S.N. | Parameter | Specification |
Name of the manufacturer | ||
Country of origin | ||
1 | IVD Method | Lateral Flow, immunochromatography based qualitative detection (visual Reading of bands without the aid of any devices) |
2 | Sample | Oropharyngeal swab/Nasopharyngeal swab/Nasal Swab |
3 | Target | SARS COV-2 Specific Antigen |
4 | Sensitivity | Above 80% |
5 | Specificity | 95% of above |
6 | Time | Whole process time of testing (The antigen extraction as well as run time) should not exceed 30 minutes |
7 | Additional Supplies | At least one swab stick for sample collection
Reagents and all consumables required for test |
8 | Storage Temperature | All of the supplies should have storage temperature between 2-300 C |
9 | Remaining Self-life | At least 6 months at the time of acceptance of goods |
10 | Certification | US FDA or USFDA (EUA) or WHO EULor EU-CE |