Internal standards for Ivd
What type of cells are formulated in Nattrol Controls?
NATtrol RP controls are basically the formulation consisting of various cells or particles for example bacterial cells and certain viral particles that are being chemically stable and then modified. Moreover, these chemically stable particles are also quite refrigerator stable as well. These controls are manufactured or designed to check the performance of all the Nucleic Acid tests to detect whether there are any bacterial or viral nucleic acids. These controls have certain intact organisms and it should be used for clinical specimens as well.
How will the NATtrol inactivation be carried out and how will it be verified?
Inactivation of these Controls would be carried out on the viral and bacterial stocks in order to formulate controls. Verification of these inactivation controls can be checked by the presence or absence of viral/bacterial growth. Manufacturing of this product is followed by the use of purified protein matrix by treating it with 0.9% sodium azide. Moreover, this product was manufactured from certain materials that have been tested as non-reactive donors. Testing of materials would be done by HIV-1 and HCV by FDA approved nucleic acid test methods.
NATtrol multi markers can be used in vitro how? What’s the basic principle behind these markers?
These multi markers consist of in vitro diagnostic external controls that are destined to be used with qualitative molecular assays. To monitor daily test variations, individual operator variation, lot to lot test kit performance and individual operator variation routine and repetitive use of external run controls can be used in this regard.
These multi markers have some viral or bacterial cells that have been already inactivated. Moreover, these controls are effectively designed to monitor the effectiveness of amplification, extraction and detection as well in certain Nucleic Acid test.
Some precautionary measures and instructions are necessary while handling these controls. What are these precautions?
Handling of these products are important enough as they contain inactivated organisms but still they are potentially infectious so a lot of care is needed in this regard. Apart from this cross contamination is also a major drawback so to avoid this always use separate pipette tips for all the reagents.
Moreover, these products are manufactured for only research related work and quality assurance. Also, these products are not intended to be used inside the human body as well.
Storage requirements of these products should be in between 2-8 degree Celsius.