LEAD HORIZON COVID-19 Patented Test Kit Instructions

: June 4, 2024
: LEAD HORIZON

Table of Contents

GEBRAUCHSANWEISUNG
INSTRUCTIONS FOR USE
ACTIVATING THE TEST
TAKING THE SAMPLE
IMPORTANT INFORMATION:
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

COVID-19 Patented Test Kit
Instructions

GEBRAUCHSANWEISUNG

INSTRUCTIONS FOR USE

PROBENUMMER…………..
NAME………………………………..
DATE………………………
GUT AUFBEWAHREN
STORE SAFELY
STEP 1

OPEN YOUR TEST BOX AND CHECK THE CONTENTS. IT SHOULD CONTAIN THE FOLLOWING COMPONENTS. TAKE A LOOK AT EVERYTHING AT YOUR LEISURE.

| 1. Sample tube
---|---
| 2. Saline solution
| 3. Transfer tube
| 4. Instructions for use
| 5. Protective pouch
| 6. Absorbent paper

STEP 2

TAKE YOUR SMARTPHONE, TABLET, PC, OR LAPTOP.
OPEN THE lead-horizon.org/basic WEBSITE OR SCAN THE QR CODE WITH YOUR PHONE OR OTHER DEVICE.
SIMPLY FOLLOW THE INSTRUCTIONS IN THE WEBAPP. THANK YOU FOR GETTING TESTED!

LEAD HORIZON COVID-19 Patented Test Kit - qr code

https://[cw4.lead-horizon.org/basic](http://cw4.lead-horizon.org/basic)
lead-horizon.org/basic

INSTRUCTIONS FOR USE

Thank you for getting yourself tested! To perform the test and initiate the laboratory evaluation, please go to the leadhorizon.org/basic website. We will guide you through the patented testing process. The test consists of two steps:
Please note that we are obliged to register your test results in your country’s national reporting system.

ACTIVATING THE TEST

Before you can take the test, you will need to activate it. To do this, you will need the sample number on the sample tube (1) and your email address. We will send you a link so that you can confirm your email address. To perform the test, you must have an email address because you will be notified when your test result is available.
Providing personal data
In the next step, you can enter your personal data. This data is needed for the evaluation and delivery of your test result. If you would like to know how we process your personal data, please read the privacy policy on our website. You will find it on our log in page.
Proof of identity (not mandatory)
Next, we will ask you to identify yourself. Hold an official photo ID in front of the camera of your smartphone, PC, laptop or tablet, and permit access to your camera. If the scan does not work, you can also enter your ID data manually. Once you have proven your identity, we will then take some photos of you during the test process to make sure that you are doing the test yourself. Only then you will receive a medical report from the partner laboratory and a certificate from LEAD Horizon.

TAKING THE SAMPLE

Sampling
Open the saline solution (2), put it in your mouth, start the timer and then gargle or rinse with the solution – like a mouthwash – for a whole minute. Using the transfer tube (3),spit out the gargle solution into the sample tube (1). Then close it tight with the red cap.
Packing the test set
Now put the following two items in the protective pouch (5): the sealed sample tube (1) and the cellulose (6). Keep these instructions for use in a safe place, as they contain the sample number. You will need this to obtain your test result. Close the protective pouch (5) tightly and put it back in the test box. You can now dispose of f the transfer tube (3) and the saline solution (2).
Returning the test set
The WebApp will inform you directly about how and where to submit your test set.
POSSIBLE TEST RESULTS:
Positive (infected with SARS-CoV-2)
Negative (NOT infected)
Indifferent (no result could be attained)
Your sample will be evaluated by a certified partner laboratory of LEAD Horizon GmbH, using a PCR procedure. You will not receive a test result straightaway after the sample has been taken. The result will only be determined when the sample has been evaluated in the certified laboratory by the PCR procedure. Then it will be made available to you.

IMPORTANT INFORMATION:

No result can be transmitted without you having to register in WebApp.
The WebApp is always up-to-date and may differ from the description in the printed instructions.
The sample is taken by you as a user. Evaluation is performed in the laboratory.
Proof of identity is provided via official photo ID by taking photographs of the medical findings and the certificate.
You will need a computer with a webcam or a smartphone and a stable internet connection.
This is an in vitro diagnostic device.
The cellulose (6) must be placed in the protective pouch (5) for transport purposes.
The most up-to-date version of the instructions for use is available for download (in several languages) at www.lead-horizon.com/downloads.
Stay safe!

STORAGE: Store at 4°C to 25°C.
Best before: see packaging
CONSTITUENTS:

2.5 ml of 0.9% NaCl solution (2)
2 ml transport buffer (1)

PURPOSE: This corona test set is used to detect an infection with the SARS-CoV-2 virus. Sampling is carried out by the user. The molecular biological analysis is conducted by a certified partner laboratory of LEAD Horizon GmbH. The test result will only be sent to the user by email following evaluation in the laboratory.
The corona test set includes a kit for sample collection and sample evaluation by a certified partner laboratory of LEAD Horizon GmbH.
DISPOSAL: