INTERPRETATION OF RESULTS 
Nanjing Liming Bio-Products Co., Ltd. No. 12 Huayuan Road, Nanjing, Jiangsu, 210042 P.R. China. Tel: +86(25) 85288506 Fax: (0086)25 85476387 E-mail: sales@limingbio.com Website: www.limingbio.com Technical support: poct_tech@limingbio.com Product packagingAntigen Rapid Test leaflets(20200713)COVID-19 Antigen kitSARS-CoV-2 Antigen Rapid Test German Manualsaliva sars-cov-2 Antigen clinical study(Swab)SARS-CoV-2-Antigen-Rapid-Test（Anterior-nasal-swab）
The product has an exclusive agent in New Zealand. If you are interested in purchasing, the contact information is as follows: Mick Dienhoff General Manager Phone number: 0755564763 Mobile number: 0492 009 534 E-mail: enquiries@nzrapidtests.co.nzINTENDED USE StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette employs immunochromatography technology to detect the SARS- CoV-2 nucleocapsid antigen in human anterior nasal swab specimen. This testis single use only and intended for self-testing. It is recommanded to use this test within 5 days of symptom onset. It is supported by the clinical performance assessment. INTRODUCTION The novel coronaviruses belong totiie p genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel cxjronavinis are the main source of infection; asymptomatic infected people can also be an infectious source. Based on 1he current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. PRINCIPLE The StrongStep® SARS-CoV-2 Antigen Test employs immunochromatographic test. Latex conjugated antibodies (Latex-Ab) corresponding to SARS-CoV-2 are dry-immobilized at the end of nitrocellulose membrane strip. SARS-CoV-2 antibodies are bond at the Test Zone (T) and Biotin-BSA is bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the latex conjugate. If present in sample, SARS-CoV-2 antigens will bind with the conjugated antibodies forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by SARS-CoV-2 antibodies generating a visible red line. If there are no SARS-CoV-2 antigens in sample, no red line is formed in the Test Zone (T). The streptavidin conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the Biotin-BSA aggregating in a blue line, which indicates the validity of the test. KIT COMPONENTS 1 test/box；5 tests/box： | Sealed foil pouch packed test devices | Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions. |
| Dilution Buffer vials | 0.1 M Phosphate buffered saline (PBS) and 0.02% sodium azide. |
| Extraction Tubes | For specimens preparation use. |
| Packs of swab | For specimen collection. |
| Workstation | Place for holding buffer vials and tubes. |
| Package insert | For operation instruction. |
| 20 Individually packed test devices | Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding reqions. |
| 2 Extraction Buffer vials | 0.1 M Phosphate buffered saline (P8S) and0.02% sodium azide. |
| 20 Extraction tubes | For specimens preparation use. |
| 1 Workstation | Place for holding buffer vials and tubes. |
| 1 Package insert | For operation instruction. |
MATERIALS REQUIRED BUT NOT PROVIDED
| Timer | For timing use. |
| Any necessary personal protective equipment |
- Read the instructions carefully before performing the test.
- This product does not contain any human source materials.
, Insert one swab into one nostril of the patient. The swab tip should be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected.
• Use the same swab, repeat this process for tha other nostril to ensure that an adequate sample is collected from both nasal cavities.
It Is recommended that specimens be processed as soon as possible after collection. Specimens can be held in container uptol hour at mom temperature (15°C to 30"C), or up to 24 hours when rsfrigeratod (2°C to 8eC) before processing.
PROCEDURE Bring test devices, specimens, buffer and/or controls to room temperature (15-30°C) bafore use. ♦ Plac® the collected specimen Extraction tube in the designated area of the workstation. ♦ Squeeze all the Dilution Buffer into the ext radion tube. ♦ Put the specimen swab into the tube. Vigorously mix the solution by rotating the swab forcefully against the side of the tube for least 15 times (while submerged). Best results are obtained when the specimen is vigorously mixed in the solution. ♦ Allow the swab to soak in the Extraction Buffer for one minute prior to the next Step. ♦ Squeeze out as much liquid as possible from the swab by pinching the side of the flexible extraction tube as the swab is removed. At least 1/2ofttie sample buffer solution must remain in the tube for adequate capillary migration to occur. Put the cap onto ihe extracted tube. ♦ Discard the swab in a suitable biohazardous waste container. ♦ The specimens extracted can retain at room temperature for 30 minutes without affecting the result of the test. ♦ Remove ths test device from its sealed pouch, and place it on a dean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within 30 minutes. ♦ Add 3 drops (approximately 100 pL) of extracted sample from the Extraction Tube to the round sample well on the test device. Avoid trapping air bubbles In the sample well (S), and do not drop any solution In observation window. As the test begins to work, you will see color move across the membrane. ♦ Wart for the colored band(s) to appear. The result should be read by visual at 15 minutas. Do not interpret the result after 30 minutes. • Put the test tube containing the swab and the used test device Into theattached biohazard bag and seal it, and then discard it in a suitablebiohazard waste container. Then throw away the remaining Items • Wash your hands or reapply hand sanitizer. Discard used Extraction Tubes and Test Devices in suitable biohazardous waste container.