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GENESIS Group

EZER™ Flu & COVID-19 Antigen Duo Rapid Test Device

POCT

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    <p class="MsoNormal">The EZER&trade; Flu &amp; COVID-19 Antigen Duo Rapid Test Device is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from <strong>SARS-CoV-2</strong>, <strong>influenza A </strong>and <strong>influenza B</strong> from nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection, within the first three days of onset of symptoms.&nbsp;Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.</p>
<p class="MsoNormal">This test is for laymen with self-collected nasal (nares) swab samples from individuals aged 14 years or older, or adult collected nasal swab samples from individuals aged 2 years or older. Results are for the simultaneous identification of nucleocapsid antigens of SARS-CoV-2, influenza A and influenza B, but does not differentiate between SARS-CoV and SARS-CoV-2 viruses. These viral antigens are generally detectable in nasal swab samples during the acute phase of infection.</p>
<p class="MsoNormal">Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of the disease. Positive result is advised to consult with a medical practitioner, and follow local authorities' recommendations, and not take any decision of medical relevance without first consulting their medical practitioner.</p>
<p class="MsoNormal">Negative results should be considered in the context of an individual&rsquo;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. Negative influenza A and B test results should be treated as presumptive. It is recommended these results be confirmed an influenza A and B molecular assay. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. User should contact medical practitioner if symptoms or other infection suspicion persist.</p>
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    <p class="MsoNormal">Nasal Swabbing</p>
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    <p class="MsoNormal">Read results at 15 minutes and no more than 30 minutes.</p>
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    <p class="MsoNormal">Test devices must be stored at 2~30&deg;C. DO NOT FREEZE. After storage in&nbsp;refrigerator, devices must be brought back to room temperature for at least 30&nbsp;minutes before testing.</p>
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<p class="MsoNormal" style="text-align: left;" align="right"><strong><span style="font-family: Arial;">C</span></strong><strong>at. No.</strong></p>
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<p class="MsoNormal" align="center"><strong><span style="font-family: Arial;">P2</span></strong><strong>13106</strong></p>
</td>
<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><strong><span style="font-family: Arial;">P2</span></strong><strong>13107</strong></p>
</td>
<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><strong><span style="font-family: Arial;">P2</span></strong><strong>13109</strong></p>
</td>
</tr>
<tr>
<td style="width: 45.0479%;" valign="center" width="120">
<p class="15">Test device</p>
</td>
<td style="width: 18.2109%;" valign="top" width="63">
<p class="MsoNormal" align="center">1</p>
</td>
<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">5</span></p>
</td>
<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">2</span>0</p>
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<p class="15">Sterilized swab</p>
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<td style="width: 18.2109%;" valign="top" width="63">
<p class="MsoNormal" align="center">1</p>
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<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">5</span></p>
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<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">2</span>0</p>
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<p class="15">Extraction tube<span style="font-family: 等线;">（</span><span style="font-family: 等线;">with</span>&nbsp;<span style="font-family: 等线;">Extraction</span>&nbsp;<span style="font-family: 等线;">buffe</span>r<span style="font-family: 等线;">）&nbsp;</span></p>
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<td style="width: 18.2109%;" valign="top" width="63">
<p class="MsoNormal" align="center">1</p>
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<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">5</span></p>
</td>
<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">2</span>0</p>
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<p class="15">Tube Stand</p>
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<td style="width: 18.2109%;" valign="center" width="63">
<p class="MsoNormal" align="center">&nbsp;</p>
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<p class="MsoNormal" align="center">&nbsp;</p>
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<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">1</span></p>
</td>
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<p class="15">Package Insert</p>
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<td style="width: 18.2109%;" valign="center" width="63">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">1</span></p>
</td>
<td style="width: 18.4239%;" valign="center" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">1</span></p>
</td>
<td style="width: 18.4239%;" valign="top" width="64">
<p class="MsoNormal" align="center"><span style="font-family: Arial;">1</span></p>
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<td style="width: 46.1129%; height: 20.6667px;" valign="center" width="191">
<p class="MsoNormal" align="center"><strong>Product</strong></p>
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<td style="width: 18.4239%; height: 20.6667px;" valign="center" width="49">
<p class="MsoNormal" align="center"><strong>Cat. No.</strong></p>
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<p class="MsoNormal" align="center"><strong>Contents</strong></p>
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<p class="MsoNormal">EZER&trade; Flu &amp; COVID-19 Antigen Duo Rapid Test Device&nbsp;</p>
</td>
<td style="width: 18.4239%; height: 20.6667px;" valign="center" width="49">
<p class="MsoNormal" align="center">P213106</p>
</td>
<td style="width: 35.4633%; height: 20.6667px;" valign="center" width="141">
<p class="MsoNormal" align="center">1 Test</p>
</td>
</tr>
<tr style="height: 21.6667px;">
<td style="width: 18.4239%; height: 21.6667px;" valign="center" width="49">
<p class="MsoNormal" align="center">P213107</p>
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<td style="width: 35.4633%; height: 21.6667px;" valign="center" width="141">
<p class="MsoNormal" align="center">5 Tests</p>
</td>
</tr>
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<td style="width: 18.4239%; height: 20.6667px;" valign="center" width="49">
<p class="MsoNormal" align="center">P213109</p>
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<td style="width: 35.4633%; height: 20.6667px;" valign="center" width="141">
<p class="MsoNormal" align="center">20 Tests</p>
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A rapid test for the detection of influenza, influenza B and SARS-CoV-2 antigens in nasal specimens. For self-test only.