HRDR Frequently Asked Questions

Topics

  1. PERFORMANCE & ACCURACY
  2. PLATFORM
  3. FUNCTIONALITY
  4. CALIBRATION
  5. TEST RESULTS & SECURITY
  6. HOW WE WORK – OUR COLLABORATIVE PROCESS
  7. REGULATORY

PERFORMANCE & ACCURACY

1) How is the HRDR different than other readers in the marketplace?

We believe it is of higher sensitivity, smallest size and most accurate making it the best performing reader in the market. We also provide a complete reader solution, whether you need a customized reader, portable or desktop, for your lab or for your customers, CLOUD services for data capture and transfer as well as integration with your existing database or EHR system. Our collaborative and customized solutions and process ensures that your specifications are met.

2) Are there different versions of the HRDR?

Yes. HRDR-200 for chromatographic tests. HRDR-300 for fluorescent tests. HRDR-400, a dual reader, for chromatographic and fluorescent tests. HSTA, a dedicated reader for substance abuse tests.

3) What is the HRDR advantage over software only readers? Does the hardware snap on attachment compromise ease of use and price?

Software only readers are not reliable: a light bulb in your office goes dim and you get a different test result. Our hardware snap on attachment ensures high accuracy under any conditions and is lightweight and easy to use. Performance is of utmost importance and at the same time the HRDR is competitively priced.

4) Is the HRDR quantitative? What sensitivity and specificity?

Yes. The reader has trans-visual sensitivity (what is not visible) and a CV of less than 1%, making it the best performing reader in the market.

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PLATFORM

1) Does the HRDR operate on any platform?

Yes. The standard version operates on an Android Smartphone. But, yes, we can customize to other operating systems and platforms.

2) Can we use any phone? What about phone obsolescence?

We look for certain features in Smartphones and if they meet requirements, we can use other phones. Phone obsolescence does not impact the readers in the field in any way. Software updates will continue supporting readers in the field even if new versions might be developed for newer phones. For new production, handling of obsolescence and replacement of any part is a stock in trade for manufacturing companies with well-established change management processes.

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FUNCTIONALITY

1) What level of skill is required to use the HRDR?

Using the reader and interpreting results requires minimal skill and training. It is as easy as operating a cellphone.

2) Is the HRDR universal to different RDT shapes?

Yes. We can accommodate all test shapes and formats. And you can use tests of different formats with the same reader without any difficulty.

3) Can you read RDTs with multiple lines? Any limit on lines?

Yes. We can read multiple lines. No limit on lines. We can also read dots, squares, you name it.

4) Is there a fluorescent version of the HRDR?

Yes. We have developed 3 versions, one chromatographic (HRDR-200), one fluorescent (HRDR-300), and one with both capabilities (HRDR-400).

5) How many tests can you conduct on the HRDR per charge?

Over 500 tests may be conducted per charge.

6) Can you customize the GUI and CLOUD functionality? Languages?

Yes. We can change the GUI and CLOUD interface per your specifications and also to different languages.

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CALIBRATION & NEW TEST TYPES

1) How do you calibrate the reader to devices from different lots?

The vendor will upload lot parameters to the Cellmic CLOUD server and users will be prompted to download directly to the reader. No dealing with expensive lot memory cards to mail and lose. Our Test Developer Software is a tool specifically for vendors and test manufacturers, to help development and manufacture of lateral flow tests. It operates in conjunction with our readers enabling quality control during test development as well as reader calibration.

2) How do we adapt and calibrate your reader to our tests?

It’s easy. You send us a set of tests, we perform the calibration for you, and we deliver readers ready for use. Or, you perform your own calibration with our Test Developer Software.

3) How do we distribute files for new test types to our end users?

Simply upload them to the CLOUD server for end user access.

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TEST RESULTS & SECURITY

1) How are test results stored?

Test results may be stored securely on the phone, uploaded to a secure CLOUD server, e mailed, and printed via Wi-Fi or Bluetooth. Cellmic’s secure CLOUD services, hosted by HIPAA compliant TRUEVAULT data center and compatible with HL7 standards, enables wireless upload of test results from our readers. The service features data storage, processing and analytics, and access to a real-time map of the geographic distribution of test results by disease and demographic data.

2) Can you integrate test data into existing databases and EHR Systems?

Yes. Test results may be exported from the phone to a PC as well as integrated with your existing database, Laboratory Information Systems, Healthcare Information Systems or Electronic Health Records. We have a portfolio of interface solutions and are also have access to our partner SCC Soft Computer, Inc., one of the largest suppliers of Laboratory Information Management Systems, and their vast integration capabilities.

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HOW WE WORK – OUR COLLABORATIVE PROCESS

1) Describe your collaborative process?

It is fast and easy. You send us information about your test and a sample and volume requirements and we’ll send you a quote for the adaptation cost, if any, and unit cost. After the initial order we typically go with you through preliminary testing, verification testing, and validation testing leading to the supply agreement; however, we are flexible and always aim to meet your requirements which are usually different if you are a test manufacturer, or a distributor, or an NGO, or a university, or a healthcare provider.

2) What is your delivery timeline?

4 to 6 weeks ARO

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REGULATORY

1) Do you have the CE Mark?

Yes.

2) How about FDA approval for the US?

In the US the HRDR is currently available for Research Use Only. For clinical diagnostic use we will need to collaborate and apply to the FDA for the approval of the “system” comprised of your test and our reader- this is the FDA rule for any reader/test combination. Note that the HRDR is already registered with the FDA as a Class I device meeting ISO 13485 requirements and is ready to start performance testing with your devices for a speedy 510 (k) submission.

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