
Molecular Diagnostics Labs in South Africa
Engineering Excellence & Technical Support
Molecular Diagnostics Labs solutions for Clinical & Diagnostic Labs. High-standard technical execution following OEM protocols and local regulatory frameworks.
Next-Generation Sequencing (NGS) for Precision Medicine
Leveraging cutting-edge NGS technology, we provide comprehensive genomic profiling for personalized cancer treatment, infectious disease surveillance, and rare genetic disorder diagnosis, empowering South African clinicians with actionable insights.
Rapid Point-of-Care (POC) Testing Solutions
Deploying advanced POC molecular assays across South Africa, we deliver rapid and accurate diagnoses for infectious diseases like HIV, TB, and malaria directly at the patient's bedside, enhancing accessibility and timely intervention in remote and underserved communities.
Integrated Bioinformatics and Data Analytics
Our robust bioinformatics pipeline transforms raw molecular data into interpretable clinical reports, supporting epidemiological studies, drug resistance monitoring, and the development of novel diagnostic markers tailored to the unique South African healthcare landscape.
What Is Molecular Diagnostics Labs In South Africa?
Molecular diagnostics laboratories in South Africa provide advanced analytical services utilizing the principles of molecular biology to detect and characterize biological molecules, primarily nucleic acids (DNA and RNA) and proteins. These facilities play a critical role in modern healthcare and research by offering precise, sensitive, and specific diagnostic information that underpins disease detection, diagnosis, prognosis, and treatment selection. The services involve a range of techniques, including Polymerase Chain Reaction (PCR) and its variants (e.g., real-time PCR), DNA sequencing, hybridization assays, and increasingly, next-generation sequencing (NGS). These methodologies enable the identification of genetic mutations, pathogens (viruses, bacteria, fungi, parasites), gene expression profiles, and pharmacogenomic markers. The demand for these services stems from various sectors, including clinical medicine, public health, infectious disease surveillance, oncology, genetic screening, and forensic science.
| Who Needs Molecular Diagnostics | Typical Use Cases | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Hospitals and Clinics: Physicians and specialists for patient management. | Infectious Disease Diagnosis: Identification of viral (e.g., HIV, HBV, HCV, SARS-CoV-2), bacterial (e.g., Tuberculosis, MRSA), and parasitic (e.g., Malaria) infections. Monitoring viral load for treatment efficacy. | Oncology: Detection of cancer-specific mutations for diagnosis, prognosis, and targeted therapy selection (e.g., EGFR mutations in lung cancer, BRAF mutations in melanoma). Monitoring minimal residual disease. | Genetic Disorders: Diagnosis of inherited conditions (e.g., cystic fibrosis, sickle cell anemia), prenatal screening, and carrier testing. | Pharmacogenomics: Predicting drug response and potential adverse reactions based on an individual's genetic makeup, optimizing drug selection and dosage. | Immunology: HLA typing for organ transplantation, diagnosis of autoimmune diseases. | Forensic Science: DNA profiling for identification in criminal investigations and paternity testing. | Public Health Agencies: Disease surveillance, outbreak investigations, and monitoring of antimicrobial resistance patterns. | Research Institutions: Investigating disease mechanisms, developing new diagnostic markers, and drug discovery. | Fertility Clinics: Preimplantation genetic diagnosis (PGD) and screening (PGS). |
Key Aspects of Molecular Diagnostics Labs in South Africa
- Core Technologies: Primarily PCR (qualitative and quantitative), DNA sequencing (Sanger, NGS), microarrays, and immunoassays targeting molecular markers.
- Sample Types: Blood, saliva, tissue biopsies, urine, cerebrospinal fluid, swabs, and other biological specimens.
- Data Interpretation: Analysis of raw molecular data to provide actionable diagnostic or prognostic reports.
- Quality Assurance: Strict adherence to international standards (e.g., ISO 15189) for accredited laboratory practice.
- Regulatory Compliance: Operation under national health and safety regulations.
Who Needs Molecular Diagnostics Labs In South Africa?
Molecular diagnostics labs in South Africa are crucial for accurate and timely disease detection, patient management, and public health initiatives. They leverage advanced techniques to identify specific genetic material or proteins associated with pathogens, genetic disorders, and cancer markers. This precision is vital for a wide range of applications, from diagnosing infectious diseases and monitoring treatment efficacy to prenatal screening and personalized medicine. The demand for these specialized services spans various sectors within the South African healthcare landscape and beyond, driven by the need for definitive diagnostic answers and improved health outcomes.
| Customer Type | Key Departments/Applications | Primary Needs/Benefits |
|---|---|---|
| Hospitals & Clinics | Infectious Disease Units, Critical Care, Oncology, Obstetrics & Gynecology, Pediatrics | Rapid and accurate diagnosis of infections (TB, HIV, COVID-19, sepsis), antibiotic resistance, cancer markers, prenatal screening, genetic disease identification. |
| Pathology Laboratories | Microbiology, Virology, Genetics, Oncology | Referral testing for specialized molecular assays, confirmation of complex diagnoses, genetic testing, viral load monitoring. |
| Public Health & Government | National Health Laboratory Service (NHLS), Department of Health, Provincial Health Departments | Disease surveillance, outbreak response, epidemic control, national screening programs (e.g., newborn screening), public health policy development. |
| Research & Academia | Genetics Departments, Medical Research Institutes, University Faculties | Gene sequencing, disease mechanism research, drug discovery, clinical trial support, molecular epidemiology. |
| Biotech & Pharma | Research & Development (R&D), Clinical Operations, Diagnostics Development | Companion diagnostics, pharmacogenomics, drug target validation, biomarker discovery, clinical trial sample analysis. |
| Private Healthcare & Medical Aid | Specialist Practices, Private Hospitals, Medical Aid Administrators | Accurate diagnosis for effective treatment, personalized medicine, improved patient outcomes, evidence-based reimbursement decisions. |
| Forensic Science | Crime Scene Investigation, DNA Analysis Units | DNA profiling for criminal investigations, identification of individuals, paternity testing. |
Who Needs Molecular Diagnostics Labs in South Africa? Target Customers and Departments
- Hospitals and Clinics: Essential for rapid diagnosis of infectious diseases (e.g., TB, HIV, COVID-19), antibiotic resistance profiling, and identifying genetic predispositions to certain conditions.
- Pathology Laboratories: Serve as a core referral point for complex diagnostic testing that requires specialized molecular techniques, complementing traditional pathology services.
- Public Health Institutions and Government Health Departments: Crucial for disease surveillance, outbreak investigations, national screening programs (e.g., newborn screening), and monitoring public health trends.
- Research Institutions and Universities: Support groundbreaking research in genetics, infectious diseases, oncology, and drug development, requiring advanced molecular analysis.
- Pharmaceutical and Biotechnology Companies: Utilized for clinical trials, drug efficacy testing, companion diagnostics development, and pharmacogenomics studies.
- Private Healthcare Providers and Medical Aid Companies: Increasingly relying on molecular diagnostics for accurate diagnosis, cost-effective treatment selection, and evidence-based healthcare delivery.
- Forensic Science Laboratories: Employed for DNA profiling in criminal investigations, paternity testing, and identification of victims.
- Individual Patients (indirectly): Benefit from accurate diagnoses leading to personalized and effective treatment plans, often facilitated through their healthcare providers.
Molecular Diagnostics Labs Process In South Africa
Molecular diagnostics laboratories in South Africa follow a structured workflow to ensure accurate and timely testing. This process begins with a patient's sample and inquiry, progressing through various stages of preparation, analysis, and reporting. The specific steps can vary slightly depending on the type of test being performed and the laboratory's internal protocols, but the general framework remains consistent.
| Stage | Description | Key Activities | Involved Personnel | Quality Control Points |
|---|---|---|---|---|
| Inquiry/Test Request | The process starts when a healthcare provider or patient requests a specific molecular diagnostic test. This often involves a referral or a direct request based on clinical suspicion. | Completing the test request form, verifying patient details, selecting the appropriate test, and ensuring pre-authorization (if applicable). | Healthcare Provider, Reception Staff | Correct patient identification, accurate test selection. |
| Sample Collection and Transportation | Appropriate biological samples (e.g., blood, urine, saliva, swabs, tissue biopsies) are collected from the patient using sterile techniques. | Collection of sample in the correct container, proper labeling with patient identifiers, adherence to temperature requirements during transport, and chain of custody documentation. | Healthcare Provider, Phlebotomist, Courier Services | Sample integrity, correct labeling, timely delivery. |
| Sample Reception and Pre-analytical Processing | Upon arrival at the laboratory, samples are logged, checked for integrity and completeness, and prepared for analysis. | Receiving and accessioning samples into the Laboratory Information Management System (LIMS), visual inspection for leakage or damage, aliquoting if necessary, and initial triage based on test priority. | Laboratory Technicians, Reception Staff | Accurate LIMS entry, sample integrity check, proper storage conditions. |
| Nucleic Acid Extraction | DNA or RNA is isolated from the biological sample. This is a critical step to remove inhibitors and concentrate the genetic material for subsequent amplification. | Performing manual or automated extraction protocols using commercial kits, ensuring adequate yield and purity of nucleic acids, and storing extracted nucleic acids appropriately. | Laboratory Technicians | Extraction kit validation, absorbance readings (OD260/280), successful extraction yield. |
| Amplification and Detection | The target genetic material is amplified using techniques like Polymerase Chain Reaction (PCR) or quantitative PCR (qPCR). Detection methods vary based on the test (e.g., gel electrophoresis, fluorescence, sequencing). | Preparing reaction mixes, performing thermal cycling on the thermocycler, running the amplification product on detection instruments, and generating raw data. | Laboratory Technicians, Molecular Biologists | Reagent quality control, positive and negative controls, amplification curves, melt curves (for qPCR). |
| Data Analysis and Interpretation | The raw data generated from the detection instruments is analyzed to identify the presence or absence of the target genetic sequence and to quantify it if applicable. | Using specialized software to analyze amplification curves, sequence data, or other relevant outputs. Comparing results against established reference ranges and clinical guidelines. | Molecular Biologists, Pathologists | Software validation, blinded data review, comparison with internal and external quality controls. |
| Reporting and Communication | The results are compiled into a clear and concise report, which is then communicated to the requesting healthcare provider. | Generating a formal laboratory report, including patient demographics, test performed, results, interpretive comments, and any limitations. Disseminating reports via LIMS, secure email, or fax. | Pathologists, Laboratory Managers, Administrative Staff | Accuracy of reported results, timely release of reports, secure communication channels. |
| Quality Assurance and Accreditation | Continuous monitoring and improvement of all laboratory processes to ensure accuracy, reliability, and compliance with national and international standards. | Participation in External Quality Assessment (EQA) schemes, internal audits, instrument calibration and maintenance, staff training, and adherence to Good Laboratory Practices (GLP). | Quality Assurance Officer, Laboratory Management, All Staff | Regular EQA participation, documentation of all QA activities, audit findings and corrective actions. |
Key Stages in Molecular Diagnostics Lab Process (South Africa)
- Sample Reception and Pre-analytical Processing
- Nucleic Acid Extraction
- Amplification and Detection (e.g., PCR, qPCR, sequencing)
- Data Analysis and Interpretation
- Reporting and Communication
Molecular Diagnostics Labs Cost In South Africa
The cost of molecular diagnostics in South Africa is influenced by a variety of factors, leading to a wide range in pricing for common tests. These factors can be broadly categorized into test complexity, technology utilized, reagent and equipment costs, laboratory overheads, and the specific healthcare provider or medical scheme involved. Simpler tests, such as those for common viral infections, tend to be less expensive than highly specialized genetic analyses or multiplex PCR assays capable of detecting multiple pathogens simultaneously. The choice of technology, whether it's traditional PCR, real-time PCR (qPCR), or next-generation sequencing (NGS), significantly impacts cost, with NGS generally being the most expensive due to the sophisticated instrumentation and bioinformatics required. Reagent and consumable costs, including primers, probes, enzymes, and extraction kits, are a direct contributor. Laboratories also face overheads such as personnel salaries, equipment maintenance, quality control, and regulatory compliance, all of which are factored into the final price. Furthermore, the contractual agreements between laboratories and medical aid schemes can result in negotiated rates that differ from the publicly advertised or out-of-pocket prices. Therefore, the price for a molecular diagnostic test in South Africa can vary considerably.
| Molecular Diagnostic Test Category | Estimated Price Range (South African Rand - ZAR) | Notes |
|---|---|---|
| Routine Viral PCR (e.g., Influenza, RSV) | ZAR 800 - ZAR 1,500 | Commonly performed, relatively straightforward assays. |
| COVID-19 PCR Test | ZAR 750 - ZAR 1,200 | Pricing has stabilized significantly post-pandemic, with variations based on turnaround time. |
| Bacterial Pathogen Detection (e.g., UTI pathogens, Meningitis panel) | ZAR 1,000 - ZAR 2,500 | Can involve multiplex panels for broader coverage. |
| Sexually Transmitted Infections (STI) Panel (Multiplex PCR) | ZAR 1,500 - ZAR 3,000 | Detects multiple STIs simultaneously, offering efficiency. |
| Tuberculosis (TB) PCR (e.g., GeneXpert) | ZAR 600 - ZAR 1,000 | Often subsidized or covered by national health programs for specific indications. |
| Human Papillomavirus (HPV) Genotyping | ZAR 1,200 - ZAR 2,000 | Focuses on identifying high-risk HPV strains. |
| Hepatitis Panel (e.g., B, C, E) | ZAR 1,000 - ZAR 2,000 | Detects various hepatitis viruses. |
| Genetic Mutation Analysis (e.g., for pharmacogenomics, inherited conditions) | ZAR 2,500 - ZAR 8,000+ | Highly variable depending on the specific gene(s) and the extent of analysis. |
| Next-Generation Sequencing (NGS) - Targeted Panels | ZAR 5,000 - ZAR 15,000+ | Used for more complex genetic profiling, e.g., cancer gene panels. |
| Whole Genome Sequencing (WGS) - Basic Analysis | ZAR 15,000 - ZAR 50,000+ | Comprehensive genetic analysis, often for research or complex diagnostic cases. |
Key Factors Influencing Molecular Diagnostics Lab Costs in South Africa
- Test Complexity and Scope (e.g., single pathogen vs. multiplex panels, genetic sequencing depth)
- Technology Employed (e.g., PCR, qPCR, Digital PCR, Next-Generation Sequencing)
- Cost of Reagents and Consumables (primers, probes, enzymes, kits)
- Laboratory Infrastructure and Equipment (instrumentation, maintenance, calibration)
- Skilled Personnel and Expertise (salaries, training)
- Quality Assurance and Accreditation (e.g., SANAS, CAP)
- Research and Development (for novel assays)
- Overhead Costs (rent, utilities, administration)
- Volume of Testing (economies of scale)
- Reimbursement Rates from Medical Aid Schemes
- Geographic Location of the Laboratory
Affordable Molecular Diagnostics Labs Options
Accessing affordable molecular diagnostics labs is crucial for timely and accurate disease detection, personalized treatment, and public health surveillance. Many providers now offer flexible pricing models and cost-saving strategies to make these essential services more accessible. Understanding these options can empower individuals and organizations to make informed decisions. This guide explores common approaches to making molecular diagnostics more affordable.
| Cost-Saving Strategy | Description | Target Audience/Benefit |
|---|---|---|
| Value Bundles | Pre-packaged sets of tests at a discounted rate. | Hospitals, clinics, and patients needing multiple related tests. |
| Volume Discounts | Lower per-test cost for higher order volumes. | Large healthcare systems, research institutions, public health departments. |
| Subscription Models | Recurring fee for access to a defined set of tests or unlimited usage. | Organizations with consistent testing needs, startups, research projects. |
| Partnership Programs | Negotiated rates through collaborations with insurers or providers. | Insurance providers, integrated healthcare networks, patient advocacy groups. |
| Outsourced Testing | Leveraging specialized, high-volume labs for cost efficiencies. | Smaller clinics, hospitals without extensive in-house capabilities. |
| Managed Services | Comprehensive lab management by a third-party provider. | Healthcare facilities seeking to reduce operational burden and ensure quality. |
| Technology Optimization | Utilizing efficient, automated, and high-throughput platforms. | All end-users benefit from reduced overall costs. |
| Telehealth Integration | Streamlined testing pathways combined with remote consultations. | Patients in remote areas, individuals seeking convenient testing. |
| Strategic Sourcing | Optimized procurement of reagents and supplies. | Directly impacts lab operating costs, leading to lower test prices. |
| Grant Funding | Subsidized testing costs through external financial support. | Public health programs, research initiatives, underserved communities. |
Understanding Value Bundles and Cost-Saving Strategies
- {"title":"Value Bundles","description":"Value bundles package multiple molecular diagnostic tests or services together at a reduced price compared to purchasing each test individually. These are often designed around specific clinical needs, disease areas, or patient pathways."}
- {"title":"Volume Discounts","description":"Labs often provide tiered pricing where the cost per test decreases as the volume of tests ordered increases. This is particularly beneficial for larger healthcare systems, research institutions, or public health programs."}
- {"title":"Subscription Models","description":"Some providers offer subscription-based access to molecular diagnostic services. This involves a recurring fee (monthly, quarterly, or annually) for a set number of tests or unlimited access to a specific panel, offering predictable costs."}
- {"title":"Partnership Programs","description":"Collaborations between labs and healthcare providers, insurance companies, or patient advocacy groups can lead to negotiated pricing, bulk purchasing agreements, and co-funded testing initiatives."}
- {"title":"Outsourced Testing & Centralized Labs","description":"Instead of maintaining in-house molecular labs, organizations can partner with larger, specialized centralized labs. These labs benefit from economies of scale, leading to lower per-test costs."}
- {"title":"Managed Services","description":"This model involves a provider managing all aspects of molecular diagnostics for a healthcare facility, including equipment, reagents, staffing, and quality control, often at a predictable cost per patient or service."}
- {"title":"Technology Optimization","description":"Labs that invest in efficient, high-throughput technologies and automation can reduce labor and reagent costs, translating into more affordable testing for end-users."}
- {"title":"Telehealth Integration","description":"Integrating molecular testing with telehealth platforms can reduce overhead associated with in-person consultations and streamline the testing process, potentially lowering overall costs."}
- {"title":"Strategic Sourcing & Reagent Management","description":"Efficient inventory management, bulk purchasing of reagents, and negotiating favorable terms with suppliers are critical cost-saving measures for diagnostic labs."}
- {"title":"Government & Grant Funding","description":"Accessing grants from government agencies or private foundations can subsidize the cost of molecular diagnostics, especially for public health initiatives, research, or underserved populations."}
Verified Providers In South Africa
In South Africa, the healthcare landscape is rapidly evolving, and access to verified, high-quality healthcare providers is paramount. Franance Health stands out as a leading platform dedicated to connecting individuals with credentialed and reliable healthcare professionals. Their rigorous verification process ensures that all listed providers meet stringent standards for qualifications, experience, and ethical practice. This commitment to verification provides patients with peace of mind, knowing they are engaging with legitimate and competent healthcare experts. Choosing a verified provider through Franance Health is not just a matter of convenience; it's an investment in your well-being, guaranteeing a higher standard of care and a safer healthcare journey.
| Credential Verification Aspect | Franance Health's Standard | Benefit to Patients |
|---|---|---|
| Professional Licenses and Registrations | Thoroughly checked against relevant South African regulatory bodies (e.g., HPCSA, SANC). | Ensures providers are legally authorized and recognized to practice. |
| Academic and Professional Qualifications | Verified degrees, diplomas, and specialist certifications from accredited institutions. | Confirms providers possess the necessary theoretical knowledge and specialized skills. |
| Work Experience and Professional History | Review of past employment and practice history for continuity and reputability. | Indicates a track record of consistent and reliable service. |
| Background Checks and Criminal Record Verification | Standard background checks to ensure patient safety and ethical conduct. | Protects patients from potentially harmful or unethical practitioners. |
| Continuing Professional Development (CPD) | Confirmation of ongoing commitment to updating knowledge and skills. | Guarantees that providers are current with the latest medical advancements and best practices. |
Why Franance Health Verified Providers are the Best Choice:
- Unparalleled Patient Safety and Trust
- Access to Competent and Qualified Professionals
- Streamlined and Efficient Healthcare Navigation
- Commitment to Ethical Medical Practices
- Empowerment of Informed Healthcare Decisions
Scope Of Work For Molecular Diagnostics Labs
This document outlines the Scope of Work (SOW) for molecular diagnostics laboratories, detailing technical deliverables and standard specifications. It aims to provide a comprehensive framework for establishing, operating, and maintaining high-quality molecular diagnostic services.
| Technical Deliverable | Standard Specifications/Key Parameters | Description | Associated Documentation |
|---|---|---|---|
| Sample Collection and Handling Protocols | Specimen integrity, appropriate collection devices, transport conditions (temperature, time), labeling accuracy, chain of custody. | Ensuring collected samples are suitable for molecular testing, minimizing degradation and contamination. | SOPs for Sample Collection, Specimen Transport Policy, Chain of Custody Forms. |
| Sample Accessioning and Tracking System | Unique sample identifiers, LIS integration, real-time tracking, audit trails. | System for registering, cataloging, and monitoring the status of each sample throughout its lifecycle in the lab. | LIS User Manual, Accessioning SOPs, Audit Log Reports. |
| Assay Validation Reports | Sensitivity, specificity, accuracy, precision (intra- and inter-assay), linearity, limit of detection (LoD), limit of quantitation (LoQ), interference studies, reference range establishment. | Demonstration that an assay performs as intended and reliably detects the target analyte. | Assay Validation Protocols, Validation Reports, Certificate of Analysis for validated assays. |
| Quality Control (QC) Procedures | Frequency of QC testing, control material specifications, acceptable QC ranges, corrective action procedures for out-of-spec results. | Regular testing to monitor the performance of instruments and reagents and ensure the accuracy of test results. | QC SOPs, QC Charts, Lot-specific QC Data Sheets. |
| Instrument Calibration and Maintenance Logs | Calibration schedules, calibration standards, preventive maintenance procedures, performance verification records, repair logs. | Ensuring diagnostic instruments are functioning optimally and generating accurate results. | Instrument Manuals, Calibration SOPs, Maintenance Logs, Performance Verification Records. |
| Reagent Inventory and Management | Expiration date tracking, storage conditions, lot traceability, QC of incoming reagents. | Ensuring reagents are stored correctly, within their shelf-life, and performing as expected. | Reagent Management SOPs, Inventory Logs, Reagent QC Records. |
| Test Result Reporting Format | Clarity, completeness, inclusion of patient demographics, ordering physician, test performed, result, units, reference ranges, critical values, interpretation notes, laboratory accreditation information. | Standardized format for communicating test results to clinicians in a clear and actionable manner. | Reporting SOPs, Sample Report Templates. |
| Proficiency Testing (PT) Program Participation | Regular participation in accredited PT programs, timely submission of results, review of PT reports and corrective actions. | External assessment of laboratory performance against peer laboratories. | PT Provider Certificates, PT Performance Reports, Corrective Action Plans. |
| Standard Operating Procedures (SOPs) | Detailed, written instructions for all laboratory procedures, including pre-analytical, analytical, and post-analytical phases. Review and update schedule. | Documented, consistent methods for performing all laboratory tasks. | Master SOP Index, Individual SOP Documents (version controlled). |
| Competency Assessment Records | Initial and ongoing competency assessments for all laboratory personnel, documented observation and evaluation. | Verification that personnel possess the necessary knowledge and skills to perform their assigned duties. | Competency Assessment Forms, Personnel Training Records. |
| Biosafety Manual and Incident Reports | Risk assessment, containment levels, personal protective equipment (PPE) guidelines, waste disposal procedures, spill management, incident reporting mechanisms. | Protocols to ensure the safety of laboratory personnel and the public from biological hazards. | Biosafety Manual, Incident Report Forms, Training Records on Biosafety. |
| Information System Validation Reports | Validation of LIS, EMR integration, data security, backup and recovery procedures, audit trails. | Ensuring the reliability, accuracy, and security of laboratory information systems. | LIS Validation Protocol, Validation Reports, Disaster Recovery Plan. |
Key Areas of Molecular Diagnostics Laboratory Operations
- Pre-analytical Phase Management
- Analytical Phase (Testing) Execution
- Post-analytical Phase Reporting and Interpretation
- Quality Assurance and Quality Control (QA/QC)
- Instrumentation and Reagent Management
- Data Management and Information Technology (IT) Integration
- Personnel Training and Competency Assessment
- Biosafety and Biosecurity Protocols
- Regulatory Compliance and Accreditation
Service Level Agreement For Molecular Diagnostics Labs
This Service Level Agreement (SLA) outlines the agreed-upon response times and uptime guarantees for the molecular diagnostics laboratory services provided by [Your Company Name] (hereinafter referred to as 'Provider') to [Client Name] (hereinafter referred to as 'Client'). This SLA is an integral part of the Master Service Agreement between the Provider and the Client.
| Service Category | Response Time Guarantee (Business Hours) | Uptime Guarantee (Monthly) |
|---|---|---|
| Routine Sample Accessioning & Initial Processing | Within 2 business hours of sample receipt | 99.5% |
| Routine Test Initiation | Within 4 business hours of sample accessioning | 99.5% |
| Routine Report Availability | Within [X] business days of test initiation (specific to test type, see Appendix A) | N/A (Report delivery is dependent on test duration) |
| STAT Sample Accessioning & Initial Processing | Within 1 business hour of sample receipt | 99.8% |
| STAT Test Initiation | Within 2 business hours of sample accessioning | 99.8% |
| STAT Report Availability | Within [Y] business hours of test initiation (specific to test type, see Appendix B) | N/A (Report delivery is dependent on test duration) |
| Technical Support Availability | Phone: Within 30 minutes during business hours; Email: Within 4 business hours | 99.9% |
| System Uptime (Laboratory Information System & Instrument Availability) | N/A (Covered by System Uptime Guarantee) | 99.8% |
Scope of Services Covered
- Routine molecular diagnostic testing (e.g., PCR, sequencing, FISH).
- STAT (urgent) molecular diagnostic testing.
- Sample accessioning and processing.
- Report generation and delivery.
- Technical support and consultation.
Frequently Asked Questions

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