Rapid Deploy: A Preconfigured, CLIA & ISO 15189 Compliant COVID-19 LIMS for SARS-CoV-2 Diagnostic Testing & Research Labs

Out of the Box: CDC/CSTE/FEMA eReporting of COVID-19 Test Results

Deploy in Less than a Week: COVID-19 LIMS Preconfigured with FDA Approved COVID-19 Tests, Reports and Workflows

Free eBook: A Comprehensive Guide to Regulatory Compliance for COVID-19 Testing Labs

Deploy in Less than a Week: Preconfigured COVID-19 Testing & Research Workflows Using CloudLIMS, an in the Cloud COVID-19 LIMS

Clinical testing and research laboratories across the globe are working on a war-footing to test and find a vaccine for the novel coronavirus disease (COVID-19). CloudLIMS has already helped multiple labs get up and running in less than a week using FDA approved, preconfigured workflows. Some of the major challenges faced by COVID-19 testing laboratories are as follows:

  • Rapid configuration of FDA approved COVID-19 test workflows.
  • Development standardization and validation of new methods for testing COVID-19.
  • Reporting test results as per FDA and CDC guidelines.
  • Following international regulatory guidelines such as CLIA ISO 15189:2012 and HIPAA.

A Schematic Representation of a Preconfigured COVID-19 Diagnostic Testing Laboratory Workflow

COVID-19 LIMS Software for Coronavirus Diagnostic Testing and Research Labs

CloudLIMS is a preconfigured, scalable, in the cloud COVID-19 LIMS for COVID-19 research and diagnostic testing laboratories. CloudLIMS is preconfigured with COVID-19 specific tests, such as RT-PCR, serological tests for the detection of IgG/IgM antibodies, Enzyme-linked Immunosorbent Assay (ELISA), neutralization test, and Rapid Diagnostic Test (RDT). Furthermore, it is configured with COVID-19 and other infectious disease workflows and reporting templates for quick reporting of test results. CloudLIMS can be easily configured to support new test methods, assays, and reporting requirements, including those of FDA and CDC, avoiding time-consuming customization. The preconfiguration helps minimize onboarding time and enables laboratories to go-live within just a couple of days. CloudLIMS can be accessed anytime, anywhere, is easy to deploy, and enables COVID-19 laboratories to quickly automate without the need to invest in IT infrastructure or personnel.

CloudLIMS customers have realized benefits in the following ways:
  • Meet regulatory guidelines and standards such as CLIA HIPAA GCP EU GDPR 21 CFR Part 11 and ISO 15189:2012.
  • Generate custom test reports to comply with the FDA and CDC reporting guidelines.
  • A self-serve physician portal to enable physicians to enter patient data and associate patient records with samples place diagnostic test requests track request status in real-time download test reports and invoices.
  • Maintain a read-only audit trail to automatically record laboratory activities with a date and time stamp.
  • Customizable forms to manage COVID-19 specimens patient data diagnostic tests and their results clinical studies kits freezer inventory and specimen shipment.
  • Safeguard PHI (Protected Health Information) of patients by assigning role-based PHI access to authorized personnel only.

Seamlessly Follow CLIA, ISO 15189, and HIPAA Guidelines

Anonymize PHI of patients to protect sensitive data from unauthorized access by assigning role-based access to authorized personnel only.

Manage training and competency records of laboratory personnel and regularly monitor their performance for quality assurance. This helps laboratory managers to assign tasks only to the person with appropriate training, competency, and experience to perform the tasks efficiently.

Manage records of analytical instruments, schedule instrument calibration and perform preventive maintenance as defined by the instrument manufacturer or laboratory’s internal practices. CloudLIMS helps you maintain calibration and maintenance results, and records of functional checks performed before use.

Supports management of documents such as Standard Operating Procedures (SOPs), validated standard test methods, drawings, manuals, and enables their access to authorized personnel.

Advantages of CloudLIMS - A Complete COVID-19 LIMS Software

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Manage Patients/Subjects

Seamlessly manage data of the Person Under Investigation (PUI), including their demographic details, informed consent, symptoms, clinical course, travel history, past medical history, and pre-existing medical conditions.

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Manage COVID-19 Specimens

Assign unique system-generated or user-defined IDs to specimens, manage specimen data, generate barcodes for specimens, scan barcodes to quickly import specimens in CloudLIMS, and print labels. You can import specimens or aliquots from a file, maintain a specimen Chain of Custody (CoC), and track each specimen throughout its life cycle.

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Manage COVID-19 Diagnostic Tests & Test Results

Manage various preconfigured tests such as RT-PCR and serological tests, maintain test CoC, configure flagging sets to automatically flag COVID-19 positive results. You can include positive, negative and inconclusive test results and patient demographic details while reporting reports to comply with the FDA and CDC reporting guidelines. Longitudinal studies of the patients, with test results of a period of time, can also be maintained.

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Digital Issuance of Test Reports

Deliver COVID-19 test reports to patients at their registered email addresses and mobile numbers. As soon as a patient's test report is validated and released, it is added to the patient's record. You can then directly email the test report or push it to a mobile app as well as the physician on file, reducing turnaround time and enabling quick decision making for treatment, quarantine and isolation, curbing further spread in the community.

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Manage COVID-19 Diagnostic Kits

Manage preconfigured kits, such as IgM/IgG antibody detection kits, SARS-CoV-2 Fluorescent PCR Kits, Personal Protective Equipment (PPE) kits along with their initial and current quantity. You can configure your laboratory kits as well. You can set reminders to receive alerts if the current number of kits is less than a specified quantity, ensuring timely ordering of kits.

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Manage Workflows & Enforce SOPs

Configure workflow templates and streamline your laboratory workflows with ease. The personnel assigned to the first task in the workflow can commence it. After completing a step, it can be marked as complete so that the next step opens for the next person. The step can only be performed if the steps before it in the workflow (if any) are complete, enforcing the laboratory staff to follow established SOPs.

HIPAA-Compliant Patient Portal

CloudLIMS’s all-in-one HIPAA-compliant, secure, cloud-based patient portal enables COVID-19 diagnostic laboratories to offer direct-to-patient services. The seamless communication with patients allows for better customer service and minimizes turnaround time.

Workplace Testing

Employers are hard-pressed to provide workplace COVID-19 testing for their employees while ensuring a safe working environment, complying fully and minimizing risks. Most are cognizant of the fact that any asymptomatic employee can be a carrier and easily infect the entire workforce. This could easily translate to massive man-hour losses for the company. Most importantly, the health and safety of the staff and their families would be greatly compromised.

With this realization, employers must conduct accurate & frequent testing to ensure the safety of all their employees.

Mobile Testing

As we adapt to “living with the novel coronavirus,” communities, public health organizations, neighborhoods, corporates, and similar institutions need to take COVID-19 safety precautions and accelerate testing. Mobile or pop-up COVID-19 diagnostic laboratories facilitate field-based testing and bring COVID-19 testing to all areas, no matter where people live or work. Mobile testing laboratories can be quickly deployed in hot spots, underserved communities, and workplaces. Widespread and easily accessible testing is crucial to meet the testing demand and prevent the spread of COVID-19 in the community. Consequently, public and private organizations are looking for cost-effective yet reliable methods for onsite testing that save time and space.

Schools & Universities Set Up

After a long period of remote classes, learning institutions are gearing up for physical reopening. As much as this may sound exciting, it is scary at the same time. The reason being that COVID-19 is still with us at large. If anything, new infectious variants are emerging with time. How can schools and universities guarantee the safety of their students and staff as they resume in-person classes?

Those in congregate settings such as learning institutions are at an increased risk of contracting COVID-19. According to the Centers for Disease Control and Prevention (CDC), the early detection and isolation of infected individuals in such institutions will help to reduce the spread of SARS-CoV-2. Therefore, administrators at such institutions need to take extra measures to ensure the safety of their staff and students as they resume in-person classes. Widespread testing is crucial to identify infected students and isolate them to curb the spread of the virus. Other measures that learning institutions need to implement include hand washing, social distancing, using face masks, ensuring adequate ventilation, and vaccinating staff and students.

Clinics & Physician Office Labs

COVID-19 testing is an effective strategy to combat the global pandemic that has so far resulted in millions of deaths globally. While most testing is usually carried out in third-party labs, clinics and physician offices provide an opportunity for onsite testing that increases the efficiency of testing and reduces associated costs at the same time.

Physician office labs (POLs) improve patient care because they facilitate early diagnosis and consequently early initiation of treatment. When physicians have an in-house laboratory, they can test their patients immediately whenever they deem it necessary. This also means that they can access test results sooner and embark on a clinical course without any delay. Such a process minimizes sample loss or mix-ups that may occur during the transportation of samples from physician offices to an offsite testing laboratory.

Instrument and Software Integration

COVID-19 diagnostic testing laboratories receive hundreds of COVID-19 specimens on a day-to-day basis. One of the most common and reliable tests used for testing COVID-19 specimens is RT-PCR, a real-time reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of RNA of SARS-CoV-2. DNA sequencing is done for the confirmation of test results if required. Manual transfer of analytical data of thousands of specimens from RT-PCR instruments and other analytical instruments to a LIMS is error-prone and reduces laboratory efficiency. For minimizing the test turnaround time, it is important to automate the data transfer process. CloudLIMS can be seamlessly integrated with analytical instruments and software for bi-directional data transfer, thereby reducing turnaround time and eliminating chances of transcription errors.

How Does CloudLIMS Support Instrument & Software Integrations for COVID-19 Testing Labs?

CloudLIMS supports integration with analytical instruments and software through the following methods:

  • Instrument Integration:CSV/XLS is a standard output file type generated by most analytical instruments. The CSV file mapping enables data to be imported from multiple instruments into a LIMS. CloudLIMS periodically reads instrument generated CSV files and maps the headers present in the files with the correct fields in CloudLIMS thereby transferring the analytical data to CloudLIMS seamlessly. CloudLIMS is reconfigured to seamlessly integrate with COVID-19 testing instruments such as RT-PCR for uni-directional data transfer.
  • Software Integration:CloudLIMS’ Rest API can be configured to support integration with third-party software such as EMR EHR LIS Patient Registries etc. CloudLIMS results can be pre-configured and uploaded to the electronic reporting system of CDC/CSTE FEMA and other e-reporting tools thereby utomating reporting of test results. Furthermore it can be integrated with medical or clinical billing software to effectively manage revenue cycles and minimize billing errors enhancing customer experience. thereby transferring the analytical data to CloudLIMS seamlessly. CloudLIMS is preconfigured to seamlessly integrate with COVID-19 testing instruments such as RT-PCR for uni-directional data transfer.

Follow Regulatory Guidelines and Standards

CloudLIMS' COVID-19 LIMS Software Functionality

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Manage Studies

Manage various COVID-19 related studies, such as population-based cohort studies, viral genome mutation studies, and molecular epidemiological studies. You can associate each study with specimens, patients, and generate custom study reports. You can batch import study records from a file, saving time and eliminating chances of manual errors.

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Manage Packaging and Shipment of COVID-19 Specimens

Assign a unique ID to each incoming and outgoing shipment, associate each shipment with COVID-19 specimens, and track all shipments right from the origin to the destination to avoid misplacing biohazardous specimens.

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Locate Stored Specimens

Create hierarchical storage units to mirror your storage inventory, assign COVID-19 specimens to storage units automatically based on barcodes, and quickly locate stored specimens whenever required for quality control checks or for shipment to research laboratories.

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Inventory Management

Manage laboratory inventory such as reagents, laboratory coats, gloves, surgical masks, and import inventory records from a file. Furthermore, you can associate each inventory item with specimens, patient ID, diagnostic tests, and edit multiple inventory records simultaneously.

What Our Customers Say About Us

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Webinars

How Laboratories can Accelerate COVID-19 Testing & Issue Results Directly to Healthcare Wallets

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eBook

Free eBook: A Comprehensive Guide to Regulatory Compliance for COVID-19 Testing Laboratories

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Talks

Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Lab? LIMS for Automation and Data Management

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Publications

Current and Upcoming SARS-CoV-2 Diagnostic Tests: Everything You Need to Know

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