Description
A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For in Vitro Diagnostics use only. For self-testing. Three kit types are available: 1. L031-118M5 (Single pack)2. L031-118P5 (5T/pack)3. L031-118R5 (25T/pack) The Flowflex SARS-CoV-2 Antigen Rapid Test is registered in the following countries: Thailand, Indonesia, Myanmar, Hong Kong, Bosnia & Herzegovina, Peru, Saudi Arabia, Nepal, Vietnam and Malaysia.
Description:
<p><p>A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For in Vitro Diagnostics use only. For self-testing.&nbsp;</p> <p>&nbsp;</p> <p>Three kit types are available:</p> <p>1. L031-118M5 (Single pack)<br /> 2.&nbsp;L031-118P5 (5T/pack)<br /> 3.&nbsp;L031-118R5 (25T/pack)</p> <p>&nbsp;</p> <p>The Flowflex&nbsp;SARS-CoV-2 Antigen Rapid Test is registered in the following countries: Thailand, Indonesia, Myanmar, Hong Kong, Bosnia &amp; Herzegovina, Peru, Saudi Arabia, Nepal, Vietnam&nbsp;and Malaysia.&nbsp;</p></p>
Product Bundled:
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Intended use:
The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. The test can also test specimens from individuals without symptoms.
Intended user:
A nasal swab sample can be self-collected by an individual aged 18+ years. Children under 18 years of age should be performed with adult supervision. Please follow your local guidelines for specimen collection by children.
Technology principle:
Immunoassay
Antigen target:
Nucleocapsid antigen
Test format:
Cassette
Sample type:
Anterior nasal swab
Sensitivity:
97.1%
Specificity :
99.5%
Number of tests per unit:
3 kit types (1, 5 & 25 tests per kit)
Shelf life :
24 months
Storage conditions:
Store at 2 - 30°C. Do not freeze.
Operating conditions:
Allow the test device to reach room temperature before testing if stored in a refrigerator. Ideally, should be operated at room temperature, between 15-30°C.
HS code:
3822190020
Transportation :
By International transportation mode such as air or sea
Cold chain requirements:
No
Contents of kit:
Test Cassette, Extraction Buffer Tube, Disposable Swab, Waste Bag, Tube Holder (For 25T only), Package Insert
Equipment required but not provided:
Timer
Instrument requirements:
None
Language options:
English
Name of manufacturer :
ACON Biotech (Hangzhou) Co., Ltd
Country of manufacture:
China
Ordering and Incoterms:
<p> </p>
<ul>
<li>Prices are indicative and reflect the ex-works price available.</li>
<li>Flowflex SARS-CoV-2 Antigen Rapid Tests are available in packs containing 1 test, 5 tests and 25 tests per pack.</li>
<li>Incoterms are negotiated between the supplier (or its local distributor) and the buyer.</li>
<li>The final price is dependent on: Incoterms, order volume, freight, taxes, customs duties, handling fees and other applicable fees. </li>
<li>Upon Request for Quotation, the buyer will receive a quotation with the applicable final price. Learn more about pricing on the DxConnect Marketplace in our helpdesk <u><a href="https://diagnostics.zendesk.com/hc/en-us/articles/4429547242521-Pricing-on-DxConnect-Marketplace" target="_blank">here</a></u>.</li>
</ul>
Volume pricing:
<table border="1" cellpadding="1" cellspacing="1" style="width:500px">
<tbody>
<tr>
<td> </td>
<td colspan="3" rowspan="1">Number of tests per pack</td>
</tr>
<tr>
<td> </td>
<td>L031-118M5 (1T/pack)</td>
<td>L031-118P5 (5T/pack)</td>
<td>L031-118R5 (25T/pack)</td>
</tr>
<tr>
<td>Indicative price per test (USD)</td>
<td>1</td>
<td>0.9</td>
<td>0.8</td>
</tr>
</tbody>
</table>
<p> </p>
Pricing Description:
Ex-Works Price for a pack of 25 tests
Reporting units :
IFCC (mmol/mol) / NGSP/DCCT (%)
