SARS-CoV-2 Antigen Detection Kit

Description

Product Name: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)

• 1.1 Package specification 10, 20, 40 tests/kit
• 1.2 Kit Composition

Kit compositions & Components

• Test Card / Colloidal gold-labeled SARS-CoV-2 N protein antibody; SARS-CoV-2 N protein antibody and goat anti-mouse IgG polyclonal antibody coated on NC membrane
• Sample extraction solution / Pbs Buffer
• Sample extraction tube

Package specification

• 2.5 mL × 2/kit (10 tests/ kits / 10 vials)
• 2.5 mL × 4/kit (20 tests / kits / 20 vials)
• 2.5 mL × 8/kit (40 tests / kits / 40 vials)

Performance indicators

• 2.1 Appearance

The outer package is intact, with no damage or contamination, and the label is clear and legible.

• 2.2 Net content

The net content of sample extraction solution should be no less than the labeled value.

• 2.3 Strip width

The strip width should be no less than 2.5 mm.

• 2.4 Liquid migration speed

The liquid migration speed should be no less than 10 mm/min.

• 2.5 Coincidence rate of negative reference

The in-house negative reference is detected, and the negative coincidence rate should be 100%.

• 2.6 Coincidence rate of positive reference

The in-house positive reference is detected, and the positive coincidence rate should be 100%.

• 2.7 Precision

The in-house precision reference is detected and the result should be positive, with uniform chromaticity.

• 2.8 Limit of detection (LOD)

The in-house LOD references are detected, the results of L1 and L2 should be positive and the result of L3 should be negative.

• 2.9 Stability

The original packaging should be stored at 2°C-30°C in a dark and dry place, and the shelf life is tentatively 12 months. Items 2.1-2.8 should be detected respectively within 3 months after the expiration of the original packaging reagent, and the results should meet the requirements of each test item.