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

Description

Intrivo Diagnostics CareStart™ COVID-19 Antigen Test Kit – 20 Tests (RCHM-02071)
Visual Read | Rapid Results in 10 Minutes | For Use at Point of Care

Product Overview:
The CareStart™ COVID-19 Antigen Test by Intrivo Diagnostics is a rapid lateral flow immunochromatographic assay designed to detect the nucleocapsid protein antigen of SARS-CoV-2. Ideal for point-of-care use, this test delivers visual results in just 10 minutes from nasopharyngeal swab samples, making it a valuable tool for quickly identifying both symptomatic and asymptomatic COVID-19 cases.

Kit Contents (20 Tests):

• (20) Test Devices (Cassette Format)

• (20) Assay Buffers

• (20) Extraction Vials with Caps

• (20) Nasopharyngeal Specimen Collection Swabs

• (1) Positive Control Swab

• (1) Negative Control Swab

Key Features:

• Sample Type: Nasopharyngeal (NP) Swabs

• Reading Method: Visual Read

• Result Time: 10 minutes

• Storage: USP Controlled Room Temperature

• Test Method: Lateral Flow Immunochromatographic Assay

• Format: Cassette

• Country of Origin: USA

• CLIA Waived: Authorized for use in point-of-care settings under a CLIA Certificate of Waiver, Compliance, or Accreditation

Clinical Use & Limitations:

• A positive result indicates the presence of SARS-CoV-2 antigens; however, clinical correlation with patient history and additional diagnostic data is recommended.

• A negative result is presumptive. If necessary, confirmation with a molecular test should be considered, especially in the context of clinical symptoms.

• This test is intended for use within the first five days of symptom onset and is suitable for direct swab specimens or those collected in BD universal transport media.

• Results should not be the sole basis for treatment or infection control decisions.

Application:
The CareStart™ COVID-19 Antigen Test is a crucial tool in the ongoing efforts to control the pandemic, providing a fast, reliable, and minimally invasive method to screen individuals suspected of COVID-19.