COVID-19 Ag Rapid Test Device.

Introduction

Coronavirus disease (COVID-19) is an infectious disease caused by Newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 1,
SARS-CoV-2 is a β-coronavirus, which is an enveloped Unfragmented positive-sense RNA virus2
It is transmitted from person to person
transmission via droplets or direct contact, and infection is presumed
The average incubation period is 6.4 days and its basic reproduction number is
2.24-3.58. Patients with SARS-CoV-2 pneumonia had fever
Most common symptom after cough 3
, Mainly used for IVD assays
COVID-19 uses real-time reverse transcriptase polymerase chain reaction
(RT-PCR) which takes a few hours4
, The availability of a rapid and cost-effective diagnostic test at the point of care is essential for healthcare professionals to help Diagnose patients and prevent further spread of the virus5, will play antigen test
Key role in the fight against COVID-196.

Several variables

• 41FK11 No 2D barcode printed on the inline testers
• 41FK21 contains testers with a 2D barcode printed on the test machine,
Which encrypts the tracking information for the product
Submitted material
• 25 desiccant test kits in individual foil bag
• Buffer (1 x 9 ml/bottle)
• 25 suction tubes
• 25 cap extraction tube
• 1 positive control wiper
• 1 negative control wiper
• 25 sterile nasal swabs for sampling
• 1 tube rack
• 1 quick reference guide
• 1 Instructions for use
Materials are required but not available
• Personal protective equipment as per local recommendations (ie gown/
Lab coat, face mask, face shield/goggles and eye gloves), temporary, biohazard
container
Active ingredients of the main ingredients
• 1 Gold Conjugate Test Device: SARS-CoV-2 Ag . Human IgG Specific Gold
Colloidal and chicken IgY – colloidal gold, test line: mouse monoclonal anti-SARS-CoV-2, control line: mouse monoclonal anti-chicken IgY
• Buffer Tricine, Sodium Chloride, Tween 20, Sodium Azide (<0.1%), Proclin 300
storage and stability
1. The test kit should be stored at a temperature between 2-30°C. no
Freezing the equipment or its components.
Note: When stored in the refrigerator, all kitchen utensils are assembled to room temperature (15-30 °C) for a minimum of 30 minutes prior to
performing the test. Do not open the pouch while components come to room
temperature.
2. The Buffer bottle may be opened and resealed for each assay. The Buffer cap
should be firmly sealed between each use. The Buffer is stable until expiration
date if kept at 2-30 °C.
3. Perform the test immediately after removing the test device from the foil
pouch.
4. Do not use the test kit beyond its expiration date.

5. Shelf life of kit is as stated on outer package.
6. Do not use the test kit if the bag is damaged or the seal is broken.
7. Direct swab specimens should be tested immediately after collection. Yes
immediate testing is not possible, the swab sample can be kept in a
extraction tube filled with extraction buffer (300 μl) at room temperature
(15-30 °C) up to two hours before the test.
warnings
1. For in vitro diagnostic use only. Do not reuse the test device and kit.
components
2. These instructions must be strictly followed by a trained physician
professional to achieve accurate results. All users have to read the instructions.
before running a test.
3. Do not eat or smoke while handling samples.
4. Wear protective gloves while handling samples and wash hands thoroughly.
later.
5. Avoid splashing or aerosol formation of the sample and buffer.
6. Thoroughly clean spills with a suitable disinfectant.
7. Decontaminate and discard all samples, reaction kits, and potentially
contaminated materials (i.e. swab, collection tube, test device) into a biohazard
container as infectious waste and dispose of according to the
local regulations.
8. Do not mix or interchange different specimens.
9. Do not mix reagents from different lots or from other products.
10. Do not store the test kit in direct sunlight.
11. To avoid contamination, do not touch the provided swab head when
opening the swab bag.
12. Sterile swabs should be used for nasal specimen collection only.
13. To avoid cross-contamination, do not reuse sterile specimen swabs.
collection.
14. Do not dilute the collected swab with any solution other than the one provided
extraction buffer.
15. Buffer contains <0.1% sodium azide as a preservative which may be toxic if
ingested When disposed of through a sink, rinse with a large volume of water.7
16. Do not use the positive or negative control swab for sample collection.
Test procedure (see figure)
Nasal swab samples
Note: Healthcare professionals must adhere to personal safety guidelines
including the use of personal protective equipment.

Exam preparation

1. Allow all kit components to reach a temperature between 15 and 30°C before
test for 30 minutes.
2. Remove the test device from the foil bag before use. Place on a floor
horizontal and clean surface.
3. Hold the buffer bottle vertically and fill the collection tube with buffer liquid
until it flows to the fill line of the extraction tube (300 µL).
Caution: If the amount of buffer is over or under, an incorrect
test result may occur.
4. Place the extraction tube in the tube rack.
Collection and extraction of samples from the nasal middle turbinate (NMT)
1. Tilt the patient’s head back 70 degrees. While gently rotating the swab, insert
swab less than an inch (about 2 cm) into the nostril (until you meet resistance on
the turbinates).
2. Rotate the swab five times against the nasal wall, then slowly withdraw it.
the nostril
3. Using the same swab, repeat the collection procedure with the second nostril.
Caution: If the swab breaks during sample collection, repeat
sample collection with a fresh swab.
4. Swirl the tip of the swab into the buffer liquid inside the collection tube, pushing
the wall of the extraction tube at least five times and then squeeze the
swab by squeezing the collection tube with your fingers.
5. Break the swab at the break point and close the lid of the collection tube.
Reaction with test device
1. Open the lid of the drip nozzle at the bottom of the extraction tube.
2. Dispense 5 drops of extracted specimens vertically into the specimen well
(S) on the device. Do not handle or move the test device until the test is
complete and ready to read.

Caution: Bubbles in the extraction tube can lead to errors
results If you cannot create enough drops, this may be due to
obstruction in the dispensing nozzle. Gently shake the tube to release the
obstruction until free droplet formation is observed.
3. Close the mouthpiece and discard the collection tube containing the used swab.
in accordance with local regulations and biohazardous waste disposal protocol.
4. Start the timer. Read the result at 15 minutes. Do not read the results after 20 minutes.
5. Dispose of used device in accordance with local regulations and biohazard.
waste disposal protocol.

 

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