodies, therapeutic vaccines, cell therapies, immune cell engagers, TACK molecules, and long-acting capsid inhibitor studies.

04

Longitudinal Viral Persistence Studies

Biobanking and serial sample analysis across months of ART suppression and analytical treatment interruption, tracking multiphasic reservoir decay and potential rebound.
FAQ

Frequently Asked Questions

One coordinated laboratory environment supports continuity across matrices, timepoints, and analytical teams.

What sample types and volumes do you accept for SIV/SHIV analysis?
Accelevir accepts a wide variety of NHP sample types, including freshly collected blood and tissue, cryopreserved PBMCs and tissue MNCs, enriched CD4+ T cell pellets, extracted DNA/RNA, and dissociated tissue mononuclear cells (lymph node, gut, spleen) from NHP studies. Accelevir provides sample type specific shipping protocols and temperature monitoring upon request. Accelevir’s intake procedures require that all samples originate from regulated facilities compliant with applicable guidelines.
Do you provide regulatory support for IND submissions?
Yes. Accelevir provides analytical qualification documentation, including characterization of accuracy, precision, specificity, sensitivity, limit of detection, and limit of quantification for each SIV/SHIV assay. Data packages include control performance summaries and method descriptions formatted for inclusion in sponsor submissions. Accelevir scientists are available for technical consultation on bioanalytical strategy and can support pre-IND meetings with analytical method review. The lab maintains documented procedures for negative controls, positive template controls, mock extractions, and replicate consistency that address the expectations of review committees and regulatory agencies.
Plan Your NHP Study

Build an Integrated Bioanalytical Strategy

Your SIV/SHIV study demands bioanalytical methods with the sensitivity, specificity, and regulatory rigor that match the scientific investment in your NHP program. Accelevir brings validated IPDA, cell-associated RNA, and immune monitoring assays – adapted from the most widely published human HIV-1 assays – directly to your preclinical research.
What we'll cover

Scientific consultation

Baltimore, Maryland · CAP/CLIA-certified, BSL-2+ laboratory
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