COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

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The COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocap- sid antigens in nasal swab from individuals who are suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasal swab during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or  co-infection  with  other  viruses.  The   agent   detected   may   not   be the definite cause of disease.

Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular      assay,      if      necessary      for      patient      management.  This kit are for home use by laymen in a non-laboratory setting(such as person’s home or certain non-traditional sites such as offices,sporting events, schools etc.). The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patients clinical manifestations and other laboratory tests.


The novel coronaviruses (SARS-CoV-2) 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; asymptomatic 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.


The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugat- ed with color microparticles is used as detector and sprayed on conjugation pad. During the test, SARS-CoV-2 antigen in the specimen interacts with SARS-CoV-2 antibody conjugated with color microparticles making antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coat- ed SARS-CoV-2 nucleocapsid protein monoclonal antibody. A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens are present in the specimen. Absence of the T line suggests a negative result. The control    line    (C)    is     used     for     procedural     control,     and     should always appear if the test procedure is performed properly.


•For Self testing in vitro diagnostic use only.This tset cassette is for one-time use and cannot be reused or used by multiple people.

•Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19.

•Please read all the information in this leaflet before performing the test.

•Do not use this product after the expiration date.

•The test cassette should remain in the sealed pouch until use.

•All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

•Test for children and young people should be used with an adult.

•The used test cassette should be discarded according to federal, state and local regulations.

•Do not use the test on children under 2 years old.

•Small children should be swabbed with the help of a second adult.

•Wash hands thoroughly before and after handling.


Materials Provided

•Test Cassettes: each cassette with desiccant in individual foil pouch

•Prepackaged Extraction Reagents:

•Sterilized Swabs: single use sterile swab for specimen collection

•Package Insert

Materials Required but not Provided



•Store as packaged in the sealed pouch at temperature (4-30℃ or 40-86℉). The  kit  is  stable  within  the  expiration  date  printed  on  the  labeling.

•Once open the pouch, the test should be used within one hour. Prolonged exposure  to  hot  and  humid  environment  will  cause  product deterioration.



Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield false results; therefore, training in specimen collection is highly recommended due to the importance of specimen quality to obtain accurate test results. Acceptable specimen type for testing is a direct nasal swab specimen obtained by the dual nares collection method. Prepare the extraction tube according to the Test Procedure and use the sterile swab provided in the kit for specimen collection.

Nasal Swab Specimen Collection


1.Remove the swab from the package.

2.Tilt patient's head back about 70°.

3.1-2While gently rotating the swab, insert swab about 2.5 cm (1 inch) into nostril until resistance is met at turbinates.

4.Rotate the swab several times against nasal wall and repeat in other nostril using the same swab.

Specimen Transport and Storage

Do not return the swab to the original swab packaging. Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection.


Note: Allow the test cassettes, reagents and specimens to equilibrate to room temperature (15-30℃ or 59-86℉) prior to testing.

1.Place the extraction tube in the workstation.

2.Peel off aluminum foil seal from the top of the extraction tube containing the extraction tube containing the extraction buffer.

3.Sampling refers to section ‘Specimen Collection’.

4.Insert the nasal swab specimen into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube. Leave the nasal swab in the extraction tube for one minute.

5.Remove the nasal swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test sample. 6.Cover the extraction tube with a dropper tip tightly.


7.Remove the test cassette from the sealed pouch.

8.Reverse the specimen extraction tube, holding the tube upright, transfer 3 drops (approximately 100 μL) slowly to the specimen well (S) of the test cassette, then start the timer.

9.Wait for colored lines to appear. Interpret the test results at 15 minutes. Do not read results after 20 minutes.



 Positive C T C T  Two lines appear. One colored line appears of the intensity of the test line.
 Negative   C T  One colored line appears at the control region (C), and no line appears at the test region (T).



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 using a new test cassette. If the problem persists,    discontinue    using    the    lot    immediately and contact your local distributor.


A procedural control is included in the test. A colored line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.


•The product is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antigen of the specimens.

•Negative results do not preclude SARS-CoV-2 infection and if symptoms are present you must seek immediate further testing Via the PCR Method.

•A physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.

•A negative result obtained from this Kit should be confirmed by PCR. A negative result can occur if the quantity of SARS-CoV-2 antigens present in the specimen is below the detection threshold of the assay, or the virus has undergone minor amino acid mutation(s) in the target epitope region recognized by the monoclonal antibodies utilized in the test.

•Excess blood or mucus on the swab specimen may interfere with performance and may yield false positive result.


Clinical Performance

A procedural control is included in the test. A colored line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

COVID-19 antigen RT-PCR Totale
Positive Negative


Positive 212 0 212
Negative 3 569 572
Total 215 569 784

PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%)

PPA - Positive Percent Agreement (Sensitivity) NPA - Negative Percent Agreement (Specificity) 95% *Confidence Intervals

Days since symptom RT-PCR HEO TECHNOLOGY Agreement(%)
0-3 95 92 96.84%
4-7 120 120 100%
Ct≤30 42 42 100%
Ct≤32 78 78 100%
Ct≤35 86 85 98.84%
<37 9 7 77.78%

Limit of Detection (Analytical Sensitivity)

The study used cultured SARS-CoV-2 virus , which is heat inactivated and spiked into nasal swab specimen. The Limit of Detection (LoD) is 1.0 ×102 TCID50/mL.

Cross Reactivity (Analytical Specificity)

Cross reactivity was evaluated by testing 32 commensal and pathogenic microorganisms    that    may    be    present     in     the     nasal     cavity.     No cross-reactivity was observed with recombinant MERS-CoV NP protein when tested at the concentration of 50 pg/mL.

No cross-reactivity was observed with the following viruses when tested at the concentration of 1.0×106 PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H7N9), Influenza A (H3N2), Influenza B (Yamagata), Influenza B (Victoria), Adenovirus (type 1, 2, 3, 5, 7, 55), Human metapneumovirus,

Parainfluenza virus (type 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

No cross-reactivity was observed with the following bacteria when tested at the concentration of 1.0×107 CFU/mL: Mycoplasma pneumoniae, Chlamy- dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococ- cus pyogenes (group A), Streptococcus pneumoniae, Candida albicans Staphylococcus aureus.


The following potential interference substances were evaluated with the COVID-19 Antigen Rapid Test Cassette (Nasal Swab) at the concentrations listed below and were found not to affect test performance.


Substance Concentration Substance Concentration
Mucin 2% Whole blood 4%
Benzocaine 5 mg/mL Menthol 10 mg/mL
Saline nasal spray 15% Phenylephrine 15%
Oxymetazoline 15% Mupirocin 10 mg/mL
Tobramycin 5 μg/mL Zanamivir 5 mg/mL
Oseltamivir phosphate 10 mg/mL Ribavirin 5 mg/mL
Arbidol 5 mg/mL Dexamethasone 5 mg/mL
Fluticasone propionate 5% Histamine


10 mg/mL
Triamcinolone 10 mg/mL

High-dose Hook Effect

The COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) was tested up to 1.0×10 5 TCID50 /mL of inactivated SARS-CoV-2 and no high-dose hook effect was observed.

Frequently Asked Question

1.How does the SARS-CoV-2  Antigen Rapid Test work? The test is for the qualitative detection of SARS-CoV-2 antigens in self-col- lected  swab  specimens.  A  positive  result  indicates   SARS-CoV-2 antigens present in the specimen.

When should the test be used?

SARS-CoV-2 antigen can be detected in acute respiratory tract infection, it is recommended to run the test when symptoms including sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia.

Can the result be incorrect?

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if inadequate sampling volume or the SARS-CoV-2 Antigen Rapid Test gets wet before test performing, or if the number of extraction buffer drops are less than 3 or more than 4. Besides, due to immunological principles involved, there exist the chances of false results in rare cases. A consultation with the doctor is always recommended for such tests based on immunological principles.

How to interpret the test if the color and the intensity of the lines are different? The color and intensity of the lines have no importance for result interpreta- tion. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the color intensity of the test line is. 5.What do I have to do if the result is negative?

A negative result means that you are negative or that the viral load is too low

to berecognized by the test. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even  though the test is negative.

If you experience symptoms such as headaches, migraines, fever, loss of sense of smell and taste, contact the nearest medical facility using the rules of your local authority. In addition, you can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of an infection. Distance and hygiene rules must still be observed. Even with a negative test result, distance and hygiene rules must be observed, migration/traveling, attending events and etc. should follow your local COVID guidelines/requirements. 6.What do I have to do if the result is positive?

A positive result means the presence of SARS-CoV-2 antigens. A positive results means it is very likely you have COVID-19. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner / doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.


Weiss SR,Leibowitz JZ. Coronavirus pathogensis, Adv Virus Res 2011;81:85-164

Cui J, li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019;17:181-192

Su S,Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronavirues. TrendsMicrobiol 2016;24:4900502.



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