The professional use COVID-19 Ag rapid test kit is designed to assist in the rapid diagnosis of SARS-COV-2 infection by detecting novel Coronavirus antigens in nasopharyngeal and oropharyngeal swabs using the dual-antibody sandwich method.

CE Certified COVID-19 Ag Rapid Test Kit

Description of COVID-19 Ag Rapid Test Kit

This test is limited to laboratories that are certified to perform medium, high complexity, or exempt complexity testing requirements. The test is authorized for use at Point of Care (POC), which are inpatient care facilities that have received CLIA exemption certificate, compliance certificate, or certification certificate. The test is to identify the SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of infection. A positive test result indicates the presence of viral antigens, but the correlation of clinical, medical history and other diagnostic information is necessary to determine infection status. However, bacterial infection or co-infection with other viruses can also cause a positive test result.

The test area (T) on theplain film has been pre-coated with an anti-2019-nCoV monoclonal antibody, forming a red reaction line in thearea (T). If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

Sensitivity: 96.15%

Specificity: 99.78%

Cross-reactivity: There is no cross-reactivity with influenza A virus, influenza B virus, adenovirus, Coxsackie virus, ECHO virus, and enterovirus; no cross-reactivity with Chlamydia pneumoniae, Mycoplasma pneumoniae, Chlamydia psittaci, and Chlamydia trachomatis; no cross-reactivity with Acinetobacter baumannii, Bordetella pertussis, Candida albicans, Escherichia coli, Haemophilus influenzae and Neisseria gonorrhea.

Application:

For suspected patients with symptoms, mild symptoms, or even asymptomatic patients, and also for those in close contact with infected persons and those under isolation and observation.

How to Use COVID-19 Ag Rapid Test Kit?

Collection of nasopharyngeal or oropharyngeal samples

1. After cleaning your hands, remove the nasopharyngeal swab and COVID-19 antigen test kit from the aluminum foil pouch.
2. Insert the nasopharyngeal swab into the nasopharynx, or insert the oropharyngeal swab into the oropharynx, gently rotate it 5 times and slowly remove it.

Extract Sample

1. Immediately after collecting the specimen, the swab was immersed in the sample extraction buffer.
2. The swab was repeatedly swirled against the wall of the tube for 10 seconds, then the swab was squeezed several times by holding the semi-solid tube with the fingers, and then the swab was slowly removed from the tube.
3. After removing and discarding the swab in the bio-waste container, tightly cap the sample extraction buffer, and then gently shake the pipette to mix the liquid in it.

Test Procedure

1. Invert the specimen extraction tube and hold it upright, squeeze the tube, and add more than 3 drops of sample solution (about 70-90 μL) to the test box through the nozzle of the tube.
2. Read the results after 15 minutes. The results after 30 minutes are invalid.

Interpretation of the Test Results

Positive: Both “T” and “C” sites have visible color lines.

Negative: Only the “C” site has color, “T” does not.

Invalid: If no color appears at the “C” site, the test result is invalid and the sample needs to be retested.

Limitations of Professional Use COVID-19 Ag Rapid Test Kit

1. This 2019-nCoV Ag rapid test kit is for the direct detection of the presence of SARS-CoV-2 antigen in respiratory specimens from patients suspected of covid-19.
2. This kit is a qualitative analysis, not a quantitative analysis.
3. The accuracy of the test depends on the sample collection process. Improper sample collection and storage can affect the test results.
4. The test results of this kit are for clinical reference only. A definitive diagnosis should only be made after all clinical and laboratory test results have been evaluated.
5. Due to the limitations of the antigen detection kit, it is recommended that negative test results be reviewed and confirmed using nucleic acid amplification or viral culture identification methods.
6. Positive test results do not exclude co-infection with other pathogens.

A negative result of this test kit can be caused by:

• Improper sample collection, improper sample transfer, or handing.
• The level of the SARS-CoV-2 virus is below the detection limit of the test.
• Variations in viral genes that may have caused changes in antigen determinants.

Precautions for 2019-nCoV Ag Rapid Self-Test Kit

1. The test results of this kit are for clinical reference only. A definitive diagnosis should only be made after all clinical and laboratory test results have been evaluated. It cannot be used as the only basis for treatment, patient management, and infection control. Negative test results should be considered based on the patient’s recent exposure history, medical history, and clinical signs and symptoms consistent with COVID-19. They should be confirmed by molecular testing for patient management if necessary.
2. COVID-19 Antigen Test Kit(Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures and proper infection control procedures and individuals similarly trained in point of care settings.
3. This kit is for the direct detection of the presence of SARS-CoV-2 antigen in respiratory specimens from patients suspected of covid-19.
4. This COVID-19 Ag rapid test kit is a qualitative analysis, not a quantitative analysis.
5. The accuracy of the test depends on the sample collection process. Improper sample collection and storage can affect the test results.
6. Due to the limitations of the antigen detection kit, it is recommended that negative test results be reviewed and confirmed using nucleic acid amplification or viral culture identification methods.
7. Positive test results do not exclude co-infection with other pathogens.

The COVID-19 Antigen Test is an in vitro immunochromatographic method for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from the saliva of individuals suspected of COVID-19.

Description of COVID-19 Antigen Rapid Test Kit

The test area (T) on the plain film has been pre-coated with an anti-2019-nCoV monoclonal antibody, forming a red reaction line in the area (T). If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

A positive test result indicates the presence of viral antigens, but the correlation of clinical, medical history, and other diagnostic information is necessary to determine infection status. However, bacterial infection or co-infection with other viruses can also cause a positive test result.

Sensitivity: 96.15%

Specificity: 99.78%

How to Use 2019-nCoV Ag Rapid Test Kit

1 ➜	2 ➜	3 ➜	4 ➜	5 ➜
Remove the cap of the extraction buffer	Connect the saliva collector to the extraction buffer tube	Cough deeply three times, and spit out saliva from the back of the oropharynx to the collector, saliva volume is up to the line	Remove the saliva collector	Return the cap

6 ➜	7 ➜	8 ➜	9 ➜	10
Shake the tube at least 1 min to mix the saliva and extraction buffer thoroughly	Break the pin on the top	Add 3~4 drops of the processed sample solution (about 80 μL) into the sample well	Wait 10-15 minutes	View the results

NOTE:

• Clean your hands before touching the tool.
• Do not eat for 30 minutes before collection.
• Rinse your mouth with water 30 minutes before saliva collection to clean up the residue.
• Pressing your tongue against the bases of your upper and lower teeth will help you spit out a sufficient amount of saliva in a short amount of time.
• The amount of saliva collected must reach the calibration line.
• Used collection tools should be disposed of in the dedicated clinical waste bin.

Interpretation of the Test Results

Positive Result:

If both C and T lines are visible within 15 minutes, the test result is positive and valid.

Negative Result:

If the test area (T line) has no color and the control area displays a colored line, the result is negative and valid.

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new test cassette.

NOTE:

• After the test kit is opened, the test should be carried out within 60 minutes.
• Read the result after 15 minutes. The interpretation is invalid for more than 30 minutes.
• When invalid results are presented, you should re-test with a COVID-19 antigen rapid test kit.

Cautions for Using COVID Ag Rapid Test Kit

• Since it cannot be ruled out that the patient is simply infected with the new coronavirus, a negative test result should be considered a presumptive result. The COVID-19 antigen rapid test kit cannot be used as the sole basis for treatment, patient management and infection control. A negative result should be considered based on the patient’s recent exposure, past medical history, and clinical signs and symptoms consistent with COVID-19. If necessary, it should be confirmed by molecular testing in patient management.
• This covid test kit is only used for in vitro auxiliary diagnosis and should be used strictly by the Instructions For Use.
• Please check the expiry date and packaging integrity of the kit before use. If the packaging of the test equipment is damaged or the product is out of date, it cannot be used.
• Due to the limitations of antigen detection kits, it is recommended to use nucleic acid amplification or virus culture identification methods to review and confirm negative test results.
• The kit is stored at 4℃~30℃. Keep away from moist, sunlight, heat, or freezing conditions.
• The test results of this kit are for clinical reference only, and clinical diagnosis should be considered in combination with the patient’s symptoms, signs, medical history, other laboratory tests and treatment response.
• The test results of this COVID-19 antigen rapid test kit are only for clinical reference, and the clinical diagnosis of the disease should be considered in combination with the patient’s symptoms, signs, medical history, other laboratory tests, and treatment response.

Saliva-based tests are especially convenient compared to nasal or oropharyngeal swabs making it easier for people to self-test.

Description of COVID-19 Antigen Rapid Test Kit

The test is to identify the SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of infection. A positive test result indicates the presence of viral antigens, but the correlation of clinical, medical history, and other diagnostic information is necessary to determine infection status. However, bacterial infection or co-infection with other viruses can also cause a positive test result.

If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

Instructions for Use COVID-19 Ag Rapid Test Kit

NOTE:

1. Clean your hands before touching the tool.
2. Do not eat for 30 minutes before collection.
3. Take the sample buffer and test cassette to equilibrate to room temperature.
4. Rinse your mouth with water 30 minutes before saliva collection to clean up the residue.
5. Pressing your tongue against the bases of your upper and lower teeth will help you spit out a sufficient amount of saliva in a short amount of time.
6. The amount of saliva collected must reach the calibration line.
7. Used collection tools should be disposed of in the dedicated clinical waste bin.

Interpretation of the Test Results

Positive Result:

If both C and T lines are visible within 15 minutes, the test result is positive and valid.

Negative Result:

If the test area (T line) has no color and the control area displays a colored line, the result is negative and valid.

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new test cassette.

NOTE:

• Read the result after 15 minutes.
• The interpretation is invalid for more than 30 minutes.
• Specimens containing very low levels of target antibodies may develop two colored lines over 15 minutes.
• When invalid results are presented, you should re-test with a new tool.

Cautions of COVID-19 Antigen Rapid Test Kit

• This test kit is a qualitative assay, not a quantitative assay.
• The accuracy of the test depends on the sample collection process. Improper sample collection, improper sample storage will affect the test result.
• It cannot be used as the only basis for treatment, patient management, and infection control. Negative test results should be considered based on the patient’s recent exposure history, medical history, and clinical signs and symptoms consistent with COVID-19.
• This kit is only used for in vitro auxiliary diagnosis and should be used strictly by the Instructions For Use.
• Please check the kit’s effective date and package integrity before use. The test equipment cannot be used if its packaging is damaged or the product is outdated.
• The time for testing and results reading must be followed.
• After the pouch of the test cassette is opened, the test should be performed within 60 min. The test cassette can only be used once.
• Due to the limitations of antigen detection test kits, it is recommended to use nucleic acid amplification or virus culture identification methods to review and confirm negative test results.
• The kit is stored at 2℃~30℃. Keep away from moist, sunlight, heat, or freezing conditions.
• The test results of this kit are only for clinical reference, and the clinical diagnosis of the disease should be considered in combination with the patient’s symptoms, signs, medical history, other laboratory tests, and treatment response.

The reagent membrane on the 2019-nCoV ag lollipop rapid test kit contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus. The reaction membrane contains the secondary antibodies for Novel coronavirus, and the polyclonal antibodies against the mouse globulin, which are preimmobolized on the membrane.

Guide 1 for 2019-nCoV lollipop rapid saliva test

1. After washing your hands, take the test kit out of the aluminum foil bag and remove the blue lid of the test lollipop.
2. Lower the tip of the tongue and the upper jaw of the mouth and wait for the saliva to fill the mouth, put the absorbent tip of the best lollipop into the mouth (all the absorbent tip is pressed under the tongue), and place the absorbent tip beneath the tongue for 90 seconds.
3. Take out the test lollipop from the mouth and lid the blue of the test lollipop. Place the test lollipop horizontally, read the displayed result within 15 minutes, and the results read after 30 minutes are invalid.
4. Safely throw away the waste into a biohazard container.

Guide 2 for COVID-19 lollipop rapid saliva test kit

1. Spit saliva to the saliva collector.
2. Take out the test lollipop, put the saliva adsorption stick into the saliva collector, start the timer. After about 90 seconds, cover the lid of the saliva adsorption stick.
3. Pace the detection lollipop horizontally on the workbench, and read the detection result 15 minutes later.The test result should not be read and interpreted after 30 minutes.
4. Safely throw away the waste into biohazard containers.

Interpretation of Results

This kit collects saliva samples from the saliva adsorption stick at the front of the test card, if the sample contains a SARS-CoV-2 N protein antigen, it is identified and bound by antibodies labeled on the surface to form an immune complex.

Positive:

Two colored lines appear. One red-colored line next to “C” and one red-colored line next to “T” indicates SARSCoV-2 positive result.

Negative:

One red-colored line only next to “C” indicates a negative result.

Invalid:

If the red-colored line in the control region “C” is not visible, the result is invalid.

Precautions for using lollipop rapid saliva test kit

1. For in vitro diagnostic use only.
2. Allow the test device to equilibrate to room temperature (25℃-30℃) prior to testing.
3. Do not eat, drink, or smoke for at least 30 minutes before the test.
4. Do not use it after the expiration date.
5. Ensurefoilpouchcontaining test device is not damaged before opening for use.
6. Perform the test at room temperature from 15℃ to 30℃.
7. Wear gloves when hanging the samples, and avoid touching the reagent, embrace and sample window.
8. All samples and used accessories should be treated as infectious and discarded according to local regulations.
9. Avoid using blood samples.
10. Antigen detection cannot be used alone to diagnose SARS-CoV-2 infection, and the infection status should be determined in combination with nucleic acid detection, imaging, and other diagnostic information, as well as medical history and contact history.

Features of Micro-droplet Digital PCR Test Kit

Monkeypox virus nucleic acid detection kit (PCR), with high sensitivity and good specificity, can quickly and accurately identify monkeypox virus by specifically detecting the gene fragments of monkeypox virus, and the test results can be obtained in a short time, which helps the accurate diagnosis and prevention of monkeypox virus.

1. The specificity and sensitivity have been significantly improved. 
2. The absolute quantification index can be obtained directly without relying on internal reference and standard curve. 
3. The microreaction units are independent and closed to each other, avoiding mutual interference between PCR inhibitors and amplification products of different nucleic acid molecules, with higher accuracy and reproducibility. 

Description of Monkeypox Rapid Test Kit

A minimum quantification limit of 5 copies/μl can be achieved with this monkeypox virus micro-droplet digital PCR test kit. 
A: Quantification result of 5 copies/μl for surface positive samples. 
B: Fluorescence photograph of droplet generation of positive samples with good droplet generation. 
C: 1D scatter plot of the positive sample. The positive signal is well separated from the negative signal, and there is no rain-drop effect. 

The monkeypox virus micro-droplet digital PCR test kit is also compatible for use with common fluorescence quantitative PCR instruments, achieving a minimum quantification limit of 50 copies/μl on the ABI7500 fluorescence quantitative PCR.

Cat. No. List

REF No.	CY-MNA-24	CY-MNA-48	CY-MNA-96	CY-MNA-480	CY-MNA-960
Reaction buffer A	459 μl/tube (1tube)	918 μl/tube (1tube)	918 μl/tube (1tube)	4590 μl/tube (2tubes)	4590 μl/tube (4tubes)
Reaction buffer B	102 μl/tube (1tube)	204 μl/tube (1tube)	204 μl/tube (2tubes)	1020 μl/tube (2tubes)	1020 μl/tube (4tubes)
Positive control	20 μl/tube (1tube)	40 μl/tube (1tube)	80 μl/tube (1tube)	200 μl/tube (2tubes)	200 μl/tube (4tubes)
Negative control	20 μl/tube (1tube)	40 μl/tube (1tube)	80 μl/tube (1tube)	200 μl/tube (2tubes)	200 μl/tube (4tubes)