Frequently Asked Questions (FAQs)

General
Questions

Purchase-Related
Questions

Mohs Surgery
Questions

General Questions

  1. What makes your polyHRP product better than others?
  2. Do your tests work with both FFPE and frozen tissues?
  3. What kind of slides should I use?
  4. How should the individual reagents be stored after I receive shipment?
  5. What is the shelf life of the products?
  6. The kit is labeled as ready-to-use, why do I need to dilute the DAB substrate and buffer?
  7. Do I need to use the blocker provided in the kit?
  8. Do you use monoclonal antibodies in your kits?
  9. The Instruction for Use (IFU) states to gently shake the antibody bottle before using, can I vortex the bottle instead?
  10. Can I dilute the pHRP antibody to stretch the use of the kit?
  11. Do I need to dilute the buffer that ships with the kit?
  12. Can I use my own buffer?
  13. What fixative should I use?
  14. Can I use my own DAB substrate?
  15. Can I use another substrate that is compatible with HRP?
  16. Do you have any multiplexed kits? Or can I multiplex with your products?
  17. Do you have any alkaline phosphatase (AP) products?
  18. Do you have pHRP labeled secondary antibodies?
  19. Do you offer custom conjugation to a customer’s antibody?
  20. Can your polyHRP products be used for applications other than IHC?
  21. Are any of your kits used for cytology (ICC)?

Purchasing Related Questions

  1. How do I buy your products?
  2. Can Novodiax ship to multiple shipping locations?
  3. How much are your kits?
  4. How can I get a quote?
  5. Can Novodiax provide custom bulk packaging of your existing products?
  6. How much do your custom services cost?
  7. How do the kits ship?

Mohs Related Questions

  1. How many tissues can I process with your kits?
  2. Is it possible to use the Mart-1 stain with frozen tissues?
  3. Why would I need a CK5 for basal and squamous, I already run H&E tests for that?
  4. How can I use your tests to differentiate exocrine glands from carcinoma cells in BCC/SCC?
  5. Are your test kits subject to reimbursement?
  6. Do you have a kit that will help differentiate inflammation from carcinoma or melanoma cells?
  7. Do you have a kit that will help me evaluate neural invasion?
  8. Running your test is really simple, but I may need some help interpreting slides. Can you help?
  9. Can mobile Mohs technicians use your kits?

Answers to FAQs

General Questions

  1. What makes your polyHRP product better than others?
    Our unique and primary method allows us to more efficiently label antibodies with our poly HRP complex while maintaining the integrity of the binding epitope. The resulting ihcDirect® and ihcPrime® products retain their binding affinities for their antigens while carrying more HRP for reacting with the DAB substrate. Those two features result in faster test results with outstanding sensitivity.
  2. Do your tests work with both FFPE and frozen tissues?
    All of our ihcDirect (for IVD use) and our ihcPrime (RUO) are optimized to work with frozen tissues, and most of those kits also work with FFPE samples. If a kit does not work with FFPE, it will be documented in the product instructions for use.
  3. What kind of slides should I use?
    The most important requirement of the slides is that they must be positively charged to ensure the tissue will remain intact on the slide when the reagents are added. The physical dimensions are independent of our protocol.
  4. How should the individual reagents be stored after I receive shipment?
    The pHRP-Ab, blocker, DAB substrate, and diluent should be stored as instructed on the product label and instructions for use. As instructed in the IFU, take the reagents out of the refrigerator approximately 30 minutes prior using, and roll the bottles in your hands to warm the reagents if they feel cool.
  5. What is the shelf life of the products?
    The shelf life of the product is provided on the reagent vial and kit labels and may vary with product. Novodiax policy is to not ship products with less than 3 months of shelf life remaining.
  6. The kit is labeled as ready-to-use, why do I need to dilute the DAB substrate and buffer?
    The DAB substrate will last approximately 8 hours at room temperature after the diluent has been added. For that reason, we cannot package the DAB substrate as ready to use.
  7. Do I need to use the blocker provided in the kit?
    The verification and validation data generated for all our kits include using the blocker in the protocol. So, we cannot guarantee results if the blocker is not used. However, we appreciate that not all tissues react equally with each antibody, and some tissues may have significantly lower background signal without the use of a blocker. Furthermore, removing the blocker step in the protocol can further reduce time to results. Therefore, we cannot guarantee results without the blocker, and customers are encouraged to validate their own results if doing so.
  8. Do you use monoclonal antibodies in your kits?
    All of our ihcDirect and ihcPrime kits use monoclonal antibodies. The Q-stain secondary antibodies are all poly-clonal antibodies.
  9. The Instruction for Use (IFU) states to gently shake the antibody bottle before using, can I vortex the bottle instead?
    The pHRP complex can aggregate over time, which is why we recommend gently shaking the bottle in your hand before using. Using a tube vortex can compromise the integrity of the pHRP complex and cause poor results.
  10. Can I dilute the pHRP antibody to stretch the use of the kit?
    All ihcDirect and ihcPrime kits include a ready-to-use antibody formulation that is optimized for use as IHC tests with frozen and FFPE tissues. We do not recommend diluting the antibody further and doing so will most likely give sub-optimal results.
  11. Do I need to dilute the wash buffer that ships with the kit?
    The buffer ships in a 10X concentration and should be diluted 1:10 with reagent grade water before use.
  12. Can I use my own buffer?
     We do provide our buffer formulation in our IFU for customers who prefer to make up their own buffer solution. However, we cannot guarantee results when using a buffer that deviates from the Novodiax buffer formulation.
  13. What fixative should I use?
    The recommended fixative for the antibody reagent is provided in the product instructions for use. Our ihcDirect and ihcPrime products are validated using the fixative recommended. The user must validate use of other fixatives.
  14. Can I use my own DAB substrate?
    The pHRP antibody has been optimized to be used with Novodiax reagents.  The user must validate use of non Novodiax recommended reagents.
  15. Can I use another substrate that is compatible with HRP?
    Users must validate use of another substrate. We cannot guarantee results when using another reagent that is not from Novodiax.
  16. Do you have any multiplexed kits? Or can I multiplex with your products?
    We do not currently offer kits that are optimized for multiplexing. However, we have presented posters demonstrating feasibility and methods to multiplex with our products. Our ihcDirect kits are optimized to work with the DAB substrate, and we cannot guarantee results if used with another substrate, and customers are encouraged to validate their own results if doing so.
  17. Do you have any alkaline phosphatase (AP) products?
    AP reaction kinetics are much slower than HRP, which makes it more challenging as an intraoperative test. Therefore, we do not offer AP products in our catalog. However, we do offer custom services to conjugate a poly-AP complex to your antibody. To find out more, please inquire here.
  18. Do you have pHRP labeled secondary antibodies?
    Yes, our Q-Stain products are for Research Use Only, and can be found in our web catalog.
  19. Do you offer custom conjugation to a customer’s antibody?
    Yes! Please visit our custom services page here.
  20. Can your polyHRP products be used for applications other than IHC?
    Our products are typically optimized for use in IHC, ICC, or ELISA applications as described in the instructions for use. We cannot guarantee results when using our products for other immunoassays (eg western blot, flow cytometry, etc.).
  21. Are any of your kits used for cytology (ICC)?
    Our ihcDirect products are verified and validated for use with IHC tests. However, we have shown in posters how our ihcPrime (RUO) products have been used in duplexed and triplexed assays for melanoma, basal cell carcinoma, and breast cancer tests.

Purchasing Related Questions

  1. How do I buy your products?
    You can go to our web catalog and provide credit card details to make an immediate purchase. Alternatively, you can complete a credit application to establish a purchase order terms (net 30 days) and submit purchase orders through the web catalog or email.
  2. Can Novodiax ship to multiple shipping locations?
     Once your credit application has been approved, we can set up multiple locations in your online account, and you can select which destination for each purchase.
  3. How much are your kits?
    You can see the price for each kit on our web catalog on logging in your account after it has been approved.
  4. How can I get a quote?
    Please contact us at sales@novodiax.com.
  5. Can Novodiax provide custom bulk packaging of your existing products?
     Topics taken into consideration include the number of tests purchased, size(s) of the requested packaging, frequency of shipments, and regulatory requirements. To find out more, please inquire here.
  6. How much do your custom services cost?
    We need to fully understand your needs and requirements before we can establish a quote. We typically construct our contracts with phase gated milestones that have defined performance requirements before proceeding to the subsequent phase. Please contact us for a custom quote.
  7. How do the kits ship?
    Kits are packed in blue ice and are sent 2nd day (default UPS) in the US and are sent internationally 3 day via best carrier.

Mohs Related Questions

  1. How many tissues can I process with your kits?
    Our polyHRP formulations ship in a ready-to-use bottle that generates drops of approximately 30µl per drop. We recommend approximately 100µl per tissue for a 7µm thick tissue that will fit under a standard 22mm x 22mm cover slip. The most important thing to remember when applying the pHRP-Ab solution is to ensure the entire tissue is covered. Larger and thicker tissues may take more drops, smaller and thinner tissues may take less. Based on that recommendation, a 5ml kit should provide enough reagents to process 50 tissues, a 10ml kit should provide for 100 tissues, and a 30ml kit for 300 tissues.
  2. Is it possible to use the Mart-1 stain with frozen tissues?
    Yes! It is a common misperception that frozen skin sections cannot be stained with an IHC test because the tissue morphology is too compromised during the freezing process.
  3. Why would I need a CK5 for basal and squamous, I already run H&E tests for that?
    H&E staining should provide sufficient detail for most tissues. However, based on feedback from dermatopathologists, approximately 5-10% of all basal and squamous tissues stained with H&E are interpreted with very low confidence. Running an ihcDirect CK5 kit on these tissues will provide absolute confidence in basal/squamous margins on difficult cases.
  4. How can I use your tests to differentiate exocrine glands from carcinoma cells in BCC/SCC?
    The CK5 and CK8/18 can be used in a sequential method to measure carcinoma cells and exocrine glands, respectively.
  5. Are your test kits subject to reimbursement?
    Our FDA registered ihcDirect kits are antibody-based immunohistochemistry tests. As such, we expect these kits to be subject to the same CPT code approvals as any other immunohistochemistry kits. This statement does not constitute reimbursement or legal advice. It is always the provider’s responsibility to determine medical necessity and submit appropriate codes, modifiers, and charges for services rendered. Please contact your local carrier/payer for interpretation of coding and coverage. Novodiax does not promote the use of its products outside their FDA cleared or approved labeling.
  6. Do you have a kit that will help differentiate inflammation from carcinoma in basal cells?
    The ihcDirect CK5 kit can be used to help differentiate inflammation from basal cell carcinoma.
  7. Do you have a kit that will help me evaluate neural invasion?
    Our GFAP (glial fibrillary acidic protein) kit can be used to measure expression in astrocytes and ependymal cells. In the peripheral nervous system, GFAP has been demonstrated in Schwann cells, enteric glial cells and satellite cells of human sensory ganglia. In neoplastic tissues, the antibody may be useful for the identification of astrocytomas and ependymomas.
  8. Running your test is really simple, but I may need some help interpreting slides. Can you help?
    We are happy to review your images and procedures with our staff dermatopathologists. Please contact technical support for further details.
  9. Can mobile Mohs technicians use your kits?
     We currently have multiple mobile Mohs technicians running our ihcDirect tests for Mohs surgeons. While the procedure is incredibly simple, we have seen a wide variation in methods that can affect the reagents and final stain. We highly recommend contacting our technical support before performing our tests.

 

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