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COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C

COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C
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COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C - 1

O&D BIOTECH COVID-19 ANTIGEN RAPID TEST Colloidal Gold CONTACT US Beijing O&D Biotech Co., Ltd. Website: www.odbio.com Contact: Grace Zhang, zhangjh@odbio.com Address: West, Floor 4, Building 1, No.1, Shunqiang Road, Renhe Town, Shunyi District, Beijing, China

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COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C - 2

Colloidal Gold Instant results within 15 minutes Easy to use, no equipment required Room temperature storage (2-30℃) Non-invasive sampling Cost-effective solution for large-scale testing

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COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C - 3

Product Components Test cassette Extraction tube Order Information Product Name COVID-19 Antigen Rapid Test Packing Size Sample Type Nasal/oropharyngeal/nasopharyngeal swab Storage Condition Shelf Life 25x Test cassettes (individually packed) 25x Extration tubes with extraction buffer inside 25x Nasal swabs 1x Instruction for use CE, Germany BfArM & PEI, France Approval, EU Common List

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COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C - 4

For Nasal Swab Sample 1. Take out the Swab supplied in the kit, be careful not to touch the head end of the swab with your hand. 2. Gently insert the swab into the nostril. The insertion depth should not exceed 1.5cm (about 3/4 of the white fiber part of the head end of the swab enters the nostril) 3. Slowly rotate the swab along the inside of nostril for 15 seconds. 4. Gently pull out the swab. 5. Repeat steps 2-4 on the other nostril with the swab. For Oropharyngeal Swab Sample 1. Take out the Swab supplied in the kit, be careful not to touch the head end of the swab with your hand. 2....

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COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C - 5

1. Remove the sealing aluminum foil from the Extraction tube bottle, and place it on the shelf. 2. Place the swab sample into the Extraction tube (contains Extraction Buffer), touch the bottom of the tube with the swab tip. Vigorously rotate and twist the swab against the side of the tube at least 15 times. 3. Squeeze the sides of the Extraction tube to obtain as much liquid as possible and take out the swab. 4. Close the Extraction tube cap and press it tightly, put the swab back into the package. Safely dispose of the swab and the package. 5. Add 3 drops extracted sample from the...

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COVID-19 Antigen Rapid Test for Professional Use-3 in 1-O&D Biotech 00013C - 6

For Nasal Swab Sample The clinical performance of the device was established with a study using 415 Nasal swabs. Clinical diagnosis COVID-19 Antigen Rapid Test Total Positive Negative Positive 110 1 111 Negative 5 299 304 Total 115 300 415 The assay demonstrated clinical sensitivity 95.65% (95% CI: 90.14%-98.57% ) and clinical specificity 99.67% (95% CI: 98.16%-99.99%), The total coincidence rate 98.55% (95% CI: 96.88%-99.47% ). For Oropharyngeal Swab Sample The clinical performance of the device was established with a study using 415 Oropharyngeal swabs. Clinical diagnosis COVID-19 Antigen...

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