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; US FDA

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

Brochure

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

Testimonials

Not available at this time

 

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