ISSN 2394-5125
 

Research 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 for diagnosis of infectious diseases such as SARS-CoV-2. These tests are very sensitive but sometimes deliver nonspecific results that lead to diagnostic errors. Thus, reliability of these test kits needs to be examined. Such test kits are composed of protein conjugated uncut sheets labelled with markers (mostly AuNPs) and nitrocellulose membrane (NCM) coating. In most countries, the un-cut sheets are purchased from vendors and are assembled to compose final test kits. Due to specific antigen-antibody-protein design and stability, these sheets often have specificity issues. For the development of an accurate rapid test kit various factors to be addressed are evaluation of un-cut sheets, quality attributes during sheet cutting and scale up studies to ensure the effectiveness of kits. Present review presents a discussion on various critical quality attributes essential for kit assembly in order to enhance the reliability of the kits and fulfil the regulatory scrutiny.

Key words: Rapid test kits, immunochromatographic diagnostic kits, lateral flow, gold nanoparticles, COVID-19 Kit.


 
ARTICLE TOOLS
Abstract
PDF Fulltext
How to cite this articleHow to cite this article
Citation Tools
Related Records
 Articles by Prince Manta
Articles by Deepak N Kapoor
Articles by Gurmeet Kour
Articles by Manpreet Kour
Articles by Abhishek Kumar Sharma
on Google
on Google Scholar


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=131020 [Access: September 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 September 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