User's Guide

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LooK SPOT reader user’s guide

For Use Under the Emergency Use Authorization (EUA) Only

For in vitro Use Only

For use with nasal swab specimens

Rx Only

INTENDED USE

LooK SPOT is a smartphone-based reader to detect the COVID-19 antigen using LooK COVID-19 antigen

cassette based on lateral flow immunoassay. LooK SPOT and LooK COVID-19 antigen cassettes use the

qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from patients

suspected of COVID-19 within the first seven (7) days of symptom onset. The reagent is used to detect the

SARS-CoV-2 nucleocapsid protein antigen, which is usually present in the respiratory tract specimens in the

acute phase of infection. The test result is obtained by inserting the LooK COVID-19 antigen cassette into the

smartphone-based LooK SPOT reader.

When a positive result is presented, it means that there are viral antigens in the specimen, but the patient's

medical history must be combined with other clinical data to assess the infection status; a positive result

cannot exclude bacterial infection or co-infection with other viruses, and the detected pathogen may not be

the main reason of the disease.

Negative results cannot completely rule out SARS-CoV-2 infection, so this product should not be used as the

only basis for treatment or management decisions (including infection control); negative results should be

comprehensively evaluated based on the patient's contact history, medical history, signs and clinical

symptoms, necessary at times, molecular diagnosis (RT-PCR) is used to confirm the diagnosis and serve as a

basis for patient management. The LooK COVID-19 antigen cassette does not differentiate between SARS-

CoV and SARS-CoV- 2.

LooK COVID-19 antigen rapid test is for use at the Point of Care (POC) settings by medical or trained

professionals who perform rapid lateral flow tests. It is only for use under the Food and Drug

Administration's Emergency Use Authorization.

SUMMARY

The SARS-CoV-2 virus is a positive-stranded single-stranded RNA virus with an envelope with a virus particle

diameter of about 50～200nm; it is composed of four main structural proteins: spike protein (S), envelope

protein (E), membrane protein (M) and nucleocapsid protein (N). The nucleocapsid protein binds to the viral

RNA, and the other three proteins together form the viral coat. Its gene sequence is similar to SARS and

MERS viruses, but they belong to different species.

The incubation period of the SARS-CoV-2 is about 2-14 days on average; most patients will have respiratory

symptoms. Typical symptoms include frequent fever, dry cough, weakness of limbs, etc. (may be

accompanied by muscle pain, diarrhea, sore throat, loss of smell and abdominal pain, etc.). There is a

percentage of carriers without any clinical symptoms. Severe patients may develop acute respiratory distress

syndrome (ARDS), septic shock, diffuse alveolar injury, or even death. SARS-CoV-2 virus has spread globally.

LooK COVID-19 antigen rapid test is an immunochromatographic test that uses monoclonal antibodies

combined with latex particles to detect whether there are SARS-CoV-2 antigens in nasal secretions. This

reagent is not only easy to execute, and the test result can be ready within five (5) minutes with the use of

LooK SPOT reader and a smartphone with LooK SPOT app.

Summary of content (15 pages)

PAGE 1
LooK SPOT reader user’s guide For Use Under the Emergency Use Authorization (EUA) Only For in vitro Use Only For use with nasal swab specimens Rx Only INTENDED USE LooK SPOT is a smartphone-based reader to detect the COVID-19 antigen using LooK COVID-19 antigen cassette based on lateral flow immunoassay.
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TEST PRINCIPLE LooK COVID-19 antigen immunochromatographic detection reagent uses a rapid immunochromatographic detection method to detect whether the nucleocapsid protein antigen of the SARS-CoV-2 virus is present in the nasal swab samples using specific monoclonal antibodies. LooK COVID-19 antigen cassette reagent is designed to detect whether patients who are suspected of being infected by SARS-CoV-2 virus have the SARS-CoV-2 antigen in their nasal swabs.
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7. The Extraction Buffer Tube contains a saline solution and sodium azide, which is harmful if inhaled, swallowed, or in contact with the skin. Contact with acidic substances may produce highly toxic gas. If you accidentally touch your skin, please rinse immediately with plenty of water. Sodium azide may react with lead or copper pipes to form explosive compounds. Therefore, it is recommended to rinse with plenty of water to avoid the accumulation of azide. 8.
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Fig. 1 Fig. 3 Fig. 2 If the size of your smartphone is too big or too small to fit into the guide rail, please remove the guide rail and use the double side adhesive strip provided in the packaging. Align the lens with the camera properly and press the LooK SPOT reader with the smartphone. This method can also be applied to smartphones using protective cases. Fig. 5 Fig. 4 Fig.
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1. With the LooK SPOT reader attached to the smartphone, open the smartphone’s camera app and look for the cross mark. The cross mark must be in the center of the screen for the test. If the smartphone has multiple cameras, this step will ensure the correct camera is used for the LooK SPOT reader. Fig. 7 2. Open LooK SPOT app. Press the X mark of "LooK SPOT reader connected" to see the available LooK SPOT within the Bluetooth signal range.
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4. The screen will show the view of the calibration cassette and a rectangle box. Use your index finger to move the rectangle box to cover the test window of the calibration cassette. Press Confirm to finish this calibration process. Fig. 12 Fig. 11 5. The screen now shows "Camera Calibrated" checked. Remove the calibration cassette and be ready for the COVID-19 antigen test. Fig. 13 The above process is important to obtain the correct test result for Look COVID-19 antigen test.
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Built-in Procedural Controls The images of the LooK COVID-19 antigen cassette taken from the LooK SPOT app with LooK SPOT reader are sent to LocationNow AI cloud for analysis and diagnosis. LocationNow AI Cloud has a built-in procedural controls process to detect positive, negative, or invalid test results. Each image is associated with Look COVID-19 antigen cassette built-in microchip. This microchip is associated with the unique QR code on the back of each LooK COVID-19 antigen cassette.
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For example: Using an unknown third party or used antigen cassette. LocationNow AI Cloud will alert immediately as an unknown antigen cassette. Fig. 16 The test results are documented automatically in the History section of LooK SPOT app with the Test ID, location, city, country, and timestamp of the tests. If the test did not flow correctly, the test result would show Invalid. The operator can also request the cause for the invalid test result to be delivered by email.
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External Positive and Negative control swabs are included in the shipment and should be tested using the swab test procedure provided in the Instruction of Use. If the correct control results are not obtained, do not perform patient tests. Contact Laipac Technology, Inc. Customer Service for assistance Monday through Friday from 9:00 a.m. to 6:00 p.m. Eastern Time at 905-7621228; info@laipac.com or your local distributor. Additional External Control Swabs may be obtained separately.
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2. Leave the swab in the Extraction Buffer Tube for 1 minute. Roll the swab head against the inside of the Tube as removing it. Dispose of the used swab in biohazard waste. 3. Fill the disposable dropper with the patient sample from the Extraction Buffer Tube: a) Squeeze the bulb. b) Still squeezing, place the dropper tip into the patient sample. c) Slowly release the pressure on the bulb to fill the dropper 4.
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3. After performing the Look SPOT Reader Calibration Check Procedure, insert the test cassette to LooK SPOT reader. LooK SPOT reader will detect the valid test cassette with the embedded microchip inside the test cassette. Then press the tab "Proceed to Detect SARS-CoV-2" on the screen. The timer will appear to count the time for the diagnosis process. Please leave the LooK SPOT reader on a flat surface and make sure the cassette in the correct position and not moving.
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4. The test result will be ready in 5 minutes on the LooK SPOT app screen. The results can be Positive, Negative, or Invalid. For an invalid test result, please discard the test cassette in the biohazard waste and redo the test again. Fig. 24 Fig. 23 Fig. 25 5. Remove the test cassette and dispose of it in biohazard waste. LooK SPOT reader will sterilize automatically with an internal UV light of 260nm wavelength for 10 seconds and ready for the next test. Fig.
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LIMITATIONS 1. This product qualitatively detects whether the nasopharyngeal swab sample has the SARS-CoV-2 virus antigen. 2. Failure to use this product in accordance with standard operating procedures may affect product performance and produce invalid results. 3. The sample should be tested as soon as possible after collection. 4. As the number of days of the disease course increases, the number of viral antigens in the sample may decrease.
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Cet appareil est conforme aux normes RSS sans licence d’Industrie Canada. Son fonctionnement est soumis aux deux conditions suivantes: (1) Cet appareil ne doit pas provoquer d'interférences; et (2) Cet appareil doit accepter toute interférence, y compris les interférences susceptibles d'entraîner un fonctionnement indésirable de l'appareil. RF Radiation Exposure Statement: 1.
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• EMC Directive 2004/108/EC; • RoHS II Directive 2011/65/EU. REFERENCES "How to Protect Yourself & Others". Centers for Disease Control and Prevention (CDC). 8 April 2020. Archived from the original on 26 February 2020. Retrieved 9 April 2020. 2. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. U.S. Department of Health and Human Services, CDC, NIH, Washington, DC (2007). 3. D. B. Larremore et al.