Product Specifications
| Specification | Details |
| Manufacturer / Brand | Quidel Corporation / QuickVue® |
| Manufacturer # / SKU | 20387 / 20388 |
| CLIA Status | CLIA Waived |
| Test Type | Lateral-Flow Immunoassay (Antigen) |
| Target Antigen | SARS-CoV-2 Nucleocapsid Protein |
| Specimen Type | Anterior Nasal (NS) Swab |
| Time to Results | 10–15 Minutes |
| Storage | Room Temperature (15°C to 30°C) |
| Kit Contents | 25 Test Strips, Tubes, Reagents, Swabs, Control Swabs |
Key Features
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Rapid Diagnostic Speed: Provides definitive results in as little as 10 minutes, facilitating immediate isolation and management of positive cases.
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Simplified Procedure: No specialized equipment or instrumentation is required. The “Dipstick” format involves a simple three-step process: Swab, Rotate, and Read.
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High Performance: Offers excellent clinical sensitivity in patients within the first five days of symptom onset.
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Built-in Quality Control: Each strip includes a procedural control line that turns blue to confirm the test is valid and the sample has successfully migrated.
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Scalable Testing: The 25-test format is optimized for high-throughput environments, and room-temperature storage ensures the kit is ready for immediate deployment.
Clinical Applications
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Screening Programs: Regular testing in congregate settings like nursing homes, schools, and offices.
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Acute Care: Rapidly differentiating COVID-19 from other respiratory illnesses in urgent care or emergency room settings.
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Travel & Events: Professional verification for travel requirements or safe entry to large gatherings.
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Instructions for Use
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Collect: Swab both nostrils using the provided sterile nasal swab.
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Process: Place the swab into the pre-filled reagent tube and rotate it vigorously 3 times. Let the swab sit for 1 minute.
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Test: Remove the swab while squeezing the tube to extract all liquid. Insert the QuickVue test strip into the tube.
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Read: Results are ready at 10 minutes. Do not interpret results after 15 minutes.
⚠️ Usage Note: This test is for professional use only (Point-of-Care). It is not intended for at-home use.
⚠️ Safety Alert: All clinical specimens must be handled with universal precautions and disposed of as biohazardous waste.
⚠️ Storage: Do not freeze the kit. Keep the test strips in their sealed pouches until the moment of testing to prevent degradation from humidity.
