ISSN 2394-5125
 

Review Article 


CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW

Prince Manta, Deepak N Kapoor, Gurmeet Kour, Manpreet Kour, Abhishek Kumar Sharma.

Abstract
Over the last two decades, various Immune assays utilizing gold nanoparticles have been developed that can be habituated to study the antigen-antibody identification, especially for infectious diseases (e.g.SARS-CoV-2) diagnosis. These gold nanoparticle-labeled immunochromatographic assays have been utilized for developing biosensors and provide a captivating denotes for performing bioassays on-field. These tests are very sensitive and sometimes engender nonspecific results that lead to diagnostic errors. Therefore, scientists are fascinated by examining the reliability of these test kits. Such test kits are composed in uncut sheet structures after protein conjugation labeled with markers (mostly AuNPs) and nitrocellulose membrane (NCM) coating.In most countries and in India for the easy & expeditious production in current situation of global virus pendamic, the rapid test kits are manufactured after purchasing an un-cut sheet from vendors and are assembled to compose final the test kits after cutting to pieces. Often it is perceived that there is very little information provided or available about these un-cut sheets. Due to the specific antigen – antibody-protein design and stability, these sheets often have specific efficiency issues. To develop a better rapid test kit, not only is the manufacturer's pre-un-cut sheet evaluation is very crucial, but it is also necessary to monitor the essential quality attributes during sheet cutting & scale-up to maintain the potency of the kits. Herein, we are including, all the critical quality variables or factors to be considered during kits assembly to enhance the reliability of the kits and to evade regulatory scrutiny.

Key words: Rapid test kits,Point –Of-Care, Lateral Flow, Diagnostic, COVID-19 Kit.


 
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How to Cite this Article
Pubmed Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma. CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW. JCR. 2020; 7(19): 377-384. doi:10.31838/jcr.07.19.48


Web Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma. CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW. http://www.jcreview.com/?mno=102138 [Access: July 15, 2020]. doi:10.31838/jcr.07.19.48


AMA (American Medical Association) Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma. CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW. JCR. 2020; 7(19): 377-384. doi:10.31838/jcr.07.19.48



Vancouver/ICMJE Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma. CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW. JCR. (2020), [cited July 15, 2020]; 7(19): 377-384. doi:10.31838/jcr.07.19.48



Harvard Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma (2020) CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW. JCR, 7 (19), 377-384. doi:10.31838/jcr.07.19.48



Turabian Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma. 2020. CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW. Journal of Critical Reviews, 7 (19), 377-384. doi:10.31838/jcr.07.19.48



Chicago Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma. "CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW." Journal of Critical Reviews 7 (2020), 377-384. doi:10.31838/jcr.07.19.48



MLA (The Modern Language Association) Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma. "CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW." Journal of Critical Reviews 7.19 (2020), 377-384. Print. doi:10.31838/jcr.07.19.48



APA (American Psychological Association) Style

Prince Manta, Deepak N Kapoor, Gurmeet Kour , Manpreet Kour , Abhishek Kumar Sharma (2020) CRITICAL QUALITY ATTRIBUTES OF RAPID TEST KITS – A PRACTICAL OVERVIEW. Journal of Critical Reviews, 7 (19), 377-384. doi:10.31838/jcr.07.19.48





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