CE COVID-19 Antigen Test kit (Colloidal Gold)
For Professional Use
CE
INTENDED USE
COVID-19 Antigen Test kit (Colloidal Gold) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human saliva. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 Antigen Test kit (Colloidal Gold) must be confirmed with alternative testing method (s) and clinical findings
PACK FORMATS
1test/box 20 tests/box 50 tests/box 100 tests/box
INTRODUCTION
The novel coronaviruses belong to the βgenus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection: asymptomatic only infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
PRINCIPLE
The COVID-19 Test Kit (Colloidal Gold Method) is a colloidal gold immunochromatographic assay. It detects the nucleocapsid protein on the surface of COVID-19.
The test uses COVID-19(SARS-CoV-2) antibody (test line T) and goat ant-mouse lgG (control line C) immobilised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to another COVID-19 (SARS-Cov-2) antibody conjugated with colloid gold and mouse lgG-gold conjugates. When the processed buffer containing the sample is added to the sample well, COVID-19 (SARS-CoV-2) will combine with the COVID-19 antibody conjugate to form an antigen-antibody complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the COVID-19 antibody of test line T, the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result.
The test contains an quality control (control line C), which should show a burgundy color band of goat anti-mouse polyclonal antibody combined with the colloidal gold conjugate in the gold label pad, regardless ofthe color on any other test line.
MATERIALS SUPPLIED
Sealed pouches each containing a test cassette, a desiccant
Sampling cotton swabs (as saliva swab)
Antigen extraction buffer
Antigen extraction tube
Paper workbench (The small one-test-box can be used as a workbench)
Instruction for use
MATERIALS REQUIRED BUT NOT PROVIDED
Timer
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (4-30℃). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
DO NOT FREEZE
Do not use beyond the expiration date.
After opening the sealed pouch, use the test as soon as possible within 60 minutes.
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. These instructions must be strictly followed by a trained healthcare professional to achieve accurate results. All users have to read the instruction prior to performing a test.
3. Do not use it if the tube/pouch is damaged or broken.
4. Wear protective gloves while handling specimens and wash hands thoroughly afterwards.
5. Avoid splashing or aerosol formation of specimen and buffer.
6. Clean up spills thoroughly using an appropriate disinfectant.
7. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (such as swab, extraction tube, test device) in a biohazard container as if they were infectious waste and dispose according to applicable local regulations.
8. Do not mix or interchange different specimens.
9. Do not mix reagent of different lots or those for other products.
10. Do not store the test kit in direct sunlight.
11. To avoid contamination, do not touch the head of provided swab when opening the swab pouch.
12. The provided swabs in the package should be used only for saliva specimen collection,
13. To avoid cross-contamination, do not reuse the swabs for specimen collection.
14. Do not dilute the collected swab with any solution except for the provided extraction buffer.
15. Test is for single use only. Do not re-use under any circumstances.
16. Do not perform the test in a room with strong air flow, such as electric fan or strong air-conditioning.
SPECIMEN COLLECTION
1. COVID-19 Antigen Test kit (Colloidal Gold) can be performed using saliva swab.
2. Testing should be performed immediately after specimen collection.
3. Bring specimens to room temperature prior to testing.
4. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
5. Avoid chewing or swallowing during the sampling period. The saliva sample should be tested immediateły after sampling.
TEST PROCEDURE
Allow test cassette, Antigen extraction buffer, specimen and controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Make sure there are no food residue in the mouth before sampling. Take sampling at least 30 minutes after eating, drinking. gargling or teeth brushing. And intentional multi-coughing is recommended before sampling. Remove the swab package, keep the swab on the root of tongue until the swab tip being fully soaking by saliva.
2. Place the antigen extraction tube on the workbench. Place the antigen extraction buffer bottle vertically downward, squeeze the bottle to make the buffer drip freely into the antigen extraction tube without touching the edge of the tube, and add all of the antigen extraction solution (about 450ul) to the antigen extraction tube.
3. Put the swab specimen into the antigen extraction tube pre-added with the antigen extraction buffer, and rotate the swab about 10 times while pressing the swab head against the tube wall to release the antigen in the swab then let it stand for about 1 minute.
4. Remove the swab while squeezing the tip of the swab so that as much liquid in the swab can be discharged as possible. Dispose of used swabs in accordance with biohazard waste disposal methods.
5. Install the dripper on the antigen extraction tube and cap it tightly, and let it stand for about 1 minute.
6. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
7. Place the test device on a clean and level surface.
8. Transfer 3 drops (about 100μL) of mix Liquids to the sample well of the test card (or use a pipette to add 100μL) and start the timer.
9. Wait for the test result of the reagent. The result should be read in 15 minutes, Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no COVID-19 antigen is detected in the specimen. The result is negative.
POSITIVE
In addition to the presence of C band. if T band is developed, the test indicates for the presence of COVID-19 antigen in the specimen. The result is COVID-19 positive.
INVALID
Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
LIMITATIONS
1. Use fresh samples whenever possible.
2. Optimal assay performance requires strictly adherence to the assay procedure described in Instruction for use. Deviations may lead to aberrant results.
3. A negative result for an individual subject indicates absence of detectable COVID-19 antigen. However, a negative test result does not preclude the possibility of exposure to or infection with COVID-19.
4. A negative result can occur if the quantity of the COVID-19 antigen present in the specimen is below the detection limits of the assay, or failed to collect the COVID-19 antigen in the saliva of the patient.
5. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
PERFORMANCE CHARACTERISTICS
Clinical Sensitivity, Specificity and Accuracy
A total of 397 Saliva specimens were tested in this study. The COVID-19 clinical specimens contain specimens from individuals with symptoms within 7 days. The results of test reagent and control reagent both were 230 negative specimens and 167 positive specimens. The data were collected in 2021.03.02~2021.03.11, and the sensitivity and specificity calculated were valid in this study.
COVID-19 Antigen Test Kit vs PCR
Latest version 8.129.04.022 A10 Issued Date: 2023.01.03
