Laboratory and In Vitro Diagnostic Equipment: Basic Equipment Categories in the Laboratory

Laboratory equipment does not consist only of benchtop analyzers or large automated systems. For a specimen to be collected, transported, received, processed, analyzed, and reported, laboratories also require specimen collection and transport equipment, centrifuges, cold storage systems, biological safety cabinets, volumetric measurement devices, specialized analyzers, data management software, and a range of supporting infrastructure.

In vitro diagnostic medical devices, commonly referred to as IVDs, are used to analyze specimens taken from the human body, such as blood, serum, plasma, urine, or other types of biological samples. Results may support disease detection, health monitoring, or provide information for clinical and laboratory activities. IVDs may range from simple test kits and handheld devices to complex laboratory analysis systems.

Healthcare facilities should therefore evaluate the entire laboratory workflow rather than selecting individual instruments in isolation. Even a high-throughput system can be disrupted if pre-analytical processes are slow, reagent supply is unstable, data cannot be integrated, or an appropriate maintenance plan is unavailable.

Quick Summary

- Laboratory equipment is distributed across three stages: pre-analytical, analytical, and post-analytical.
- IVD medical devices are not limited to analyzers and may also include reagents, calibrators, quality control materials, software, and related accessories.
- Common analyzer categories include hematology, clinical chemistry, immunoassay, coagulation, microbiology, molecular diagnostics, urinalysis, and point-of-care testing.
- Equipment selection should be based on the test menu, sample volume, turnaround time, specimen volume, infrastructure, and reagent supply capability.
- Stability of the overall workflow is more important than the maximum throughput of an individual analyzer.
- LIS, barcode systems, and connectivity play an important role in reducing manual data entry and improving specimen traceability.

What Equipment Does a Laboratory Specimen Pass Through?

To understand laboratory structure, it is useful to follow the journey of a specimen.

First, the specimen is collected, identified, and transported to the laboratory. After receipt, it may be sorted, centrifuged, aliquoted, stored, or otherwise prepared. It is then loaded onto the appropriate analyzer according to the requested test. Results from the analyzer are subsequently reviewed, transferred to the management system, validated, and returned to the requesting unit.

This process is commonly divided into three stages:

Stage	Main Activities	Common Equipment Groups
Pre-analytical	Specimen collection, identification, transport, centrifugation, aliquoting, and storage	Collection devices, centrifuges, refrigerators, freezers, pipettes, aliquoting systems, barcode systems
Analytical	Measurement, detection, or identification of components in the specimen	Hematology, clinical chemistry, immunoassay, coagulation, microbiology, and molecular diagnostic analyzers
Post-analytical	Review, storage, transmission, and reporting of results	LIS, equipment management software, specimen storage systems, servers, and connectivity platforms

If a bottleneck occurs at any of these three stages, overall laboratory performance may decline even when the main analyzer is functioning normally.

For example, a clinical chemistry analyzer may process a large number of tests per hour, but the laboratory may still report results slowly if:

- Specimens do not arrive on time.
- Labels are difficult to read or contain incorrect information.
- Centrifuge capacity is insufficient.
- Staff must re-enter data manually.
- Specimens wait for manual aliquoting.
- Reagents are not prepared at the appropriate time.
- Results require multiple validation steps.
- The LIS or data network is interrupted.

A specimen-flow approach helps hospitals identify the equipment they actually need and avoid allocating most of the budget to analyzers alone.

How Are In Vitro Diagnostic Medical Devices Different from General Laboratory Equipment?

In everyday communication, “laboratory equipment” often refers to machines used in the laboratory. In vitro diagnostic medical devices, however, have a broader scope.

An IVD system may include:

- Analyzers.
- Test kits.
- Reagents.
- Calibrators.
- Quality control materials.
- Specimen collection and processing devices.
- Software that plays a role in the testing process.
- Specialized accessories.
- Signal reading or interpretation components.
- Rapid testing devices.

WHO describes IVDs as tests performed on specimens outside the body and used in laboratories, healthcare facilities, or at home. Products may range from simple handheld tests to complex laboratory systems.

Because the scope is broad, two products serving the same testing area may differ significantly in:

- Level of automation.
- Analytical method.
- Sample volume.
- Turnaround time.
- Storage conditions.
- Connectivity.
- Calibration requirements.
- Reagent shelf life.
- Staffing requirements.
- Suitability for centralized laboratories or point-of-care use.

When planning procurement, facilities should evaluate the analyzer, reagents, and related components as a complete system.

The Pre-Analytical Stage: Where Many Errors Can Begin

The pre-analytical stage covers the period from the test request until the specimen is ready to be loaded onto the analyzer.

This stage often receives less attention during equipment investment planning, even though it directly affects specimen quality and processing time.

Specimen Collection and Identification Equipment

This group may include:

- Collection tubes.
- Needles and collection sets.
- Tube racks.
- Labeling devices.
- Barcode printers.
- Barcode scanners.
- Specimen reception systems.
- Devices for recording collection times.
- Specimen transport boxes or bags.

The goal is to ensure consistent specimen identification from collection through result reporting.

If labels are handwritten or data must be re-entered several times, the risk of specimen mix-ups and data errors may increase. Barcode systems can link specimens to test requests, but facilities still need procedures for damaged labels, duplicate codes, or specimens with incomplete information.

Specimen Transport Equipment

Specimens may be transported using:

- Specialized transport containers.
- Storage bags.
- Temperature-controlled devices.
- Internal transport carts.
- Pneumatic tube systems.
- Temperature data loggers.
- Leak-resistant and impact-resistant containers.

The transport method should be selected based on specimen type, distance, time, temperature requirements, and biosafety considerations.

A rapid transport system may not be appropriate for every specimen type. Facilities should evaluate the potential effects of vibration, pressure, temperature, and transport time on specimen quality before implementation.

Centrifuges

Centrifuges are used to separate specimen components by spinning them at an appropriate speed.

When selecting a centrifuge, laboratories should consider:

- Number of tube positions.
- Rotor type.
- Compatible tube sizes.
- Rotational speed.
- Relative centrifugal force.
- Timer control.
- Temperature control.
- Lid locking mechanism.
- Sample balancing.
- Noise level.
- Ease of cleaning.
- Imbalance alarms.
- Peak-hour capacity.

A laboratory should not rely on a single centrifuge sized only for normal daily workload. If the unit fails, the entire clinical chemistry, immunoassay, or coagulation area may be affected.

Pipettes and Volumetric Measurement Devices

Pipettes are used to aspirate and transfer defined volumes of liquid.

Laboratories may use:

- Single-channel pipettes.
- Multichannel pipettes.
- Electronic pipettes.
- Liquid dispensers.
- Dilution devices.
- Automated aliquoting systems.

Factors to control include:

- Volume range.
- Accuracy.
- Repeatability.
- Compatible tips.
- Ergonomics.
- Ease of cleaning.
- Calibration and checking schedules.
- Compatibility with chemicals or specimen types.

Pipettes may be much smaller than analyzers, but unstable aspiration volumes can still affect test results.

Refrigerators and Freezers

Cold storage equipment may be used for:

- Specimens.
- Reagents.
- Calibrators.
- Control materials.
- Microbial strains.
- Retained samples.
- Products requiring specific temperatures.

Domestic refrigerators should not be treated as a default solution for every laboratory purpose. Facilities should assess:

- Temperature range.
- Temperature uniformity.
- Data logging capability.
- Temperature alarms.
- Backup power.
- Capacity.
- Zoning capability.
- Probe placement.
- Frequency of door opening.
- Contingency plans in case of equipment failure.

Temperature monitoring and remote alarm systems can help detect incidents early, but facilities still need procedures for responding when temperatures exceed established limits.

Automated Pre-Analytical Systems

In high-volume laboratories, automated systems may perform one or more of the following functions:

- Specimen identification.
- Sorting.
- Centrifugation.
- Decapping.
- Aliquoting.
- Labeling secondary tubes.
- Routing specimens to analyzers.
- Recapping.
- Specimen storage.

These systems can reduce manual handling but are most appropriate when specimen volume, available space, test menu, and workflow standardization are sufficient.

If incoming specimens are inconsistent, tube types vary widely, or exception rates are high, automation may not deliver the expected efficiency.

The Analytical Stage: Core Analyzer Categories in the Laboratory

This is the area most users think of when discussing laboratory equipment.

Each specialty has different analytical principles, specimen types, reagents, and performance criteria.

Hematology Analyzers

Hematology analyzers are used to evaluate cellular components in blood.

Depending on configuration, a system may provide:

- Blood cell counts.
- Red blood cell indices.
- White blood cell indices.
- Platelet indices.
- Cell population differentials.
- Histograms or alert signals.
- Information supporting review of abnormal specimens.

When selecting a hematology analyzer, laboratories should evaluate:

- Number of white blood cell differential parameters.
- Throughput.
- Sample volume.
- Routine and special specimen modes.
- Pediatric sample capability.
- Automated sample loading.
- Alert systems.
- Reagents.
- Reagent stability.
- Cleaning procedures.
- Control materials.
- Slide-making capability or connectivity with a slide preparation system.
- LIS connectivity.

The analyzer does not completely replace morphological review or professional assessment where required. Laboratories should establish procedures for handling flagged specimens and criteria for additional review.

Clinical Chemistry Analyzers

Clinical chemistry analyzers commonly measure chemical components in serum, plasma, urine, or other suitable specimens.

Systems may include:

- Semi-automated analyzers.
- Fully automated analyzers.
- Batch systems.
- Random-access systems.
- Integrated clinical chemistry lines.

Important criteria include:

- Actual throughput.
- Number of reagent positions.
- Number of sample positions.
- Continuous loading capability.
- Emergency sample handling.
- Minimum sample volume.
- Dilution capability.
- Automatic rerun capability.
- Reagent refrigeration.
- Water consumption.
- Wastewater volume.
- Calibration frequency.
- Maintenance frequency.
- Reagent management software.
- Connectivity.

Throughput should not be evaluated only by the maximum number of tests per hour. Laboratories should also consider the number of specimens, number of tests per specimen, calibration time, quality control runs, reagent replacement, and maintenance.

Immunoassay Analyzers

Immunoassay systems are used to detect or quantify substances based on immunological reactions.

Laboratories should assess:

- Detection principle.
- Test menu.
- Turnaround time.
- Emergency sample capability.
- Throughput.
- Continuous sample loading.
- On-board reagent stability.
- Packaging format.
- Calibrators.
- Control materials.
- Degree of automation.
- Storage requirements.
- Connectivity with chemistry systems or integrated laboratory lines.

A system with a broad test menu may still be unsuitable if many assays are rarely used, reagent packs are too large, or open-vial stability is too short.

Coagulation Analyzers

Coagulation analyzers are used for tests relating to coagulation and hemostasis.

Systems may differ in:

- Detection principle.
- Number of measurement channels.
- Throughput.
- Emergency sample capability.
- Interference detection.
- Sample volume.
- Number of reagent positions.
- Incubation conditions.
- Automatic dilution.
- Compatible reagents.
- Control materials.
- Connectivity.

Because coagulation specimens are sensitive to collection, transport, and processing conditions, the analyzer is only one part of the system. Laboratories must also control tube type, sample ratio, centrifugation time, and time to analysis.

Urinalysis Equipment

This category may include:

- Urine strip readers.
- Urine chemistry analyzers.
- Sediment analyzers.
- Microscopy or imaging systems for specimen components.
- Integrated chemistry and sediment systems.

Important evaluation factors include:

- Throughput.
- Automated sample loading.
- Sample volume.
- Parameter menu.
- Effects of color or turbidity.
- Component identification capability.
- Cleaning mechanisms.
- Reagents and consumables.
- Handling of abnormal specimens.
- Data connectivity.

Laboratories should clearly define when additional testing using another method is required rather than relying entirely on automated results.

Microbiology Equipment

Microbiology laboratories may use multiple systems within a single workflow:

- Biological safety cabinets.
- Incubators.
- Culture systems.
- Microscopes.
- Inoculation devices.
- Culture monitoring systems.
- Microorganism identification systems.
- Antimicrobial susceptibility testing systems.
- Mass spectrometry systems where applicable.
- Autoclaves.
- Strain storage equipment.
- Waste treatment systems.

Microbiology equipment should be considered together with:

- Workflow design.
- Biosafety.
- Cross-contamination control.
- Culture temperature and environmental conditions.
- Processing time.
- Identification methods.
- Data management software.
- Database update mechanisms.
- Consumables and culture media.
- Decontamination procedures.

A rapid identification system does not automatically solve the entire workflow if culture, sample preparation, or data management processes remain unstandardized.

Molecular Diagnostic Equipment

Molecular laboratories may use:

- Extraction systems.
- Biological safety cabinets.
- PCR workstations.
- Centrifuges.
- Mixers.
- Conventional PCR systems.
- Real-time PCR systems.
- Integrated amplification systems.
- Electrophoresis equipment.
- Signal detection systems.
- Sequencing systems where appropriate.
- Analysis software.

A key consideration in molecular diagnostics is workflow control and prevention of cross-contamination.

The facility may need separate areas for:

1. Reagent preparation.
2. Specimen receipt and processing.
3. Extraction.
4. Reaction preparation.
5. Amplification.
6. Product analysis.

Facilities should not select equipment first and then try to fit the laboratory around it. Space, power, specimen flow, ventilation, and contamination control requirements should be assessed from the planning stage.

Point-of-Care Testing Equipment

POCT devices are used near the point of patient care rather than exclusively in a central laboratory.

This category may include:

- Blood glucose meters.
- Blood gas analyzers.
- Rapid immunoassay devices.
- Point-of-care coagulation analyzers.
- Handheld analyzers.
- Rapid test kits.

A common advantage is shorter specimen transport and faster access to results near the point of use. However, distributing devices across multiple departments may increase challenges in:

- Operator training.
- Reagent lot management.
- Quality control.
- Maintenance.
- Account management.
- Result connectivity.
- Consumable tracking.
- Error traceability.
- Oversight of devices located outside the laboratory.

POCT should not be implemented simply because the device is small and easy to use. Facilities need to clearly define who is responsible for clinical or laboratory oversight, who monitors quality, and how results are transferred into the patient record.

The Post-Analytical Stage: When Results Leave the Analyzer

The process does not end when the analyzer completes the measurement.

Results still need to be:

- Technically reviewed.
- Checked for alerts.
- Compared with relevant data where appropriate.
- Validated.
- Transmitted to the system.
- Stored.
- Reported to the requesting unit.
- Retrieved when needed.

Laboratory Information System

LIS is an information system used to manage laboratory operations.

Depending on scope, an LIS may support:

- Receiving test requests.
- Generating specimen IDs.
- Tracking specimen locations.
- Sending worklists to analyzers.
- Receiving results from analyzers.
- Managing specimen status.
- Managing users.
- Result validation.
- Recording change history.
- Connecting with HIS or EMR.
- Tracking reagents and consumables.
- Generating reports.
- Monitoring turnaround time.

LIS-connected equipment can reduce manual result entry, but hospitals should clearly define:

- Whether connectivity is one-way or bidirectional.
- Communication protocol.
- Data scope.
- Validation permissions.
- Procedures during network outages.
- Data resynchronization methods.
- Responsibility for integration.
- Acceptance criteria.

A statement that the device “has an LIS connection port” should not be accepted without verifying the required module, licensing, and actual implementation plan.

Automated Result Validation Systems

Some laboratories may configure rules allowing the system to automatically validate results that meet defined conditions.

Rules may consider:

- Value ranges.
- Analyzer flags.
- Quality control results.
- Previous results.
- Degree of change.
- Specimen information.
- Test groups.
- Patient categories.

Automation does not completely replace the responsible laboratory professional. Rules should be developed, tested, approved, and monitored during use.

Specimen Storage Systems

After analysis, specimens may need to be retained for a defined period according to facility procedures.

Equipment may include:

- Refrigerators.
- Freezers.
- Specimen racks.
- Automated storage systems.
- Recapping systems.
- Specimen retrieval systems.
- Location management software.

The system should help determine:

- Where the specimen is stored.
- When it was placed into storage.
- Storage conditions.
- Retention period.
- Who removed it.
- Whether the specimen can be reused.
- When it should be processed for disposal.

Supporting Infrastructure That Is Often Overlooked but Essential

Analyzers may be at the center of laboratory operations, but stable performance depends on many supporting systems.

Water Systems

Some clinical chemistry, immunoassay, or automated systems require water of an appropriate quality.

Facilities should clarify:

- Whether the device includes an integrated water purification system.
- Required input water quality.
- Consumption rate.
- Filter replacement frequency.
- Cleaning procedures.
- How water quality is monitored.
- Backup arrangements.
- How wastewater is handled.

Facilities should not assume that tap water or standard filtered water is suitable for every analyzer.

Power Supply and UPS

Unstable power can interrupt workflows, affect data, or lead to loss of specimens already in process.

Planning should include:

- Power requirements.
- Voltage stabilization.
- UPS.
- Backup generator.
- Backup duration.
- Equipment priority.
- Safe shutdown procedures.
- UPS battery testing.
- Power system maintenance.

For large systems, facilities should assess not only nominal power requirements but also start-up current and total load when multiple devices operate simultaneously.

Air Conditioning and Ventilation

Laboratory equipment can generate heat and may require relatively stable environmental conditions.

Facilities should assess:

- Temperature.
- Humidity.
- Airflow.
- Equipment heat output.
- After-hours operation.
- Contingency plans for air-conditioning failure.
- Room pressure requirements.
- Air vent placement.
- Potential effects on biological safety cabinets.

Biological Safety Cabinets

Biological safety cabinets provide a controlled work area appropriate for specific types of laboratory activities.

They should not be confused with chemical fume hoods or clean benches.

Selection and installation should consider:

- Type of work.
- Required level of protection.
- Cabinet location.
- Staff movement.
- Door locations.
- Ventilation.
- Power supply.
- Maintenance and testing.
- Decontamination procedures.
- User training.

Waste Treatment Equipment

Laboratories may require:

- Autoclaves.
- Decontamination devices.
- Waste containers.
- Waste segregation systems.
- Liquid waste treatment equipment.
- Temporary storage areas.

Waste handling systems should be designed according to specimen types, chemicals, reagents, and applicable requirements.

Select Equipment Based on the Test Menu, Not the Machine Name

A common mistake is to begin by asking “Which analyzer should we buy?” before defining which tests the laboratory needs to perform.

A more appropriate sequence is:

1. Define the test menu.
2. Estimate sample volume.
3. Analyze peak-hour demand.
4. Determine required turnaround times.
5. Determine specimen types and volumes.
6. Assess staffing.
7. Review infrastructure.
8. Select the analytical principle and level of automation.
9. Define analyzers, reagents, and software.
10. Establish a backup plan.

The following table can support the needs assessment stage:

Question	Implication for Equipment Selection
How many specimens are processed each day?	Determines throughput and degree of automation
When do most specimens arrive?	Helps assess peak-hour capacity
Are emergency specimens received?	May require priority positions or a separate system
How broad is the test menu?	Helps determine the number of modules and platforms
Is specimen volume limited?	Important for pediatric or difficult-to-collect samples
Are specimens sent from multiple facilities?	Affects transport, barcoding, and traceability
How quickly are results required?	Influences workflow, equipment, and staffing
How are reagents stored?	Affects cold storage and supply chain requirements
Is LIS connectivity required?	Determines modules and integration costs
What happens if the primary analyzer stops?	Requires backup equipment or a support arrangement

WHO recommends that IVD procurement consider factors beyond product characteristics, including intended use, operating conditions, supply chain, training, technical services, and related costs.

How Do Nominal and Actual Throughput Differ?

Manufacturers commonly specify throughput as the number of tests per hour. Laboratories, however, need to translate this figure into actual specimen-processing capacity.

For example, if an analyzer has a stated throughput of 800 tests per hour, this does not mean it can process 800 specimens per hour because each specimen may require multiple tests.

Actual capacity is also affected by:

- Number of tests per specimen.
- Proportion of emergency samples.
- Sample loading time.
- Reagent replacement time.
- Calibration frequency.
- Quality control time.
- Samples requiring dilution.
- Samples requiring reruns.
- Proportion of abnormal samples.
- Daily maintenance.
- Unplanned downtime.

Facilities should therefore ask suppliers to model throughput using actual testing data rather than comparing maximum stated figures alone.

Reagents Determine Whether the System Can Be Sustained

Analyzers are usually purchased once, while reagents and consumables must be supplied continuously.

Evaluation criteria should include:

- Reagent menu.
- Packaging format.
- Theoretical number of tests.
- Actual number of tests.
- Shelf life.
- Open-vial stability.
- On-board stability.
- Storage conditions.
- Calibration frequency.
- Included calibrators.
- Control materials.
- Wash solutions.
- Ancillary consumables.
- Wastage rate.
- Delivery lead time.
- Availability of alternative supply.
- Contingency plans if a product is discontinued.

A reagent kit with a larger number of tests is not necessarily more economical if testing volume is low and the remaining reagent expires before it can be fully used.

WHO considers procurement and inventory management an important component of laboratory quality management because testing depends on the continuous availability of required reagents, supplies, and other goods.

Maintenance, Calibration, and Quality Control Should Be Considered from the Beginning

When evaluating equipment, laboratories should ask suppliers to clarify:

- Daily maintenance requirements.
- Weekly and monthly maintenance.
- Time required.
- Maintenance consumables.
- Components that users can replace.
- Tasks that must be performed by engineers.
- Preventive maintenance frequency.
- Calibration frequency.
- Types of calibrators.
- Required downtime.
- Spare parts inventory.
- Response time.
- Remote support.
- Post-warranty costs.

WHO recommends that laboratories establish a preventive maintenance program covering equipment inventories, maintenance schedules, calibration, troubleshooting, and repairs.

A high-throughput analyzer that requires lengthy daily maintenance may provide lower actual processing capacity than expected.

Data Connectivity Should Be Considered Part of the Configuration

In a modern laboratory, an analyzer is not only a testing instrument but also a data node.

Technical specifications should define:

- Whether the analyzer supports connectivity.
- Whether the connection is one-way or bidirectional.
- Communication protocol.
- Whether alerts can be transmitted.
- Whether worklists can be received.
- Whether quality control data can be transmitted.
- Whether device logs can be exported.
- Whether connectivity software is included.
- Whether recurring license fees apply.
- Who is responsible for integration.
- How connectivity will be accepted.
- Contingency procedures when the LIS is unavailable.

If these issues are addressed only after equipment purchase, hospitals may face additional costs, delayed implementation, or prolonged manual data entry.

Purchase, Lease, or Reagent-Rental Model?

Laboratories may access equipment through several models:

- Equipment purchase.
- Equipment lease.
- Service outsourcing.
- Reagent-rental arrangements with equipment placement.
- Reagent or chemical purchases bundled with equipment use rights.
- Other appropriate collaboration models.

Each model distributes costs and responsibilities differently.

Model	Potential Advantages	Issues to Clarify
Equipment purchase	Greater control over assets and configuration	Capital investment, maintenance, spare parts, and technology risk
Equipment lease	Lower initial capital requirements	Lease term, return conditions, and repair responsibilities
Reagent-rental model	May link equipment availability with reagent supply	Volume commitments, reagent pricing, contract duration, and flexibility to change
Service outsourcing	Payment based on service scope	Quality control, data, staffing, and professional responsibilities

The model should not be selected solely based on whether the facility must pay for the equipment upfront. Total cost, contract duration, minimum volume commitments, reagent prices, data ownership, technical services, and exit arrangements should all be evaluated.

Bottlenecks That Often Appear Only After Installation

Analyzer Capacity Exceeds Pre-Analytical Capacity

Specimens still need to be manually aliquoted, labeled, or centrifuged, leaving the analyzer waiting for samples.

Reagent Packaging Is Unsuitable

Low testing volume causes reagents to exceed their open-vial stability before they are fully used.

Calibrators or Control Materials Are Unavailable

The analyzer may be operational but cannot support the planned quality procedures.

The System Cannot Connect to the LIS

Staff must manually enter orders and results, increasing workload.

Water or Power Infrastructure Is Unstable

The analyzer may frequently generate alerts, stop operating, or require additional maintenance.

Spare Parts Must Be Imported

Downtime becomes prolonged, and specimens may need to be sent to another facility.

Staff Have Not Been Adequately Trained

Only a small number of employees can operate the system, creating difficulties during shift changes or staff absence.

There Is No Backup Plan for Primary Analyzer Downtime

The laboratory may need to suspend a group of tests or send specimens elsewhere.

These issues demonstrate that laboratory equipment procurement should be integrated with operational design rather than treated as a standalone equipment purchase.

How to Build a Scalable Laboratory

A scalable laboratory does not necessarily need to invest in the largest configuration from the beginning.

More important is a design that allows the facility to:

- Add modules.
- Expand the test menu.
- Increase sample positions.
- Connect additional analyzers.
- Expand LIS capacity.
- Add cold storage.
- Increase power capacity.
- Modify specimen flow.
- Add pre-analytical areas.
- Change suppliers where necessary.
- Export data from legacy systems.
- Train additional users.

During planning, hospitals should forecast:

- Testing volume over the next three to five years.
- New services.
- Potential to receive specimens from other facilities.
- Automation trends.
- Integration needs.
- Available expansion space.
- Potential changes in procurement models.

Facilities should not select a system that barely meets current needs when rapid growth is expected, but they should also avoid investing in excessive capacity without a clear utilization plan.

Criteria for Comparing Laboratory Solutions

Clinical and Laboratory Capability

- Test menu.
- Analytical principle.
- Specimen types.
- Measurement range.
- Sample volume.
- Turnaround time.
- Performance appropriate for intended use.

Operational Capability

- Throughput.
- Emergency sample handling.
- Continuous sample loading.
- Handling of abnormal specimens.
- Degree of automation.
- Number of operator steps.
- Maintenance time.
- Start-up time.

Reagent Ecosystem

- Packaging format.
- Shelf life.
- Open-vial stability.
- On-board stability.
- Calibrators.
- Control materials.
- Ancillary consumables.
- Supply availability.
- Pricing and price-adjustment mechanisms.

Infrastructure

- Electricity.
- Water.
- Temperature.
- Humidity.
- Ventilation.
- Space.
- Biosafety.
- Waste.
- Network connectivity.

Data

- LIS connectivity.
- Communication standards.
- Account management.
- Logs.
- Backup.
- Data export.
- Software updates.
- Licensing fees.

Technical Services

- Warranty.
- Maintenance.
- Response time.
- Regional engineering support.
- Spare parts inventory.
- Backup equipment.
- Training.
- Post-warranty support.

IVD procurement should be assessed according to the specific conditions of each laboratory. WHO notes that product selection should consider quality, performance, implementation feasibility, supply chain, and total system cost.

Documentation to Request from Suppliers

Depending on the product group, requested documentation may include:

- Market authorization information.
- Catalog.
- Technical documentation.
- Instructions for use.
- Model list.
- Test menu.
- Reagent list.
- Calibrators.
- Control materials.
- Infrastructure requirements.
- Water requirements.
- Electrical requirements.
- LIS connectivity plan.
- Installation plan.
- Training plan.
- Maintenance plan.
- Warranty service provider information.
- Spare parts list.
- Software update policy.
- Post-warranty service price list.
- Estimated reagent costs.
- Backup equipment arrangements.

In Vietnam, management of medical devices, including in vitro diagnostic medical devices, should be reviewed against current requirements governing market authorization, classification, importation, trading, and use. Decree No. 98/2021/NĐ-CP is a foundational regulation on medical device management and has been amended and supplemented by subsequent regulations, including Decree No. 04/2025/NĐ-CP. Circular No. 24/2026/TT-BYT, effective July 1, 2026, also provides additional provisions on determining risk levels and management measures for products and goods classified as medical devices.

Businesses and healthcare facilities should review the regulations, forms, and guidance in effect at the time of implementation rather than relying on documentation from a previous project as their sole template.

When Should a Laboratory Prioritize Automation?

Automation may be appropriate when:

- Sample volume is high and relatively stable.
- Many tasks are repetitive.
- A high proportion of specimens arrive during peak hours.
- The test menu is concentrated.
- Specimen flow is standardized.
- Adequate space is available.
- The LIS is stable.
- Technical staff can support the system.
- Reagent supply is reliable.
- Investment costs are proportionate to utilization.

Automation may not yet be necessary when:

- Sample volume is low.
- The test menu is highly dispersed.
- Many specimens require exception handling.
- Space is limited.
- Infrastructure is unstable.
- Current workflows are not standardized.
- System administration staff are unavailable.
- Maintenance costs exceed expected utilization.

Automation should be viewed as a way of reorganizing workflow, not simply as the purchase of additional conveyors or robots.

Explore Laboratory and In Vitro Diagnostic Technologies at PHARMEDI & HEALTHCARE VIETNAM 2026

A well-designed laboratory does not depend on a single high-throughput analyzer. Stable performance requires coordination across specimen collection and preparation, analytical systems, reagents, quality control, LIS connectivity, maintenance, supporting infrastructure, and post-analytical workflows.

For hospitals, laboratories, distributors, and healthcare businesses evaluating new testing solutions, directly comparing technologies can provide a clearer understanding of how different systems are configured and how they may fit into existing laboratory workflows.

At PHARMEDI & HEALTHCARE VIETNAM 2026, exhibition categories related to laboratory and testing equipment, in vitro diagnostic technologies, diagnostic solutions, medical devices, digital health, and healthcare technologies provide opportunities to explore solutions across different stages of laboratory operations.

For organizations reviewing laboratory equipment or planning future investments, visiting PHARMEDI VIETNAM 2026 can provide an opportunity to discuss practical considerations directly with manufacturers, distributors, and technology providers:

- Which test menus and specimen types are supported by each platform?
- What level of throughput is achievable under actual operating conditions?
- How are emergency specimens, reruns, dilutions, and abnormal samples handled?
- Which reagents, calibrators, quality control materials, and consumables are required?
- What are the reagent shelf-life, open-vial stability, and on-board stability conditions?
- How can analyzers connect with LIS, HIS, or other laboratory data systems?
- Which software modules and connectivity licenses are included in the proposed configuration?
- What pre-analytical or automation options are available as sample volume increases?
- What electrical, water, environmental, and biosafety requirements should be prepared?
- How are preventive maintenance, calibration, spare parts, and technical support organized?
- What backup options are available if the primary analyzer is temporarily unavailable?
- How can the system be expanded when the laboratory increases its test menu or sample volume?

These discussions do not replace the facility's technical evaluation, quality management procedures, or regulatory requirements. Instead, they can help laboratories compare the complete operating ecosystem behind different IVD solutions, from analyzers and reagents to automation, data connectivity, and long-term technical support.

In this way, PHARMEDI VIETNAM 2026 provides additional opportunities for healthcare facilities and businesses to explore laboratory and IVD technologies, engage with suppliers, and better understand how different solutions may support laboratory workflow, scalability, and long-term operations before developing specific procurement or investment plans.

Dates: September 22–24, 2026

Venue: Saigon Exhibition and Convention Center (SECC), Ho Chi Minh City

Exhibitor Registration: https://pharmed.vn/exhibitor/application-form

Visitor Registration: https://ers-vn.informa-info.com/pha2026?cid=FB

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Contact

Booth Booking: [email protected] (Thanh Thuý)

Media Support: [email protected] (Anita Pham)

Visitor Support: [email protected] (Ciel Le)

This article is provided for informational purposes only. The selection, implementation, and use of laboratory equipment should be based on the facility's scope of clinical or laboratory practice, quality management procedures, manufacturer instructions, and current regulations. Test results should be evaluated by authorized healthcare professionals and should not be used for self-diagnosis or self-treatment.