MDx COVID-19 Ag Rapid Test

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MDx COVID-19 Ag Rapid Test is a lateral flow immunochromatography assay for the qualitative detection and diagnosis of SARS-CoV-2 in nasopharyngeal swabs without using viral transport media.
• Minimum Order Quantity (MOQ): 10000 tests
• Seller Name: KALMIC
• Seller Location: South Korea
• Warranty Term: Not applicable
• Regulatory Approvals: CE; ISO 13485

Additional information

Weight 50 kg
Dimensions 58 × 50 × 43 cm

Description

MDx COVID-19 Ag Rapid Test is a lateral flow immunochromatography assay for the qualitative detection and diagnosis of SARS-CoV-2 in nasopharyngeal swabs without using viral transport media. This test can be a supplemental diagnostic assay to real-time PCR assay in advanced laboratory for rapid diagnosis of COVID-19 infection. In addition, this rapid test can be utilized in limited facility by operators with minimum training.

Key Features

Usability
The MDx COVID-19 Ag Rapid Test is easy to use. It gives results within 15-20 minutes to aid the diagnosis of COVID-19 infection. It is recommended for use as an initial screening test of COVID-19.

Clinically Evaluated
Performance characteristics for the MDx COVID-19 Ag Rapid Test for the rapid detection of SARS-CoV-2 antigen was conducted at a clinical center during the 2020 SARS-CoV-2 pandemic situation. A total of 115 prospective specimens were tested using the MDx COVID-19 Ag Rapid Test. These specimens consisted of nasopharyngeal swabs from patients. The performance of MDx COVID-19 Ag Rapid Test was compared to real-time PCR and indicated that it was reliable for testing of COVID-19 associated clinical specimens.

Specifications

Diagnostic Performance

  • Sensitivity: 83.8% (Ct value<35), 93.6% (Ct value <30), and 95.8% (Ct value <25)
  • Specificity: 100%

Standard Accessories

Each test includes:

  • Sample dilution buffer (1x)
  • Nasopharyngeal specimen collection swab (NP swab) (1x)
  • Dropper cap (1x)

Optional Accessories & Add-ons

Not applicable

Product Documents, Manuals & Brochures

United States
kalmic rapid test brochure thumb

Brochure

kalmic covid rapid test insert thumb

Insert

Regulatory Certificates

Not available at this time

 

Videos

Not available at this time

 

FAQ

Not available at this time

 

Studies & Trials

Not available at this time

 

Package Contents

  • 20x COVID-19 Ag Test Devices
  • 20x Sample dilution buffer
  • 20x Nasopharyngeal specimen collection swab (NP swab)
  • 20x Dropper cap
  • 1x Instruction manual

Warranty

Not applicable
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