Laboratory Test Request

FDA Performance Characteristics Evaluation of SARS-CoV-2 Antigen and Antibody Detection Test Kits

Project Description

USA FDA GMP Laboratory needed performance evaluation studies as per US-FDA requirement of an antibody-antigen SARS-CoV-2 Detection Test Kits:
Performance Characteristics Evaluation" done for the above mentioned SARS-CoV-2 Antigen and Antibody detection test kits.
The main components of the required analysis and expected reports regarding the Performance Characteristics Evaluation are:
Limit of Detection (LoD)

Cross-reactivity

Microbial Interference Studies

Endogenous Interference Substances Studies

High-dose Hook Effect

Specimen Stability

Clinical Evaluation

Specimen type for the antigen/antibody test

Specimen collection date and time for the antigen/antibody test

Specimen testing date and time for the antigen/antibody test

VTM type, as applicable, for the antigen/antibody test and PCR

Antigen/Antibody test result

Specimen type for RT-PCRS

Specimen collection date and time for RT-PCR test

Specimen testing date and time for RT-PCR test

Patient age and gender, if available

Number of days' post-onset of patient symptoms

RT-PCR test value results (Ct values)

RT-PCR test results (+/-)

Name of RT-PCR used as the comparator

Name of the antibody test used as the comparator.

Please let us know for the possibility of conducting the above mentioned studies.

Project Information

Number:21-02543

Industry:Medical Devices

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Antibodies,Antigens and Antibodies,Biologics,Biotechnology,Cell Lines and Cell Cultures,Clinical Diagnostic,Healthcare and Medical,Immunotherapy and Immunotherapeutics,In-Vitro Diagnostics,Medical Devices,Medical Technology,

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