User manual for RCD-802 Coronavirus Antigen Test Kit, covering sample types, procedure, result interpretation, and precautions for professional in vitro…
This document provides instructions for using the RCD-802 Coronavirus Antigen Test Kit for professional in vitro diagnostic purposes. It details sample collection methods for nasal, throat, anterior nasal, and saliva specimens, step-by-step testing procedures, result interpretation (positive, negative, invalid), and critical safety and storage precautions. The kit uses lateral flow immunoassay technology to detect SARS-CoV-2 antigens in samples.
Performance metrics are included, such as sensitivity and specificity compared to PCR, with data indicating high accuracy for different specimen types. The manual emphasizes that results are preliminary and must be confirmed with other testing methods, and that the test is not intended for home or non-professional use. This manual is written in Chinese.
| Detection Method | Lateral flow immunoassay |
|---|---|
| Sample Types | Nasal swab, throat swab, anterior nasal swab, saliva |
| Detection Target | SARS-CoV-2 nucleocapsid protein |
| Read Time | 15 minutes (results invalid after 20 minutes) |
| Sensitivity (Nasal Swab) | 96.49% (93.11%~99.87%) |
| Specificity | 100% (99.82%~100%) |
The kit can test nasal swabs, throat swabs, anterior nasal swabs, and saliva samples.
Results should be read within 15 minutes; results are invalid after 20 minutes.
No, this test is intended for professional in vitro diagnostic use only.