Instructions TestsiDuo Express test for the detection of antigens of influenza A/B viruses and COVID-19 coronavirus No. 1
Reservation
- For in vitro diagnostic use only. Read the instructions for use carefully before testing. Follow storage conditions.
- To obtain accurate results, diagnostics should be performed in accordance with the recommendations of this instruction.
- During the diagnosis, persons under the age of 18 and persons with any disabilities must be under the supervision of adults or require their assistance. This test is not recommended for children under 2 years of age.
- Wash your hands thoroughly before and after performing the diagnosis.
- If a third party collects the sample and performs the diagnosis, they should read the instructions for use and use personal protective equipment (disposable gloves, disposable mask) before starting the diagnostic procedure.
- All specimens should be handled as if they contain infectious agents. Dispose of them in accordance with local regulations for the disposal of biohazardous waste.
- Do not use this kit after the expiration date stated on the package.
- Use only undamaged rapid test. All components of this rapid test must remain sealed until used.
- Only the extraction buffer tube provided with this rapid test should be used. Do not substitute the extraction buffer solution for this rapid test with buffer solution from other lots or any components of other rapid tests.
- Please note that excessive humidity and ambient temperature may negatively affect the analysis results.
- All components of the rapid test are disposable. Do not reuse them.
- The diagnostic procedure should occur immediately after opening and removing the rapid test from the individual packaging.
- Make sure that a sufficient amount of sample is used for diagnosis. Too much or too little sample may lead to incorrect results.
- Visually bloody or excessively viscous samples may lead to incorrect results.
- Never drink the buffer solution. If the buffer solution gets into your eyes and/or on your skin, rinse them thoroughly with water. If you feel unwell, seek medical attention immediately.
- The result should be read after 15 minutes (min). A result read after 20 minutes (min) is considered invalid.
- Do not disassemble the plastic case of the rapid test and do not touch the test strip.
Storage conditions
- The rapid test should be stored in its original packaging at a temperature of +2 °C to +30 °C.
- Do not freeze any components of the rapid test.
- Do not use the rapid test after the expiration date.
- The rapid test pen should remain in its sealed packaging until used.
- During diagnosis, the rapid test pen should be used within 1 hour (h) after opening the sealed pouch at an ambient temperature of +15 °C to +30 °C and a relative humidity of no more than 60%. If the relative humidity is higher, the rapid test pen should be used immediately.
- Store in original packaging, in a dry place, protected from direct sunlight.
Recommendations for use
The rapid test is used to analyze a nasal swab and is intended for self-monitoring.
Diagnostics should be performed after the rapid test pen and the extraction tube with buffer solution have reached room temperature (+15 °C to +30 °C).
Before starting sample collection:
- Please read the instructions for use carefully.
- Prepare a clean work area for diagnostics.
- Make sure that all components of the rapid test kit are present and undamaged.
Sequence of material collection, sample preparation and diagnostics:
- Unpack the sealed bag containing the test pen.
- Carefully, without touching the swab, remove the protective cap from the test pen and sample collection pad.
- The tip of the test pen swab should be inserted 2-4 centimeters (cm) into the nasal cavity (nostril) until resistance is felt. Do not insert the swab any further if you feel strong resistance or pain.
- Slowly rotate the swab 5 times inside the nasal cavity. Repeat this process with the same swab for the other nasal cavity to ensure sufficient sample is collected.
- Slowly rotate the test pen to remove the swab from the nasal cavity. Do not touch the soft tip to avoid contamination. The sample is now ready for preparation using the extraction buffer provided in the test kit.
- Place the tube with the buffer solution on a clean, flat surface and remove the protective foil.
- After 15 minutes (min), but no later than 20 minutes (min), check the result. If the result is not read within the specified time, the diagnostic result is considered invalid and it is recommended to perform the diagnosis again.
Samples should be tested as soon as possible after collection for best diagnostic efficiency. If immediate testing is not possible, to ensure best results, avoid possible environmental contamination and sample deterioration, the test pen should be closed with the protective cap and stored at room temperature (+15 °C to +30 °C) for no more than 1 hour (h) for subsequent testing. Ensure that the protective cap is tightly closed. If the delay in testing exceeds 1 hour (h), discard the test pen with the sample; a new rapid test and sample should be used for testing.
INTERPRETATION OF RESULTS
Negative
Influenza A and B and COVID-19 negative
In the control zone for influenza A and B and coronavirus, a red band appears only opposite the control "C", other colored lines are absent. This means that no antigen of influenza A virus or influenza B virus or coronavirus (COVID-19) is detected in the sample.
The sample is likely not infected with influenza A/B and coronavirus (COVID-19) at the time of diagnosis. This does not guarantee complete absence of infection with influenza A/B or coronavirus (COVID-19). Individuals with a negative test result are recommended to undergo laboratory PCR testing if they have symptoms. Please pay attention to the symptoms and seek medical attention if symptoms persist.
Positive
- Influenza A: A red line opposite the control “C” and in the test region “A” indicates a positive result for influenza A virus antigen.
- Influenza B: A red line opposite the control “C” and in the test region “B” indicates a positive result for influenza B virus antigen.
- Influenza A+B: A red band opposite the control “C” and in the test region “A” and “B” indicates a positive result for influenza A and influenza B virus antigen.
- COVID-19: a red band opposite the control “C” and in the test zone “S” indicates a positive result for the SARS-CoV-2 virus antigen.
- COVID-19 + Influenza A: A red band opposite the control “C”, in the test zone “A” and “S” indicates a positive result for influenza A virus antigen and SARS-CoV-2 virus antigen.
- COVID-19 + Influenza B: A red band opposite the control “C”, in the test zone “B” and “S” indicates a positive result for influenza B virus antigen and SARS-CoV-2 virus antigen.
- COVID-19 + Influenza A+B: A red band opposite the control “C”, in the test zone “A”, “B” and “S” indicates a positive result for influenza A virus antigen, influenza B virus antigen and SARS-CoV-2 virus antigen.
One or more positive results indicate a high probability of infection with one or more viral agents and the possibility of infecting others. Please follow the instructions of the Ministry of Health, consult a doctor to determine the need for a confirmatory laboratory PCR test; seek medical attention if you feel unwell.
The intensity of the color in the test line region may vary depending on the concentration of viral antigens present in the specimen. Accordingly, any shade of color in the test line region should be considered positive.
Invalid
If the control line “C” does not appear in the result window after performing the test, the result is considered invalid.
It is recommended to re-read the instructions for use and repeat the diagnosis using a new rapid test. Do not use components from a previous rapid test. If the problem persists, immediately stop using the rapid test and contact an authorized representative (details are listed at the end of the instructions).
DO NOT MAKE ANY MEDICAL DECISIONS BASED ON THE DIAGNOSTIC RESULTS WITHOUT CONSULTING A DOCTOR!
WASTE DISPOSAL
After diagnosis, used rapid test components and personal protective equipment should be disposed of in accordance with local regulations for the disposal of biohazardous waste. Wash hands after completing all procedures.
QUALITY CONTROL
The rapid test includes an internal procedure control. The red line that appears in the control zone "C" during the test is the internal procedure control. It indicates the sufficiency of the sample volume and the correctness of the applied procedure technique.
PERFORMANCE CHARACTERISTICS
Detection limit (analytical sensitivity)
The detection limit of SARS-CoV-2 virus (wild type) is 1.15×102 TCID50/ml.
The detection limit for influenza A (H1N1) virus is 3×105 TCID50/ml.
The detection limit for influenza B (Yamagata) virus is 3×106 TCID50/ml.
Note: TCID50 – cytopathic dose, 50% tissue culture infectious dose.
Hook effect
Note: Hook effect is an immunological phenomenon in which the effectiveness of antibodies in forming immune complexes is impaired due to too high a concentration of antibodies or antigens. The formation of immune complexes ceases to increase at higher concentrations and then decreases at extremely high concentrations. The important practical significance of this phenomenon is that it is a type of interference that interferes with certain immunological and nephelometric assays, leading to false negative results or inaccurately low results. Other common forms of interference include antibody interference, cross-reaction, and signal interference. This phenomenon is caused by very high concentrations of a particular analyte or antibody.
Diagnostic sensitivity and specificity
The rapid test was compared with a commercial PCR test. The results of clinical studies are:
| SARS-CoV-2 virus antigen detection | PCR | In general | |
| positive | negative | | |
| Positive | 58 | 0 | 58 |
| Negative | 0 | 152 | 152 |
| In general | 58 | 152 | 210 |
The overall sensitivity, according to the table above, is 100% (95% CI: 93.84-100%).
The overall specificity, according to the table above, is 100% (95% CI: 97.6-100%).
The overall agreement, according to the table above, is 100% (95% CI: 98.26-100%).
| Determination of influenza A virus antigen | PCR | In general | |
| positive | negative | | |
| Positive | 70 | 0 | 70 |
| Negative | 1 | 152 | 153 |
| In general | 71 | 152 | 223 |
The overall sensitivity, according to the table above, is 98.59% (95% CI: 92.4-99.96%).
The overall specificity, according to the table above, is 100% (95% CI: 97.6-100%).
The overall agreement, according to the table above, is 99.55% (95% CI: 97.53-99.99%).
| Influenza B virus antigen detection | PCR | In general | |
| positive | negative | | |
| Positive | 70 | 0 | 70 |
| Negative | 1 | 152 | 153 |
| In general | 71 | 152 | 223 |
The overall sensitivity, according to the table above, is 98.59% (95% CI: 92.4-99.96%).
The overall specificity, according to the table above, is 100% (95% CI: 97.6-100%).
The overall agreement, according to the table above, is 99.55% (95% CI: 97.53-99.99%).
Cross-reactivity
The cross-reactivity of the rapid test was evaluated by testing pathogens that could potentially cross-react with the analyte detection reagents in this rapid test.
| Possible cross-contamination | Concentration | Express test | | |
|---|
| SARS-CoV-2 | Influenza A | Influenza B | | |
|---|
| Adenovirus 1 | 3.09×105 TCID50/ml (TCID50/ml) | – | – | – |
| Adenovirus 2 | 2.8×105 TCID50/ml (TCID50/ml) | – | – | – |
| Adenovirus 3 | 5×105.5 TCID50/ml (TCID50/ml) | – | – | – |
| Adenovirus 4 | 1×105 PFU/ml (PFU/ml) | – | – | – |
| Adenovirus 5 | 1×105 PFU/ml (PFU/ml) | – | – | – |
| Adenovirus 7 | 2.8×105 TCID50/ml (TCID50/ml) | – | – | – |
| Adenovirus 55 | 1×105 PFU/ml (PFU/ml) | – | – | – |
| Enterovirus A71 | 3.55×105 TCID50/ml (TCID50/ml) | – | – | – |
| Enterovirus B69 | 1×105 PFU/ml (PFU/ml) | – | – | – |
| Enterovirus C95 | 1×105 PFU/ml (PFU/ml) | – | – | – |
| Enterovirus D70 | 1×105 PFU/ml (PFU/ml) | – | – | – |
| Parotitis | 1×105 PFU/ml (PFU/ml) | – | – | – |
| Human metapneumovirus (hMPV) | 3.55×105 TCID50/ml (TCID50/ml) | – | – | – |
| Respiratory syncytial virus type A | 5.5×105 PFU/ml (PFU/ml) | – | – | – |
| Respiratory syncytial virus type B | 2.8×105 TCID50/ml (TCID50/ml) | – | – | – |
| Rhinovirus | 1.41×105 TCID50/ml (TCID50/ml) | – | – | – |
| Chickenpox virus | 1×106 PFU/ml (PFU/ml) | – | – | – |
| Influenza A virus H1N1, novel (2009) | 1×106 PFU/ml (PFU/ml) | – | N/A | – |
| Influenza A virus H1N1, seasonal | 1×105 PFU/ml (PFU/ml) | – | N/A | – |
| Influenza A H3N2 virus | 3.55×105 TCID50/ml (TCID50/ml) | – | N/A | – |
| Influenza A virus type H5N1 | 1×106 PFU/ml (PFU/ml) | – | N/A | – |
| Influenza B Yamagata virus | 1.8×105 CEID50/ml | – | – | N/A |
| Influenza B virus Victoria | 1.7×105 CEID50/ml | – | – | N/A |
| Parainfluenza virus type 1 | 1.6×105 TCID50/ml (TCID50/ml) | – | – | – |
| Parainfluenza virus type 2 | 1.6×105 TCID50/ml (TCID50/ml) | – | – | – |
| Parainfluenza virus type 3 | 1.6×105 TCID50/ml (TCID50/ml) | – | – | – |
| Parainfluenza virus type 4 | 1.15×105 TCID50/ml (TCID50/ml) | – | – | – |
| Human coronavirus 229E | 1.41×105 TCID50/ml (TCID50/ml) | – | – | – |
| 1.05×105 TCID50/ml (TCID50/ml) | – | – | – |
| Human coronavirus NL63 | 1.17×105 TCID50/ml (TCID50/ml) | – | – | – |
| Human coronavirus HKU1 | 1×106 PFU/ml (PFU/ml) | – | – | – |
| Bordetella pertussis | 7.5×106 CFU/ml (CFU/ml) | – | – | – |
| Candida albicans | 9.5×106 CFU/ml (CFU/ml) | – | – | – |
| Chlamydia pneumoniae | 7.5 x 106 IFU/ml (IFU/ml) | – | – | – |
| Haemophilus influenzae | 5.2×106 CFU/ml (CFU/ml) | – | – | – |
| Legionella pneumophila | 1.91×106 CFU/ml (CFU/ml) | – | – | – |
| Mycobacterium tuberculosis | 2.3×106 CFU/ml (CFU/ml) | – | – | – |
| Mycoplasma pneumoniae | 2.7×106 CCU/ml (ml) | – | – | – |
| Streptococcus pyogenes | 3.6×106 CFU/ml (CFU/ml) | – | – | – |
| Streptococcus pneumoniae | 4.2×106 CFU/ml (CFU/ml) | – | – | – |
| Staphylococcus aureus | 3.2×108 CFU/ml (CFU/ml) | – | – | – |
| Staphylococcus epidermidis | 2.1×108 CFU/ml (CFU/ml) | – | – | – |
| Pooled human nasal swab is a representative of normal respiratory microbial flora | N/A | – | – | – |
N/A – not applicable;
“–” – no cross-reactivity;
PFU – plaque-forming units;
CCU (color-changing unit) – color-changing unit;
CEID50 – 50% chicken embryo infectious dose;
IFU – infectious viral particles;
CFU – colony-forming units.
The results revealed no cross-reactivity.
Interfering substances
The sensitivity and specificity of the rapid test are not affected by the substances listed below:
| Analytes | Concentration |
|---|
| Whole blood (Trilon B as anticoagulant) | 20% v/v (v/v) |
| Mucin | 5 mg/ml (mg/ml) |
| Oseltamivir phosphate | 5 mg/ml (mg/ml) |
| Ribavirin | 5 mg/ml (mg/ml) |
| Levofloxacin | 5 mg/ml (mg/ml) |
| Azithromycin | 5 mg/ml (mg/ml) |
| Meropenem | 5 mg/ml (mg/ml) |
| Tobramycin | 2 mg/ml (mg/ml) |
| Paracetamol | 10 mg/ml (mg/ml) |
| Acetylsalicylic acid | 20 mg/ml (mg/ml) |
| Chlorpheniramine | 5 mg/ml (mg/ml) |
| Dextromethorphan | 10 mg/ml (mg/ml) |
| Diphenhydramine | 5 mg/ml (mg/ml) |
| Ephedrine | 20 mg/ml (mg/ml) |
| Guaifenesin | 20 mg/ml (mg/ml) |
| Phenylpropanolamine | 20 mg/ml (mg/ml) |
| Phenylephrine | 20% v/v (v/v) |
| Oxymetazoline | 20% v/v (v/v) |
| 0.9% sodium chloride solution | 20% v/v (v/v) |
| Alkalol (nasal rinse solution) | 20% v/v (v/v) |
| Beclomethasone | 20% v/v (v/v) |
| Hexadecadrol | 20% v/v (v/v) |
| Flunisolide | 20% v/v (v/v) |
| Triamcinolone | 20% v/v (v/v) |
| Budesonide | 20% v/v (v/v) |
| Mometasone | 20% v/v (v/v) |
| Fluticasone | 20% v/v (v/v) |
| Fluticasone propionate | 20% v/v (v/v) |
Producer
Zhejiang Orient Jen Biotech Co., Ltd.
3787, East Yangguan Avenue, Daipu Street Anji 313300 Hangzhou, Zhejiang, China.
Authorized representative: LLC "ATIS PHARMA", 03022, Ukraine, Kyiv, Kozatska St., 122.
