INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test Instruction Manual

INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test

SARS-CoV-2 Antigen Rapid Qualitative Test

Instructions for Use
For prescription only
For in vitro diagnostic use only
Please read these instructions completely before beginning testing of specimens.

INTENDED USE

The SARS-CoV-2 Antigen Rapid Qualitative Test is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasal swabs or throat swabs from individuals who are suspected of COVID-19 by their healthcare provider. within the first five days of the onset of symptoms. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in upper respiratory samples or lower respiratory samples 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. The SARS-CoV-2 Antigen Rapid Qualitative Test 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.

SUMMARY

SARS-CoV-2 belongs to the broad family of viruses known as coronaviruses. It is a positive-sense single-stranded RNA (+ssRNA) virus. Other coronaviruses are capable of causing illnesses ranging from the common cold to more severe diseases such as Middle East respiratory syndrome(MERS). It is the seventh known coronavirus to infect people, after 229E, NL63, OC43, HKU1, MERS-CoV, and the original SARS-CoV. Protein modeling experiments on the spike (S) protein of the virus suggest that it has sufficient affinity to the angiotensin converting enzyme 2 (ACE2) receptors of human cells to use them as a mechanism of cell entry. Studies have shown that SARS-CoV-2 has a higher affinity to human ACE2 than the original SARS virus strain. SARS-CoV-2 infections cause COVID-19 disease. People who have confirmed COVID-19 have a range of symptoms, from people with little to no symptoms to people being severely sick and dying. Symptoms can include: fever, tiredness, and dry cough.. Some patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. Some people become infected but don’t develop any symptoms and don’t feel unwell. Most people (about 80%) recover from the disease without needing special treatment. Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. About 2% of people with the disease have died. People with fever, cough and difficulty breathing should seek medical attention. Human-to-human transmission of the virus has been confirmed and occurs primarily via respiratory droplets from coughs and sneezes within a range of about 6 feet (1.8m). Viral RNA has also been found in stool specimens from infected patients. It is possible that the virus can be infectious even during the incubation period, but this has not been proven, and the WHO stated on 1 February 2020 that “transmission from asymptomatic cases is likely not a major driver of transmission” at this time. The median incubation time is estimated to be approximately 5 days with symptoms estimated to be present within 12 days of infection.3 The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever, cough, shortness of breath.

PRINCIPLES OF THE PROCEDURE

This reagent is based on colloidal gold immunochromatography assay.
During the test, specimen extracts are applied to the test cartridges. If there were SARS-CoV-2 antigen in the extract, the antigen will bind to the SARS-CoV-2 monoclonal antibody. During lateral flow, the complex will move along the nitrocellulose membrane toward the end of the absorbent paper. When passing the test line (line T, coated with another SARS-CoV-2 monoclonal antibody) the complex is captured by SARS-CoV-2 antibody on test line resulting in coloring on line T; when passing the line C, colloidal gold- labeled goat anti-rabbit IgG is captured by control line (line C, coated with rabbit IgG) resulting in coloring on line C.

REAGENTS

The following components are included in the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 kit

Materials Provided:

25-Test Kit:

1. SARS-CoV-2 Antigen Test Cartridge (25): Monoclonal anti-SARS antibodies
2. Extraction Tubes (25)
3. Extraction solution: 2 bottles/kit (enough for 25 test)
4. Instructions for use 1 copy/kit
5. QC Card (located on kit box)

Optional Materials:

1. Throat Swabs (25)
2. Nasal Swabs (25)

Materials Required but not provided:

1. Timer
2. Tube rack for specimens
3. Any necessary personal protective equipment
4. External control set (including 1negative controls and 1 positive controls).

WARNINGS AND PRECAUTIONS

1. For in vitro diagnostic use.
2. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
3. Do not use this kit beyond the expiration date printed on the outside carton.
4. Do not use the kit to evaluate patient specimens if either the positive control swab or negative control swab fail to give expected results.
5. Test results are meant to be visually determined.
6. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section.
7. Do not reuse any kit components.
8. When collecting a nasal swab sample, use the nasal swab supplied in the kit. Use of alternative swabs may result in false negative results.
9. Proper specimen collection, storage and transport are critical to the performance of this test.
10. Specific training or guidance is recommended if operators are not experienced with specimen collection and handling procedures. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. Standard precautions and institutional guidelines should always be followed in handling, storing, and disposing of all specimens and all items contaminated with blood or other body fluids.
11.  The SARS-CoV-2 external positive control have been prepared from recombinant viral proteins and do not contain infectious material.
12. Dispose of used test kits as biohazardous waste in accordance with federal, state and local requirements.
13. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) located at bd.com.
14. Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.

STORAGE CONDITIONS & PERIOD OF VALIDITY

1. Store extraction solution at 2-30℃, the shelf life is 24 months tentatively.
2. Store the test cartridge at 2-30℃, the shelf life is 24months tentatively.
3. Test Cartridge should be used right after opening the pouch.

Reagents and devices must be at room temperature (15–30 °C) when used for testing.

SPECIMEN COLLECTION AND HANDING

Specimen Collection and Preparation

• Throat Swab Specimen Collection:
  Let the patient’s head tilt slightly, mouth open, and make “ah” sounds, exposing the pharyngeal tonsils on both sides. Hold the swab and wipe the pharyngeal tonsils on both sides of the patient with moderate force back and forth for at least 3 times.

• Nasal Swab Specimen Collection:

1. Insert the swab into one nostril of the patient. The swab tip should be inserted up to 2.5 cm (1 inch) from the edge of the nostril.
2.  Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected
3. Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal cavities. Withdraw the swab from the nasal cavity.  

Specimen Transport and Storage:
Samples should be tested as soon as possible after collection. Based on data generated with influenza virus, throat swabs are stable for up to 24-hours at room temperature or 2° to 8°C.

TEST METHODS

The test should be operated at room temperature（15-30℃）.

1. Place the extraction tube with opening facing up. Press the extraction solution bottle to drip 6 drops of extract solution into the extractor tube without touching the edge of the tube.
2. The extraction of specimen: Put the swab had collected specimen into the extraction tube, hold and press the swab head against the wall of tube with force while rotating the swab for about 10 seconds to release the antigen into the extraction solution from the swab head.
3. Removing swab: Squeeze the swab head while removing the swab in order to remove as much liquid as possible from the swab. Dispose of swabs according to biohazard waste disposal regulations.
4. Install the nozzle cap onto the extraction tube.
5. Loading: drip 2 drops of extraction solution into the sample well of the test cartridge, and start the timer.
6. Read the results at 20~30 minutes. Strong positive results can be reported at 20 minutes, however, negative results must be reported after 30 minutes. If positive signal appears after 30 minutes, it should not be reported as positive.

• Drip extract solution

• Extraction

• Removing swab

• Install the nozzle

• Loading

• Reading

INTERPRETATION OF TEST RESULTS

Line C must be colored to have a valid test result.
Valid results:
Negative result: There is coloration on line C only showing as following picture, suggesting that there is no SARS-CoV-2 antigen in the specimen.
Positive result: There are coloration on both line C and line T showing as follow pictures, suggesting that there is SARS-CoV-2 antigen in the specimen.
Invalid result: There is no coloration on line C, as shown in the following pictures. The test is invalid or an error in operation occurred. Repeat the assay with a new cartridge.

REPORTING OF RESULTS

• Positive Test:
  Positive for the presence of SARS-CoV-2 antigen. 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

• Negative Test :
  Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the presence of clinical signs and symptoms consistent with COVID-19, or in those who have been in contact with the virus. It is recommended that these results be confirmed by a molecular testing method, if necessary, for patient management Control.

• Invalid:
  Do not report results. Repeat the test.

QUALITY CONTROL

The SARS CoV-2 Antigen Control Set (catalog number: 1339) is available to purchase separately from Xiamen Biotime Biotechnology Co., Ltd as external controls. The control set can be ordered through website (www.biotime.cn), telephone (+86-592-6883156) and email (baotai@biotime.cn). One negative and one positive control are included in the control set. Returning expected test results for each control in the control set indicates appropriate performance of SARS-CoV-2 Antigen Rapid Qualitative Test. If any control of the control set fail to provide the expected result, reasons that have led to failure including the test kit, the operator, the environment, the test procedure and any other causes which may affect the test result should be analyzed and corrective action taken. Clinical specimens can be run in the Biotime SARS- CoV-2 Antigen Rapid Qualitative Test. If all the control set results observed are the expected results. Please refer to the Instructions For Use of Biotime SARS-CoV-2 Antigen Control Set for expected test results as well as other information. It is recommended that the controls are tested when:

• A new operator uses the kit;
• A new lot of test kits is used;
• A new shipment of kits is used;
•  The temperature used during storage of the kit falls outside of the recommended conditions;
• The temperature of the test area falls outside of 15-30°C;
• To verify a higher than expected frequency of positive or negative results;
•  To investigate the cause of repeated invalid results; or
• A new test environment is used (e.g., natural light vs. artificial light).
• As required by external quality control procedures and in accordance with local, state and federal regulations or accreditation requirements.

NOTE: Prepare kit control swabs and test using the same procedure as used for patient specimens. Failure of the external/procedural controls will generate an invalid test result.
If the kit controls do not perform as expected, do not report patient results. Contact Xiamen Biotime Biotechnology Co., Ltd Technical Services at (+86-592-6883577) and email (baotai@biotime.cn).

LIMITATIONS OF THE PROCEDURE

1. Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples.
2. Users should test specimens as quickly as possible after specimen collection.
3. Positive test results do not rule out co-infections with other pathogens.
4. Results from SARS-CoV-2 Antigen Rapid Qualitative Test should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
5. A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
6. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5 of illness are more likely to be negative compared to a RT-PCR assay.
7. Failure to follow the test procedure may adversely affect test performance and/or invalidate the test result.
8. The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 antigens from throat or nasal swab specimens only.
9. The kits for rapid detection of SARS-Cov-2 can detect both viable and non-viable SARS-CoV-2 material. The SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 performance depends on antigen load and may not correlate with other diagnostic methods performed on the same specimen.
10.  Negative test results are not intended to rule in other non-SARS-CoV-2 viral or bacterial infections.
11. Positive and negative predictive values are highly dependent on prevalence rates. Positive test results are more likely to represent false positive results during periods of little/no SARS-CoV-2 activity when disease prevalence is low. False negative test results are more likely when prevalence of disease caused by SARS-CoV-2 is high.
12. This device has been evaluated for use with human specimen material only.
13. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region.
14.  The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals.
15.  Sensitivity of the test after the first five days of the onset of symptoms has been demonstrated to decrease as compared to a RT-PCR SARS-CoV-2 assay.
16. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results.
17.  Specimen stability recommendations are based upon stability data from influenza testing and performance may be different with SARS-CoV-2. Users should test specimens as quickly as possible after specimen collection, and within one hour after specimen collection.
18. The validity of SARS-CoV-2 Antigen Rapid Qualitative Test has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity.

CLINICAL PERFORMANCE

The performance of the Biotime SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 was established with 295 direct nasal swab or throat swab prospectively collected and enrolled from individual symptomatic patients (within 5 days of onset) who were spected of COVID-19. As with all antigen tests, performance may decrease as days since symptom onset increases. For each type, four kinds of samples from the same person were tested by Company’s Kit. We selected 25 positive and 25 negative sample. P1-P25 of samples are from infected people, and NI-N25 are from uninfected people. P21-P25 are weekly positive.

Method| PCR Test|

Total Results

|
---|---|---|---

Biotime Results

|

Results

|

positive

|

Negative

|
positive| 72| 0| 72|
Negative| 3| 220| 223|
| Relative Sensitivity:                  72/75| 96.00% (88.75%～99.17%)|
| Relative Specificity:                 220/220| 100.00% (98.34%～100.00%)|
| Accuracy:                                  292/295| 98.98% (97.06%～99.79%)|
| Total Results| 75| 220| 295

ANALYTICAL PERFORMANCE

LIMIT OF DETECTION (ANALYTICAL SENSITIVITY)

LOD of human sputum matrix

The LOD for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 antigen (bei Resources NR-52286). The material was supplied frozen at a concentration of TCID50 of 3.40 x105 per mL.
In this study, designed to estimate the LOD of the assay when using a direct throat swab, the starting material was spiked into a volume of pooled human sputum obtained from healthy donors and confirmed negative for SARS-CoV-2. An initial range finding study was performed testing devices in triplicate using a 10-fold dilution series of 3 replicates per concentration. At each dilution, 50 µL samples were added to swabs and then tested in the assay using the procedure appropriate for patient throat swab specimens. A concentration was chosen between the last dilution to give 3 positive results and the first to give 3 negative results. Using this concentration, the LOD was further refined with a 2-fold dilution series of 3 replicates per concentration. The last dilution demonstrating 100% positivity was then tested in an additional 20 replicates tested in the same way.

Starting Material Concentration| Estimated LOD|

No. Positive/Total

|

% Positive

---|---|---|---
3.40 x 105 TCID50/mL| 4.25 x 10² TCID50/mL| 19/20| 95%

LOD of human nasal swab specimen matrix

The LOD for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 (bei Resources NR-52286). The material was supplied frozen at a concentration of TCID50 of 3.40 x105 per mL.
In this study, designed to estimate the LOD of the assay when using a direct throat swab, the starting material was spiked into a volume of pooled human nasal swab specimen obtained from healthy donors and confirmed negative for SARS-CoV-2. An initial range finding study was performed testing devices in triplicate using a 10-fold dilution series of 3 replicates per concentration. At each dilution, 50 µL samples were added to swabs and then tested in the assay using the procedure appropriate for patient nasal swab specimens. A concentration was chosen between the last dilution to give 3 positive results and the first to give 3 negative results. Using this concentration, the LOD was further refined with a 2-fold dilution series of 3 replicates per concentration. The last dilution demonstrating 100% positivity was then tested in an additional 20 replicates tested in the same way.

Starting Material Concentration| Estimated LOD| No. Positive/Total| % Positive
---|---|---|---
3.40 x 105 TCID50/mL| 3.40 x 102 TCID50/mL| 19/20| 95%

CROSS REACTIVITY (ANALYTICAL SPECIFICITY)

Human sputum matrix

Cross-reactivity of the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 was evaluated by testing a panel of high prevalence respiratory pathogens that could potentially cross-react with the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2. Each organism and virus spiked into negative throat specimen was wet-tested in triplicate. The final concentration of each organism is documented in the following table

S.N.

| Potential Cross-Reactant| Concentration Tested| Cross- Reactivity (Yes/No)
---|---|---|---
1| Human coronavirus 229E| 2.0 x 105 TCID50/mL| NO
2| Human coronavirus OC43| 2.0 x 105 TCID50/mL| NO
3| Human coronavirus NL63| 2.0 x 105 TCID50/mL| NO
4| SARS-coronavirus| 2.0 x 105 TCID50/mL| NO
5| MERS-coronavirus| 2.0 x 105 TCID50/mL| NO
6| Human coronavirus HKU1| 2.0 x 105 TCID50/mL| NO
7| Adenovirus C1| 2.0 x 105 TCID50/mL| NO
8| Adenovirus 71| 2.0 x 105 TCID50/mL| NO
9| Human Metapneumovirus (hMPV)| 2.0 x 105 TCID50/mL|

NO

10| Parainfluenza virus 1-4| 2.0 x 105 TCID50/mL| NO
11| Influenza A| 2.0 x 105 TCID50/mL| NO
12| Influenza B| 2.0 x 105 TCID50/mL| NO
13| Enterovirus| 2.0 x 105 TCID50/mL| NO
14| Respiratory syncytial virus| 2.0 x 105 TCID50/mL| NO
15| Rhinovirus| 2.0 x 105 TCID50/mL| NO
16| Haemophilus influenzae| 2.0 x 106 TCID50/mL| NO
17| Streptococcus pneumoniae| 2.0 x 106 TCID50/mL| NO
18| Streptococcus pyogenes| 2.0 x 106 TCID50/mL| NO
19| Candida albicans| 2.0 x 106 TCID50/mL| NO
S.N.| Potential Cross-Reactant| Concentration Tested| Cross- Reactivity (Yes/No)

20

| Pooled human nasal wash – representative of normal
respiratory microbial flora| 2.0 x 106 TCID50/mL| NO
21| Bordetella pertussis| 2.0 x 106 TCID50/mL| NO
22| Mycoplasma pneumoniae| 2.0 x 106 TCID50/mL| NO
23| Chlamydia pneumoniae| 2.0 x 106 TCID50/mL| NO
24| Legionella pneumophila| 2.0 x 106 TCID50/mL| NO
25| Mycobacterium tuberculosis| 2.0 x 106 TCID50/mL| NO
26| Pneumocystis jirovecii (PJP)| 2.0 x 106 TCID50/mL| NO

Note :1 TCID50/mL≈0.7CFU/ml
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen Rapid Qualitative Test do not cross-react.

Human nasal swab specimen matrix

Cross-reactivity of the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 was evaluated by testing a panel of high prevalence respiratory pathogens that could potentially cross-react with the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2. Each organism and virus spiked into negative nasal specimen was wet-tested in triplicate. The final concentration of each organism is documented in the following table.

S.N.

|

Potential Cross-Reactant

|

Concentration Tested

| Cross- Reactivity (Yes/No)
---|---|---|---
1| Human coronavirus 229E| 2.0 x 105 TCID50/mL| NO
2| Human coronavirus OC43| 2.0 x 105 TCID50/mL| NO
3| Human coronavirus NL63| 2.0 x 105 TCID50/mL| NO
4| SARS-coronavirus| 2.0 x 105 TCID50/mL| NO
5| MERS-coronavirus| 2.0 x 105 TCID50/mL| NO
6| Human coronavirus HKU1| 2.0 x 105 TCID50/mL| NO
7| Adenovirus C1| 2.0 x 105 TCID50/mL| NO
8| Adenovirus 71| 2.0 x 105 TCID50/mL| NO

9

| Human Metapneumovirus (hMPV)|

2.0 x 105 TCID50/mL

|

NO

10| Parainfluenza virus 1-4| 2.0 x 105 TCID50/mL| NO
11| Influenza A| 2.0 x 105 TCID50/mL| NO
12| Influenza B| 2.0 x 105 TCID50/mL| NO
13| Enterovirus| 2.0 x 105 TCID50/mL| NO
14| Respiratory syncytial virus| 2.0 x 105 TCID50/mL| NO
15| Rhinovirus| 2.0 x 105 TCID50/mL| NO
16| Haemophilus influenzae| 2.0 x 106 TCID50/mL| NO
17| Streptococcus pneumoniae| 2.0 x 106 TCID50/mL| NO
18| Streptococcus pyogenes| 2.0 x 106 TCID50/mL| NO
19| Candida albicans| 2.0 x 106 TCID50/mL| NO

20

| Pooled human nasal wash – representative of normal
respiratory microbial flora| 2.0 x 106 TCID50/mL|

NO

21| Bordetella pertussis| 2.0 x 106 TCID50/mL| NO
22| Mycoplasma pneumoniae| 2.0 x 106 TCID50/mL| NO
23| Chlamydia pneumoniae| 2.0 x 106 TCID50/mL| NO
24| Legionella pneumophila| 2.0 x 106 TCID50/mL| NO
25| Mycobacterium tuberculosis| 2.0 x 106 TCID50/mL| NO
26| Pneumocystis jirovecii (PJP)| 2.0 x 106 TCID50/mL| NO

Note :1 TCID50/mL≈0.7CFU/ml
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen Rapid Qualitative Test do not cross-react.

MICROBIAL INTERFERENCE STUDIES

Human sputum matrix

The microbial interference studies for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 (bei Resources NR-52286).
The material was supplied frozen at a concentration of TCID50 of 3.40 x105 per mL. the starting material was spiked into a volume of pooled human sputum (the most challenging respiratory matrix) obtained from healthy donors and confirmed negative for SARS-CoV- Based on the LOD studies, a low (3x LoD) SARS-CoV-2 concentration of 1.275x 103 TCID50/mL was chosen. The specimen was confirmed positive for SARS-CoV-2 with faintly line on Line T. Furthermore, the above-mentioned specimen was divided into  30.Finally, the microorganism indicated below was respectively spiked into the divided specimen to obtain microbial interference specimens that SARS-CoV-2 is present in a specimen with one microorganism.
Each microbial interference specimen was tested individually. At each test, 50 µL samples were added to swab. The results shows that the specimen was confirmed positive for SARS-CoV-2 with faintly line on Line T. Based on the study, no appreciable interference was observed for the following substances at the spiked levels indicated below in sputum matrix.

S.N.

|

Potential Cross-Reactant

|

Concentration Tested

| Cross- Reactivity (Yes/No)
---|---|---|---
1| Human coronavirus 229E| 2.0 x 105 TCID50/mL| NO
2| Human coronavirus OC43| 2.0 x 105 TCID50/mL| NO
3| Human coronavirus NL63| 2.0 x 105 TCID50/mL| NO
4| SARS-coronavirus| 2.0 x 105 TCID50/mL| NO
5| MERS-coronavirus| 2.0 x 105 TCID50/mL| NO
6| Human coronavirus HKU1| 2.0 x 105 TCID50/mL| NO
7| Adenovirus C1| 2.0 x 105 TCID50/mL| NO
8| Adenovirus 71| 2.0 x 105 TCID50/mL| NO

9

| Human Metapneumovirus (hMPV)|

2.0 x 105 TCID50/mL

|

NO

10| Parainfluenza virus 1-4| 2.0 x 105 TCID50/mL| NO
11| Influenza A| 2.0 x 105 TCID50/mL| NO
12| Influenza B| 2.0 x 105 TCID50/mL| NO
13| Enterovirus| 2.0 x 105 TCID50/mL| NO
14| Respiratory syncytial virus| 2.0 x 105 TCID50/mL| NO
15| Rhinovirus| 2.0 x 105 TCID50/mL| NO
16| Haemophilus influenzae| 2.0 x 106 TCID50/mL| NO
17| Streptococcus pneumoniae| 2.0 x 106 TCID50/mL| NO
18| Streptococcus pyogenes| 2.0 x 106 TCID50/mL| NO
19| Candida albicans| 2.0 x 106 TCID50/mL| NO

20

| Pooled human nasal wash – representative of normal
respiratory microbial flora| 2.0 x 106 TCID50/mL| NO
21| Bordetella pertussis| 2.0 x 106 TCID50/mL| NO
22| Mycoplasma pneumoniae| 2.0 x 106 TCID50/mL| NO
23| Chlamydia pneumoniae| 2.0 x 106 TCID50/mL| NO
24| Legionella pneumophila| 2.0 x 106 TCID50/mL| NO
25| Mycobacterium tuberculosis| 2.0 x 106 TCID50/mL| NO
26| Pneumocystis jirovecii (PJP)| 2.0 x 106 TCID50/mL| NO

Human nasal swab specimen matrix

The microbial interference studies for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 (bei Resources NR-52286).
The material was supplied frozen at a concentration of TCID50 of 3.40 x105 per mL. the starting material was spiked into a volume of pooled nasal swab specimen (the most challenging respiratory matrix) obtained from healthy donors and confirmed negative for SARS-CoV-2. Based on the LOD studies, a low (3x LoD) SARS-CoV-2 concentration of 1.02x 103 TCID50/mL was chosen. The specimen was confirmed positive for SARS-CoV-2 with faintly line on Line T. Furthermore, the above-mentioned specimen was divided into 30.Finally, the microorganism indicated below was respectively spiked into the divided specimen to obtain microbial interference specimens that SARS-CoV-2 is present in a specimen with one microorganism.
Each microbial interference specimen was tested individually. At each test, 50 µL samples were added to swab. The results shows that the specimen was confirmed positive for SARS-CoV-2 with faintly line on Line T. Based on the study, no appreciable interference was observed for the following substances at the spiked levels indicated below in nasal swab specimen matrix.

S.N.

|

Potential Cross-Reactant

|

Concentration Tested

|

Cross- Reactivity (Yes/No)

---|---|---|---

1

|

Human coronavirus 229E

| 2.0 x 105 TCID50/mL|

NO

2

|

Human coronavirus OC43

| 2.0 x 105 TCID50/mL|

NO

3

|

Human coronavirus NL63

| 2.0 x 105 TCID50/mL|

NO

4

|

SARS-coronavirus

| 2.0 x 105 TCID50/mL|

NO

5

|

MERS-coronavirus

| 2.0 x 105 TCID50/mL|

NO

6

|

Human coronavirus HKU1

| 2.0 x 105 TCID50/mL|

NO

7

|

Adenovirus C1

| 2.0 x 105 TCID50/mL|

NO

8

|

Adenovirus 71

| 2.0 x 105 TCID50/mL|

NO

9

|

Human Metapneumovirus (hMPV)

|

2.0 x 105 TCID50/mL

|

NO

10

|

Parainfluenza virus 1-4

| 2.0 x 105 TCID50/mL|

NO

11

|

Influenza A

| 2.0 x 105 TCID50/mL|

NO

12

| Influenza B| 2.0 x 105 TCID50/mL|

NO

13

| Enterovirus| 2.0 x 105 TCID50/mL|

NO

14

| Respiratory syncytial virus| 2.0 x 105 TCID50/mL|

NO

15

| Rhinovirus| 2.0 x 105 TCID50/mL|

NO

16

| Haemophilus influenzae| 2.0 x 106 TCID50/mL|

NO

17

| Streptococcus pneumoniae| 2.0 x 106 TCID50/mL|

NO

18

| Streptococcus pyogenes| 2.0 x 106 TCID50/mL|

NO

19

| Candida albicans| 2.0 x 106 TCID50/mL|

NO

20

|

Pooled human nasal wash – representative of normal
respiratory microbial flora

|

2.0 x 106 TCID50/mL

|

NO

21

| Bordetella pertussis| 2.0 x 106 TCID50/mL|

NO

22

| Mycoplasma pneumoniae| 2.0 x 106 TCID50/mL|

NO

23

| Chlamydia pneumoniae| 2.0 x 106 TCID50/mL|

NO

24

| Legionella pneumophila| 2.0 x 106 TCID50/mL|

NO

Endogenous Interference Substances Studies:

Human sputum matrix

A study was performed demonstrate that eighteen (18) potentially interfering substances that may be found in the lower respiratory tract do not cross-react or interfere with the detection of SARS-CoV-2 in the SARS-CoV-2 Antigen Rapid Qualitative Test.

S.N

|

Interfering Substance

|

Concentration

| Cross- Reactive Results| Interference Results**
---|---|---|---|---
1| Whole Blood| 4%| Negative| Positive
2| Mucin| 0.50%| Negative| Positive
3| Ricola (Menthol)| 1.5 mg/mL| Negative| Positive
4| Sucrets
(Dyclonin/Menthol)| 1.5 mg/mL| Negative| Positive
5| Chloraseptic
(Menthol/Benzocaine| 1.5 mg/mL| Negative| Positive
6| Naso GEL (NeilMed)| 5% v/v| Negative| Positive
7| CVS Nasal Drops (Phenylephrine)| 15% v/v| Negative| Positive
8| Afrin (Oxymetazoline)| 15% v/v| Negative| Positive
9| CVS Nasal Spray (Cromolyn)| 15% v/v| Negative| Positive
10| Nasal Gel
(Oxymetazoline)| 10% v/v| Negative| Positive
11| Zicam| 5% v/v| Negative| Positive
12| Homeopathic (Alkalol)| 1:10 dilution| Negative| Positive
13| Fisherman’s Friend| 1.5 mg/mL| Negative| Positive
14| ore Throat Phenol Spray| 15% v/v| Negative| Positive
15| Tobramycin| 4μg/mL| Negative| Positive
16| Mupirocin| 10 mg/mL| Negative| Positive
17| Fluticasone Propionate| 5% v/v| Negative| Positive
18| Tamiflu (Oseltamivir Phosphate)| 5mg/mL| Negative| Positive

Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen Rapid Qualitative Test do not cross-react or interfere.

Human nasal swab specimen matrix

A study was performed demonstrate that eighteen (18) potentially interfering substances that may be found in the upper respiratory tract do not cross-react or interfere with the detection of SARS-CoV-2 in the SARS-CoV-2 Antigen Rapid Qualitative Test.

S.N

|

Interfering Substance

|

Concentration

| Cross- Reactive Results| Interference Results**
---|---|---|---|---
1| Whole Blood| 4%| Negative| Positive
2| Mucin| 0.50%| Negative| Positive
3| Ricola (Menthol)| 1.5 mg/mL| Negative| Positive

4

| Sucrets
(Dyclonin/Menthol)| 1.5 mg/mL| Negative| Positive

5

| Chloraseptic
(Menthol/Benzocaine| 1.5 mg/mL| Negative| Positive
6| Naso GEL (NeilMed)| 5% v/v| Negative| Positive
7| CVS Nasal Drops (Phenylephrine)| 15% v/v| Negative| Positive
8| Afrin (Oxymetazoline)| 15% v/v| Negative| Positive
9| CVS Nasal Spray (Cromolyn)| 15% v/v| Negative| Positive
10| Nasal Gel
(Oxymetazoline)| 10% v/v| Negative| Positive
11| Zicam| 5% v/v| Negative| Positive
12| Homeopathic (Alkalol)| 1:10 dilution| Negative| Positive
13| Fisherman’s Friend| 1.5 mg/mL| Negative| Positive
14| ore Throat Phenol Spray| 15% v/v| Negative| Positive
15| Tobramycin| 4μg/mL| Negative| Positive
16| Mupirocin| 10 mg/mL| Negative| Positive
17| Fluticasone Propionate| 5% v/v| Negative| Positive
18| Tamiflu (Oseltamivir Phosphate)| 5mg/mL| Negative| Positive

HIGH DOSE HOOK EFFECT

As part of the LoD study the highest concentration of heat-inactivated SARS- CoV-2 stock available (TCID50 of 3.40 x105 per mL) was tested. There was no Hook effect detected.

INDEX OF SYMBOLS

Do not re-use

| Expiry date| | Consult instructions for use
| Warning, please refer to the instruction| |

Manufacturer

| Store at 2-30℃| | Lot number
| Keep away from sunlight| |

Keep dry

| European authorized representative| | Don’t use the product
when the package is damaged
| Date of manufacture| | Biological risks
| For Prescription Only| | CE mark
| Sterilized using ethylene oxide| |

IN VITRO DIAGNOSTIC MEDICAL DEVICE TECHNICAL ASSISTANCE

For technical assistance, call Biotime Technical Services at +86-592-688-3577, email baotai@biotime.cn, or visit Biotime website at http://www.biotime.cn.

GENERAL INFORMATION

Manufactured by:
Xiamen Biotime Biotechnology Co., Ltd
Address: 3F/4F, No. 188, Pingcheng South Road, Haicang District, Xiamen, Fujian, 361026, P.R.China
Tel: +86-592-6883577
Fax: +86-592-6882362
www.biotime.cn
Manufactured for: Innova Medical Group Inc.

Innova Medical Group Inc.
Address: 718 S. Primrose Ave, Monrovia, CA 91016, USA
Tel: 626-239 0025
Fax: 626-239 0038
www.innovamedgroup.com

References

• Advancing the World of Health | BD
• 新型冠状病毒检测试剂供应商|POCT|厦门宝太生物科技股份有限公司
• 新型冠状病毒检测试剂供应商|POCT|厦门宝太生物科技股份有限公司
• Innova Medical Group | Global Leader In Antigen Testing
• innovamedgroup.com/

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