CE COVID-19 Test Kit (Colloidal Gold Method)
FOR Self-Testing Use
CE 1434
INTENDED USE
COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid,
qualitative detection of antigen to 2019 Novel Coronavirus in human nasal cavity. This test provides only a
preliminary result for self-testing. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold
Method) must be confirmed with alternative testing method(s) and clinical findings.
PACK FORMATS
1 test/box, 5 tests/box, 20 tests/box
INTRODUCTION
The novel coronaviruses belong to the β genus. 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;
asymptomatically 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 anti-mouse IgG (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 IgG-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 confirms a reactive test result. Absence of a
colored band in the test region indicates a non-reactive test result.
The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex goat
anti-mouse IgG/mouse IgG-gold conjugate regardless of the color development on any of the test
bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
MATERIALS COMPOSITION
COVID-19 Test Kit (Colloidal Gold Method) mainly contains the following composition:
COVID-19 antibody of Nucleocapsid protein
Goat anti-mouse IgG
Chloroauric acid
Nitrocellulose membrane
MATERIALS SUPPLIED
Sealed pouches each containing a test cassette, a desiccant
Sampling cotton swabs (for nasal cavity sampling only)
Antigen extract buffer
Antigen extraction tube
Paper workbench (The small one-test-box can be used as a workbench)
Instructions for use
MATERIALS REQUIRED BUT NOT PROVIDED
Timer
STORAGE AND STABILITY
The kit can be stored at 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.
WARNINGS AND PRECAUTIONS
1. For non-professional self-testing use. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives
inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION
1. COVID-19 Test kit (Colloidal Gold Method) can be performed using nasal cavity sampling.
2. Testing should be performed immediately after specimen collection.
3. Bring specimens to room temperature prior to testing.
TEST PROCEDURE
Allow test cassette, specimen, and Antigen extract buffer control to equilibrate to room temperature (15-25°C)
prior to testing.Please wash and disinfect your hands before the test.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be
obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface.
Operation process:
1.Remove the secretions on the surface of the anterior nasal cavity, keep the head slightly tilted, and gently and
slowly insert the swab through the nasal cavity (about 2-4cm), Rotate gently 5 times, and gently rotate to remove
the swab.
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 extraction tube without touching the edge of
the tube, and add 6 drops (about 200ul) to the extraction tube.
3. Put the swab specimen into the 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.
5. Install the dripper on the extraction tube and cap it tightly, and let it stand for about 1 minute.
6. Open the aluminum foil bag and take out the test card, add 3 drops (about 100μl ) into the sample hole of the
test card (or use a pipette to add 100μl), and start the timer.
7. Wait for the colored line to appear. The result should be read in 15 minutes. Do not interpret the result after 20
minutes.
PROCEDURES AFTER RESULT INTERPRETATION
1. Use a household bleach spray or a 70%-75% alcohol spray to disinfect used product components.
2. Put used product components in a plastic bag. Close the bag and put it in another plastic bag. Dispose of the
bag in accordance with biohazard waste disposal methods.
3. Wash the hands thoroughly with soap or use hand sanitizer.
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
(SARS-CoV-2) antigen is detected in the specimen. The result is negative.
If the test result is negative:
Continue to follow all applicable rules regarding contact with others and protective measures.
Even if the test is negative, an infection may be present.
In case of suspicion, repeat the test after 1 - 2 days, because the Coronavirus cannot be accurately detected at
all stages of infection.
COVID-19 positive:
If the C and T band are present, the test indicates for the presence of COVID-19 (SARS-CoV-2) antigen in the
specimen. The result is COVID-19 positive.
There is currently a suspicion of a COVID-19 infection
• Contact physician/family physician or local health department immediately
• Follow local guidelines for self-isolation
• Have a PCR confirmatory test performed.
Look out for weak/faint line as positive, to follow up a positive result with a PCR test.
Refer to your relevant health authority for advice on whether a PCR test is required to confirm your result.
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.
In case of an invalid test result:
Possibly advance warning due to incorrect test performance.
Repeat the test.
If test results are still invalid, contact a physician or a COVID-19- Test Center.
LIMITATIONS
1. Use fresh samples whenever possible.
2. Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet.
Deviations may lead to aberrant results.
3. A negative result for an individual subject indicates absence of detectable COVID-19 (SARS-CoV-2) 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 (SARS-CoV-2) antigen present in the specimen is
below the detection limits of the assay, or failed to collect the COVID-19 (SARS-COV-2) antigen in the nasal
cavity of the patient.
5. The test kit provides a self-assessment. A conformed diagnosis should only be made by a physician after all
clinical and laboratory findings have been evaluated.
6. Only use for in vitro diagnostic, and cannot reused.
7. The antigen extract buffer is used to extract specimens, and shall not be used internal or external by humans
or animals. Swallowing will cause a serious accident. If happens, please seek medical attention immediately. The
antigen extract is irritating to eyes and skin, if splashed into eyes accidentally, please rinse with water soon. If
necessary, consult a doctor and maintain ventilation during the procedure.
8.This product is mainly used for self testing of aged 18-60. Usage for minors or seniors is recommended under
adults supervision.
PERFORMANCE CHARACTERISTICS
1.Clinical Sensitivity, Specificity and Accuracy
The results of the COVID-19 Test Kit（Colloidal Gold Method) were compared to results of RT-PCR assays for
SARS-CoV-2 in nasal swab specimens. A total of 499 nasal cavity 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 350 negative specimens and 149 positive specimens. The sensitivity
and specificity calculated were valid in this study.
Table 1： COVID-19 Test Kit vs PCR
Latest version 8.129.04.038-A7 Issued date: 2023-02-21
