Intrivo Diagnostics CareStart™ RCHM-02071 20 Tests Antigen Detection Visual Read Covid-19 Antigen Test - 20 Test/Kit

Intrivo Diagnostics CareStart™ RCHM-02071 20 Tests Antigen Detection Visual Read Covid-19 Antigen Test - 20 Test/Kit

Antigen Test, Covid-19, (20) Test Devices, (20) Assay Buffers, (20) Extraction Vials & Caps, (20) Specimen Collection Swabs, (1) Positive & (1) Negative Control Swab Contents, 20 Tests, Visual Read Reading, Nasopharyngeal Swab Sample, USP Controlled Room Temperature Storage Requirements, Cassette Test Format, Lateral Flow Immunochromatographic Assay Test Method, Antigen Detection Test, 10 min Time To Results

Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.

Feature:

• Nasopharyngeal / NP Swabs
• 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
• Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses
• Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed, negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
• CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset
• Lateral flow assay
• Minimally invasive specimen collection

Attribute:

Type: Covid-19
Contents: (20) Test Devices, (20) Assay Buffers, (20) Extraction Vials & Caps, (20) Specimen Collection Swabs, (1) Positive & (1) Negative Control Swab
Number of Tests: 20
Reading Type: Visual Read
Sample Type: Nasopharyngeal Swab
Storage Requirements: USP Controlled Room Temperature
Test Format: Cassette
Test Method: Lateral Flow Immunochromatographic Assay
Test Type: Antigen Detection
Time To Results: 10 min
Country of Origin: USA

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