KRIS 0 Posted March 29, 2020 Share Posted March 29, 2020 Hello everyone , Our supplier (Immucor)will discontinue the polyclonal Anti-Fyb reagent and will supply a new monoclonal Anti-Fyb, is it necessary to do a validation studies? Thanks and God bless.. Link to post Share on other sites
Malcolm Needs ★ 4,848 Posted March 29, 2020 Share Posted March 29, 2020 Yes. All changes have to be validated. Link to post Share on other sites
Kathyang 47 Posted March 29, 2020 Share Posted March 29, 2020 Yes. We just had to validate the Gamma N-Hance since we had been using ImmuAdd. Link to post Share on other sites
John C. Staley 1,147 Posted March 29, 2020 Share Posted March 29, 2020 Yes, but the validation does not have to be exhaustive and unreasonable. All you need to do is prove that it works as advertised in your lab. David Saikin and Malcolm Needs 2 Link to post Share on other sites
KRIS 0 Posted March 30, 2020 Author Share Posted March 30, 2020 9 hours ago, John C. Staley said: Yes, but the validation does not have to be exhaustive and unreasonable. All you need to do is prove that it works as advertised in your lab. Sir John , in my case I am working in a small hospital and its my first time to work in Blood bank, most of my antibody screening are all negative. I rarely or never got an antibody positive patient in a month. In this case what will be my sample for validation studies? Link to post Share on other sites
David Saikin 1,408 Posted March 30, 2020 Share Posted March 30, 2020 Run some panel cells; negative, heterozygous and homozygous. AMcCord 1 Link to post Share on other sites
John C. Staley 1,147 Posted March 30, 2020 Share Posted March 30, 2020 15 hours ago, KRIS said: Sir John , in my case I am working in a small hospital and its my first time to work in Blood bank, most of my antibody screening are all negative. I rarely or never got an antibody positive patient in a month. In this case what will be my sample for validation studies? David answered your question exactly they way I would have. Validation does not require patient samples, only positive and negative samples in your testing procedures. Follow David's suggestions and you will be fine. The manufacturer has done all the heavy lifting to get it to market. You just need to show it works for you. Link to post Share on other sites
Clarest 20 Posted June 19, 2020 Share Posted June 19, 2020 On 3/29/2020 at 8:15 AM, Kathyang said: Yes. We just had to validate the Gamma N-Hance since we had been using ImmuAdd. Hi Kathyang, When you use either ImmuAdd or Gamma N-Hance, do you do the microscopic check for the negative reaction at AHG phase? Link to post Share on other sites
Kathyang 47 Posted June 23, 2020 Share Posted June 23, 2020 No we don't use the microscope. David Saikin 1 Link to post Share on other sites
AMcCord 1,274 Posted July 3, 2020 Share Posted July 3, 2020 On 6/19/2020 at 3:49 PM, Clarest said: Hi Kathyang, When you use either ImmuAdd or Gamma N-Hance, do you do the microscopic check for the negative reaction at AHG phase? A magnification aid is optional for N-Hance. It could be an agglutination viewer, rather than a microscope. Malcolm Needs, John C. Staley, Ensis01 and 1 other 4 Link to post Share on other sites
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