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

Product catalog summary

Product Overview
The O&D Biotech COVID-19 Antigen Rapid Test is a colloidal gold-based diagnostic tool designed for quick and easy detection of COVID-19 antigens. It provides results within 15 minutes and does not require any specialized equipment, making it suitable for large-scale testing. The test can be stored at room temperature (2-30℃) and uses non-invasive sampling methods, offering a cost-effective solution with high sensitivity and specificity.

Product Components and Specifications
The test kit includes 25 test cassettes, extraction tubes with buffer, nasal swabs, and an instruction manual. It is qualified with CE, Germany BfArM & PEI, and EU Common List approvals. The kit has a shelf life of 18 months and supports nasal, oropharyngeal, and nasopharyngeal swab samples.

Testing Procedures

Nasal Swab: Insert swab 1.5cm into nostril, rotate for 15 seconds, and repeat for the other nostril.
Oropharyngeal Swab: Insert swab into the throat, rub over tonsillar areas, and avoid contact with tongue and gums.
Nasopharyngeal Swab: Insert swab into nostril until resistance is met, rotate, and remove.

After sample collection, the swab is placed in the extraction tube, rotated, and the liquid is extracted. Three drops of the sample are added to the test card, and results are read after 15 minutes.

Result Interpretation

Positive: Two red lines appear (control and test lines).
Negative: Only the control line appears.
Invalid: No control line appears, indicating a need to repeat the test.

Clinical Performance
The test demonstrated high clinical sensitivity and specificity across different swab types:

Nasal Swab: Sensitivity 95.65%, Specificity 99.67%
Oropharyngeal Swab: Sensitivity 96.52%, Specificity 99.33%
Nasopharyngeal Swab: Sensitivity 96.52%, Specificity 99.00%

The total coincidence rate was approximately 98.55% for nasal and oropharyngeal swabs, and 98.31% for nasopharyngeal swabs.

Technical Specifications

Limit of Detection: 6.20 x10¹ per mL.
Hook Effect: No hook effect detected at high concentrations.

Catalog excerpts

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, [email protected] 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. Let...

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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 Extraction...

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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 Rapid...

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