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ezLabs® COVID-19 Antigen Test

ezLabs® COVID-19 Antigen Test

Product catalog summary
Overview: The ezLabs® COVID-19 Antigen Test is a rapid in vitro immunochromatographic assay designed for the qualitative detection of SARS-CoV-2 virus antigens in the human nasopharynx.
Collection: Proper specimen collection, storage, and transport are crucial for test performance. Specimens should be tested immediately after collection, and transport media should not be used.
Procedure: Follow the instructions provided in the Instructions for Use (IFU).
Result Interpretation: The document does not provide specific details on result interpretation, indicating that users should refer to the IFU.
Characteristics and Performance: The test's analytical sensitivity varies with different strains of SARS-CoV-2, with limits of detection ranging from 3.16 x102 to 9.55 x102 TCID50/mL. Recombinant N Protein detection is less than 1 ng/ml.
Materials Provided: The kit includes the ezLabs® COVID-19 Antigen Test, extraction buffer, sample extraction tube, nasopharyngeal swab, and instructions for use.
Ordering Information: The reference number for ordering is M101-091062, and each kit contains 20 tests.
Clinical Data: In a study with 213 samples, the test showed a sensitivity (PPA) of 93.7% and a specificity (NPA) of 98.8%. The positive predictive value (PPV) is 99.2%, and the negative predictive value (NPV) is 91.4%.
Contact Information: Micropoint Bioscience, Inc. is located in Santa Clara, CA, USA, with contact details provided for both the USA and European offices.
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Catalog excerpts

ezLabs® COVID-19 Antigen Test-1

ezLabs® COVID-19 Antigen Test ezLabs® COVID-19 Antigen Test is a rapid In vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 virus antigen present in human nasopharynx. COLLECTION: Proper specimen collection, storage, and transport are critical to the performance of this test. Specimens should be tested as soon as possible after collection. DO NOT USE TRANSPORT MEDIA PROCEDURE (Follow instruction in the IFU) RESULT INTERPRETATION Characteristics and Performance Analytical Sensitivity Item Ordering information ezLabs® COVID-19 Antigen Test Extraction buffer Sample extraction tube Nasopharyngeal Swab Instructions for Use Materials Provided Clinical Data N= 213 ezLabs Positive Negative Sens/PPA Spec/NPA PCR Comparator Positive Negative 119 1 8 85 PPV NPV REF: M101-091062 ezLabs® COVID-19 Antigen Test (20 tests/kit) European Office 3521 Leonard Court, Santa Clara, CA 95054, USA Tel: +1 (408) 588 1682 Fax: +1 (408) 588 1620 Mail: [email protected] Web: http://www.micropointbio.com

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