FAQs

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. Are your tests CE marked? >>
  2. Are the OnSite Malaria Ag Rapid Tests WHO approved? >>
  3. Can I use the buffer supplied in one OnSite Rapid Test Kit to run a different OnSite Rapid Test? >>
  4. Should a faint test line be interpreted as positive or negative? >>
  5. What do I do if a test produces an invalid result? >>
  6. Can additional accessories be provided in a test kit? >>
  7. Do you provide customized packaging and/or OEM options? >>
1

Q: Are your tests CE marked?

A: Most of CTK's diagnostic test kits are CE marked indicating that they meet the requirements of the relevant product directives. Test kits that carry a CE mark show the symbol next to the test kit name in our online product listings and in our Diagnostics Catalog available for download in our support section.

2

Q: Are the OnSite Malaria Ag Rapid Tests WHO approved?

A: All three OnSite Malaria Ag Rapid Tests have been evaluated as part of the WHO Malaria RDT Testing Programme and meet all of the performance criteria outlined by WHO that guide the recommendations for procurement of malaria RDTs. These criteria include A) for the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples should be at least 75% at 200 parasites/μL, B) for the detection of Plasmodium vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites/μL, C) the false positive rate should be less than 10%, and D) the invalid rate should be less than 5%. Only products meeting the performance criteria outlined in A, B, C and D are recommended for procurement. You can view the OnSite Malaria Ag Rapid Test performance in the Results of WHO product testing of malaria RDTs: Round 5 report.

3

Q: Can I use the buffer supplied in one OnSite Rapid Test Kit to run a different OnSite Rapid Test?

A: No, the buffer supplied with each OnSite Rapid Test Kit is intended for use only with the kit in which it is supplied. The composition of each buffer is optimized for that particular test, so buffers are not interchangeable between kits. To ensure that you are using the correct buffer, check that the test name on the buffer label matches the test name on the pouch.

4

Q: Should a faint test line be interpreted as positive or negative?

A: Any color development on the test line in combination with development of the control line indicates a positive or reactive test result. The intensity of the test line does not correlate with the target concentration in the specimen. Specimens with reactive results should be confirmed with alternative testing methods and clinical findings before a positive determination is made. Consult the instructions for use supplied with each kit for a detailed explanation on the interpretation of assay results.

5

Q: What do I do if a test produces an invalid result?

A: Invalid test results are most commonly caused by insufficient sample volume or procedural error. If the control line does not develop, review the entire procedure in the instructions for use provided with the kit and repeat the assay with a new test device. If invalid results occur repeatedly, please note the lot number printed on the back of the pouch and immediately report it to <http://www.privatedaddy.com?q=V0JkNGBlcwlUDAcubnJeLzp2S25WUDA-3D_19>.

6

Q: Can additional accessories be provided in a test kit?

A: As the developer and manufacturer of our test kits, we have the ability to customize test components to meet various requirements when necessary. To discuss these options, please contact our sales department.

7

Q: Do you provide customized packaging and/or OEM options?

A: In addition to offering a broad portfolio of branded products, CTK can provide private label manufacturing (OEM). From customized labeling requirements to unique brand specifications, our products can be customized to meet your unique packaging needs. Our team is experienced at handling the logistics involved in providing customized packaging and the OEM manufacturing process. Please contact our sales department to discuss these options.