FAQs

Frequently asked questions

Answers to our most frequently asked questions are provided below. If you cannot find the answer you are looking for, please contact us.

  1. What is the difference between an ELISA and a Rapid test? >>
  2. Why would the intensity of the color on a rapid test vary from patient to patient? >>
  3. Does the Rapid Test Reader need calibration? >>
  4. Can your rapid test external controls be used for training purposes? >>
  5. What thermocyclers are compatible with your PCR product range? >>
  6. My sales team needs training on your latest technologies. How can they get the required training? >>
  7. Many companies have ISO 13485:2003 or ISO 13485:2003, while CTK has ISO 13485:2016. What is the difference? >>
  8. How do I request distributor information in my country? >>
  9. Do you provide translations or different languages for your products? >>
  10. Is Rapid Test a confirmatory test? >>
  11. What does it mean that your IVD tests are intended for professional use only? >>
  12. Why is specimen flow on a rapid test slow or isn’t happening? >>
  13. Are CTK’s instruments considered closed systems? >>
  14. What causes a false positive ELISA test result? >>
  15. What is your ELISA kit validation process? >>
  16. How many samples can I test on one CTK ELISA? >>
  17. My ELISA kit was left out at room temperature for several days. Is it still good? >>
  18. Can I use your Rapid Test Reader with tests from other companies? >>
  19. I may have overloaded the cassette with too much specimen, does this invalidate the test? >>
  20. My test has expired, but I used it and got a positive patient result. Should I consider this positive? >>
  21. I have a question that isn’t in the FAQs, who can I contact? >>
1

Q: What is the difference between an ELISA and a Rapid test?

A: An ELISA test is an enzyme linked immunosorbent assay that is in general more sensitive than rapid tests. ELISA tests require additional equipment such as an ELISA reader and pipettes. A rapid test is designed to be a simple, straightforward diagnostic technique that can be performed by minimally skilled personnel without additional laboratory equipment.

2

Q: Why would the intensity of the color on a rapid test vary from patient to patient?

A: Line intensity can vary with different parameters, such as specimen type, composition, storage conditions, and many other factors. Line intensity is not directly proportional to the number of detecting antibodies or antigen present in the sample. The formation of a line, regardless of intensity, indicates a positive result.

3

Q: Does the Rapid Test Reader need calibration?

A: CTK’s Rapid Test Reader does not require calibration.

4

Q: Can your rapid test external controls be used for training purposes?

A: CTK’s external controls are designed to be used to verify that our rapid tests are functioning correctly. They can be used to train laboratory staff to recognize positive and negative results.

5

Q: What thermocyclers are compatible with your PCR product range?

A: CTK’s PCR product range is compatible with top-scanning thermocyclers that support 0.2 mL tubes (21 mm, high profile) and 0.1 mL tubes (15.8 mm, low profile). In addition, users can also resuspend the ready-to-use PCR mix and transfer the reaction to their tube of choice.

6

Q: My sales team needs training on your latest technologies. How can they get the required training?

A: CTK is happy to provide technical and sales training across all our product ranges. We have a library of training resources including videos on our website: https://ctkbiotech.com/support/training-resources/.  CTK staff can also set up customized training either via webinar or in person.

7

Q: Many companies have ISO 13485:2003 or ISO 13485:2003, while CTK has ISO 13485:2016. What is the difference?

A: ISO 13485:2016 is a significant and major revision of the quality management system standard from previous revisions. CTK is committed to staying up to date with the latest quality standards and regulations. Some advantages of a company certifying to 2016 are:

  1. It improves the likelihood that a medical device company will meet customer requirements
  2. The company focuses on risk management and risk-based decision-making processes
  3. The quality management system is equipped to meet FDA, EU Regulations and othe Regulatory Compliance

8

Q: How do I request distributor information in my country?

A: Please contact CTK’s sales team directly here: https://ctkbiotech.com/distribution/distributor-opportunities/

9

Q: Do you provide translations or different languages for your products?

A: Yes! We offer translations and different languages for all of our products. Please contact us if you need our products in a different language.

10

Q: Is Rapid Test a confirmatory test?

A: A Rapid test is a diagnostic test that is meant to be used as an aid in diagnosis. Any use or interpretation of these results must also rely on other clinical findings and alternative test methods such as an ELISA or PCR test should be used to confirm positive rapid test results.

11

Q: What does it mean that your IVD tests are intended for professional use only?

A: Only professionals with required training are to perform these tests, ranging from rapid tests, ELISA, PCR and FIA.

12

Q: Why is specimen flow on a rapid test slow or isn’t happening?

A: This could be due to a variety of reasons such as: no sample diluent, not enough sample diluent, not enough specimen, specimen that is too thick (increased lipids, hemolysis, etc.), and a number of other conditions that could affect the specimen.

13

Q: Are CTK’s instruments considered closed systems?

A: Some of our instruments, such as our Rapid Test Reader, are closed systems. However, our ELISA Reader and Washer are open systems and can be used with other products.

14

Q: What causes a false positive ELISA test result?

A: Antibodies that cross-react with an antigen in the sample (different than the target antigen), as well as non-specific protein interactions may cause false results. All ELISA kits are subjected to cross-reactivity testing with common interfering substances. Further information on the substances tested for each kit can be found in the product insert.

15

Q: What is your ELISA kit validation process?

A: At CTK we prioritize creating quality products. Our ELISA validation process is very extensive and includes: Control Values based on Kit Components, Analytical Sensitivity, Linearity, Recovery, Inter-Assay and Intra-Assay Precision, Cross Reactivity, Accuracy, Accelerated and Real Time Stability, In-Use Stability, Hook Effect, Real-Time Stability, and Shipping Simulation. This validation procedure ensures that each kit performs up to end user requirements.

16

Q: How many samples can I test on one CTK ELISA?

A: Up to 82 samples can be run on any one 96-microwell ELISA plate, since wells on each plate must be allocated for provided calibrators as well as the IA control for accuracy.

17

Q: My ELISA kit was left out at room temperature for several days. Is it still good?

A: It is best to store all ELISA kits at 2-8ºC, as extended time at room temperature can lead to expedited degradation of kit components. We do not advise using kits that have fallen outside of the recommended storage conditions.

18

Q: Can I use your Rapid Test Reader with tests from other companies?

A: Our rapid test reader is designed to only perform with CTK’s OnSite and Aria branded rapid tests. We don’t guarantee results on any other manufactured tests.

19

Q: I may have overloaded the cassette with too much specimen, does this invalidate the test?

A: If the cassette has been overloaded, it means either too much specimen or too much buffer was used. In either case the performance characteristics of the test could be different because it is outside of the recommended use. The test should be repeated, ensuring that the cassette is loaded correctly.

20

Q: My test has expired, but I used it and got a positive patient result. Should I consider this positive?

A: If the tests fall outside of the recommended usage date, we cannot guarantee the performance of the tests according to our normal specifications. The assay should be repeated with an unexpired test and all positive results should be verified with another confirmatory method.

21

Q: I have a question that isn’t in the FAQs, who can I contact?

A: Feel free to reach out to us on the “Contact” tab on our website. A staff member will address your question as soon as possible.