DESCRIPTION

The Diaghome COVID-19 / RSV / Flu A&B Antigen Test Kit is a rapid, easy-to-use diagnostic tool designed to detect multiple respiratory infections in one test. It provides accurate results for COVID-19, RSV, and Flu A&B antigens, helping users quickly identify the cause of their symptoms. Ideal for home use, it offers fast results in minutes, aiding in early diagnosis and treatment decisions.

INTENDED USE

The COVID-19/RSV/Influenza A&B Antigen Test Kit is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial, influenza A and influenza B viral nucleoprotein antigens in nasal swabs from subjects. The symptoms of respiratory viral infection due to SARS-CoV-2, respiratory syncytial, influenza can be similar. The test is intended as an aid in diagnosis of symptomatic individual meeting respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms). This kit is intended for layperson's home use in a non-laboratory environment. Test results of this kit are for clinical reference only. It is recommended that a comprehensive analysis of the disease be conducted based on clinical manifestations of patients and other laboratory tests.

PRECAUTIONS

1. For in vitro diagnostic use only.
2. Do not use after the expiration date.
3. Perform the test at room temperature 15 to 30°C.
4. The test cassette should remain in the sealed pouch until use.
5. Please read all information in this leaflet before performing the test.
6. Components from difference lots must not be mixed or used together.
7. Positive result cannot necessarily determine whether a person is infectious

STORAGE AND STABILITY

• Store the test kit in the original packaging at 2°C - 30°C. Do not freeze. Test kit contents remain stable until theexpiration date printed on the outer packaging.
• After opening the pouch, the test should be used within one hour. Prolonged contact with hot and humid environment will cause the product to deteriorate.

LIMITATION

A negative result does not rule out infection with another type of respiratory virus. And a positive result cannot necessarily determine whether a person is infectious.

• The test can only be used once.
• Test can only be performed by person over 15 years age. Any persons or children under 15 years will require adult supervision or assistance. Not to be performed on children under 2 years of age.
• The performance of COVID-19/RSV/Influenza A&B Antigen Test Kit was established based on the evaluationof a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS CoV-2 and their prevalence, which change over time.
• In particular, false negative results may occur if the testing is not performed within the first 7 days of the onset of COVID-19 or within the first 4 days of influenza A&B/RSV symptoms or if the antigen level in the sample is below the detection limit.
• The tests are less reliable in the later phase of infection and in asymptomatic individuals.
• Recommend repeat testing within 1-3 days if there is an ongoing suspicion of infection, being in a high risk setting or where there is an occupational risk or other requirement.
• Negative results may not mean that a person is not infectious and if symptoms persist, please seek medical advice.

SAFETY INFORMATION

• Wearing a mask can help protect you and those around you if you are in an area with community transmission and physical distancing is not possible.
• Follow the directions of your local state or territory government health department to protect yourself.
• Test kit solutions should only be used as directed; do not ingest; do not dip the swab into provided solution or other liquid before inserting the swab into the nose; avoid contact with skin and eyes; keep out of the reach of children and pets before and after use.
• If the extraction buffer comes in contact with the skin or eyes, flush with plenty of water. If irritation persists, seek medical advice from a doctor or your local medical center.

PERFORMANCE CHARACTERISTICS

For COVID-19

Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A sensitivity of 95.45% (210/220 known confirmed Positives) and a specificity of 99.03% (307/310 knownconfirmed Negatives) were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For influenza A test

UsingCOVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A sensitivity of 93.48%(86/92 known confirmed Positives)and a Specificity of 98.29% (288/293 known confirmed Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For influenza B test

Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A sensitivity of 91.11% (82/90 known confirmed Positives) and a Specificity of 97.89% (278/284 known confirmed Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For RSV test

Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A sensitivity of 94.81% (201/212 known confirmed Positives) and a Specificity of 98.87% (175/177 known confirmed Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

Usability Study

Lay users in different age distribution, different education level and different gender participated in usability study conducted in the self-testing environment. Compared to RT-PCR, the clinical performance of COVID19/RSV/Influenza A&B Antigen Test Kit in hands of lay persons showed a sensitivity of 94.87% (N=39) and a specificity of 98.57% (N=70) for COVID-19 antigen, a sensitivity of 94.29% (N=35) and a specificity of 98.57% (N=70) for RSV antigen, a sensitivity of 90.00% (N=30) and a specificity of 98.57% (N=70) for influenza A antigen and a sensitivity of 93.33% (N=30) and a specificity of 98.57% (N=70) for influenza B antigen.

FREQUENTLY ASKED QUESTIONS

1. Will other diseases affect the result?

The potential cross-reactivity of the following pathogens was evaluated with SARS-CoV-2, Influenza A and B negative and positive samples using the COVID 19/RSV/Influenza A&B Antigen Test Kit. No cross-reactivity results was observed.

2. Do these substances interfere with the test?

The following substances were spiked into samples and tested with the COVID-19/RSV/Influenza A&B Antigen Test Kit. No interference results was observed.

3. Will this test hurt?

No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider.

4. I have a nosebleed after swabbing my nose. What should I do? 

In the unlikely event your nose starts bleeding, apply pressure to your nose until the bleeding stops and consult a healthcare professional. Do not insert the Swab again.

5. Can the test detect various variants of COVID-19?

Yes, the following SARS-CoV-2 variants can be detected with the COVID-19 (SARS-CoV-2) Antigen Test Kit: Alpha, Beta, Gamma, Delta and Omicron

8. What to do if you test positive?

Anyone diagnosed with COVID-19 can pass the virus onto others. While isolation is no longer a legal requirement, if you test positive for COVID-19, staying at home protects the people in your community.

If you test positive, you should not visit high-risk settings like hospitals and aged and disability care settings:

for at least 7 days or until symptoms have gone unless seeking immediate medical care.

• To help protect those around you, we recommend:  avoiding contact with people who are at higher risk of severe disease  wearing a mask outside the home  working from home where possible avoiding going to school, public areas, or travel on public transport, in taxis or ride-share services practicing good hygiene following your local health department’s advice when leaving home.
• If you have any appointments you cannot miss (visit to a doctor, family violence service or police), let them know in advance that you have COVID-19.
• If you feel unwell or need COVID-19 advice for someone in your care, talk with your health provider, or speak to a nurse by calling the healthdirect helpline on 1800 022 222.
• If you develop symptoms such as severe shortness of breath or chest pain, call triple zero (000) immediately. Tell the call handler and the paramedics on arrival if you have COVID-19.

Item Dimensions LxWxH : 0.00 x 0.00 x 0.00 Centimeters