Chembio SCoV-2 Ag Detect™ Rapid Test Kit

The SCoV-2 Ag Detect Rapid Test Kit can be used for testing symptomatic or asymptomatic patients using a direct nasal sample that gives results in about 20 minutes.

Supplier:  Chembio 9020218

Catalog No. 23-999-116

Description

SCoV-2 Ag Detect™ Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

• Easy to use POC SARS-CoV-2 Nucleoprotein antigen test that can performed in many settings with symptomatic or asymptomatic patients
• Identifies acute infection in symptomatic patients with high accuracy: PPA (Sensitivity) 86.67%, NPA (Specificity) 100%
• Direct nasal sample
• Results in approximately 20 minutes
• No instrumentation needed

Specifications

• Content And Storage: 15°C to 30°C
• Clia Complexity: Waived
• Sample Type: Direct Nasal Swab
• Type: SARS-CoV-2 Rapid Antigen Test
• For Use With (Application): Intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
• Quantity: 50 Tests/Kit
• Specificity: 1
• Form: Liquid

• CE Marker: Yes
• Detectable Analytes: SARS-CoV-2 Antigens
• Sensitivity: 0.8667
• Disposable: Yes
• Includes: Pouched cassettes, 1 positive control, 1 negative control, sterile swabs, lysis buffer
• Species: Human
• Test Time: 20 Min.

Safety and Handling

ShelfLife : 6 Months