Abstract: ABSTRACT “A METHOD FOR DETECTING AND QUANTIFYING TARGET BIOLOGICAL AGENT” The present disclosure relates to a platform technology for analysing target biological agent based on lateral flow assay (LFA) in a biological sample using a serial dilution approach. The present disclosure determines and semi-quantifies the target biological agent such as virus (both active and inactive virus particles) in a sample at any stage of vaccine manufacturing. 5 The LFA based method of the present disclosure is improved vis-à-vis conventional analytical methods such as plaque assay; satisfies the WHO criteria of ASSURED; and is a simple, reliable, rapid, safe, cost-effective platform technology for analysing the presence of virus in samples (e.g., vaccine samples at different manufacturing stages), measuring the limit of detection (LOD) of LFA strip, preparing ready reckoner based on LOD and semi10 quantifying the virus by LFA using serial dilutions.
We Claim:
1. A method for analysing a biological sample based on lateral flow assay (LFA),
wherein the method comprises:
a) mixing the biological sample with a diluent by serial dilution method to obtain at
5 least one dilution (D);
b) loading the at least one dilution (D) on the LFA strip;
c) determining presence or absence of a colour band on the LFA strip which
corresponds to presence or absence of a target biological agent present in the at
least one dilution (D) of the biological sample;
10 d) measuring a limit of detection (LOD) of the LFA strip;
e) preparing a ready reckoner of the target biological agent titers based on the LOD
of the LFA strip and actual established titer of a plaque assay; and
f) semi-quantifying the target biological agent in the biological sample based on the
target biological agent titers of the ready reckoner and optionally validating with
15 plaque assay.
2. The method as claimed in claim 1, wherein the biological sample comprises the target
biological agent, and said biological sample is selected from the group comprising of
viral vaccine, microorganisms, blood and blood components, allergenics, somatic
cells, tissues and recombinant therapeutic proteins.
20 3. The method as claimed in claim 1, wherein the target biological agent is a
microorganism selected from the group comprising of virus, bacteria, archaea, fungi
(yeasts or molds), algae, protozoa, and any combination thereof.
4. The method as claimed in any one of claims 1 to 3, wherein the target biological agent
is a virus selected from the group comprising of respiratory syncytial virus (RSV),
25 rabies virus, dengue virus, influenza virus, zika virus, West Nile virus, yellow fever
virus, chikungunya virus, herpes simplex virus (HSV), cytomegalovirus (CMV),
Middle East respiratory syndrome (MERS) virus, Severe acute respiratory syndrome
(SARS) virus, SARS-CoV-2 corona virus, SARS-CoV-2 Ebola virus, Covid-19, Rift
valley, Epstein-Barr virus, Varicel
| # | Name | Date |
|---|---|---|
| 1 | 202421003430-STATEMENT OF UNDERTAKING (FORM 3) [17-01-2024(online)].pdf | 2024-01-17 |
| 2 | 202421003430-PROVISIONAL SPECIFICATION [17-01-2024(online)].pdf | 2024-01-17 |
| 3 | 202421003430-FORM 1 [17-01-2024(online)].pdf | 2024-01-17 |
| 4 | 202421003430-DRAWINGS [17-01-2024(online)].pdf | 2024-01-17 |
| 5 | 202421003430-DECLARATION OF INVENTORSHIP (FORM 5) [17-01-2024(online)].pdf | 2024-01-17 |
| 6 | 202421003430-Proof of Right [02-02-2024(online)].pdf | 2024-02-02 |
| 7 | 202421003430-FORM-26 [02-02-2024(online)].pdf | 2024-02-02 |
| 8 | 202421003430-DRAWING [16-01-2025(online)].pdf | 2025-01-16 |
| 9 | 202421003430-CORRESPONDENCE-OTHERS [16-01-2025(online)].pdf | 2025-01-16 |
| 10 | 202421003430-COMPLETE SPECIFICATION [16-01-2025(online)].pdf | 2025-01-16 |