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Logix Smart™ Zika Virus (ZIKV) Test 2021 Logix Smart™ Zika Virus (ZIKV) Test ZIKV-K-004 LOGIX SMART™ ZIKV TEST CO-DIAGNOSTICS, INC. CO-DIAGNOSTICS, INC. | 2401 Foothill Dr., Ste D, Salt Lake City, UT 84109 USA Form Logix Smart™ ZIKV (ZIKV-K-004) Instructions for Use (IVD) TABLE OF CONTENTS 1 Manufacturer and Authorized Representative ..................................................................... 2 2 Intended Use ...................................................................................................................... 2 3 Product Description ............................................................................................................ 2 4 Kit Components .................................................................................................................. 3 5 Storage, Handling, & Disposal ............................................................................................ 3 6 Materials Required (not included) ....................................................................................... 3 7 Background Information ..................................................................................................... 4 8 Accessories (Not Included) ................................................................................................. 5 8.1 Thermocycler ............................................................................................................... 5 8.2 Extraction Kit ................................................................................................................ 5 9 Warnings and Precautions ................................................................................................. 6 10 Sample Information ............................................................................................................ 6 10.1 Sample Storage ........................................................................................................ 7 10.2 Sample Handling ...................................................................................................... 7 11 Procedure .......................................................................................................................... 7 11.1 Real Time RT-PCR Setup ........................................................................................ 7 11.2 No Template Control Set Up..................................................................................... 7 11.3 Patient Sample and Positive Control Set Up ............................................................. 8 11.4 Thermocycler Set Up ................................................................................................ 8 12 Data Analysis ..................................................................................................................... 8 12.1 Positive Controls ...................................................................................................... 9 12.2 No Template Controls............................................................................................... 9 12.3 Interpretation of Results ..........................................................................................11 13 Troubleshooting ................................................................................................................16 13.1 Stability ...................................................................................................................16 13.2 User Errors ..............................................................................................................16 13.3 Invalid Results .........................................................................................................16 13.3.1 Positive Control not amplifying .............................................................................16 13.3.2 No Template Control showing amplification .........................................................17 14 Performance Evaluation ....................................................................................................17 15 Bibliography ......................................................................................................................18 16 Legend of Package Symbols .............................................................................................19 FRM-8624-04 Page 1 of 19 Form Logix Smart™ ZIKV (ZIKV-K-004) Instructions for Use (IVD) 1 MANUFACTURER AND AUTHORIZED REPRESENTATIVE Manufacturer: Co-Diagnostics, Inc 2401 S Foothill Dr. Ste D Salt Lake City, UT 84109 Phone: +1 (801) 438-1036 Email: [email protected] Website: www.codiagnostics.com Authorized Representative: mdi Europa GmbH Langenhagener Str. 71 D-30855 Hannover-Langenhagen Germany Phone: +49 511 39 08 95 30 Email: [email protected] Website: www.mdi-europa.com 2 INTENDED USE The Logix Smart™ Zika Virus test kit is an in vitro diagnostic test, based on qPCR technology, intended for the detection of Zika virus in serum or plasma along with urine. 3 PRODUCT DESCRIPTION The Logix Smart™ Zika Virus test kit is a single-step reverse transcription real-time PCR reaction that can be broken down into 3 stages: sample preparation, reverse transcription, and the polymerase chain reaction with real-time monitoring. It tests the presence or absence of ribonucleic acid (RNA) of Zika Virus in serum or plasma (collected alongside with urine) from patients suspected of Zika fever or Zika disease during acute stages of the disease. Logix Smart™ ZIKV Virus test is recommended to be tested in serum or plasma, alongside with urine (Zika virus testing is essential to aid the control and spread of virus prior to pregnancy, transfusion or transplantation, or sexual relation). The Logix Smart™ ZIKV Virus test detects the virus within 40 cycles from serum, plasma, and urine specimen. Each Logix Smart™ Zika Virus test kit consists of the following components: ➢ Master Mix which is complete and ready for use ➢ Positive Control to verify the performance of the master mix (PC) ➢ Nuclease Free Water to verify there is no contamination in the master mix FRM-8624-04 Page 2 of 19 Form Logix Smart™ ZIKV (ZIKV-K-004) Instructions for Use (IVD) 4 KIT COMPONENTS Table 1: Kit Components Individual Cap Component Symbol Catalog Description Amount Color Number Proprietary blend of Logix Smart™ 1x500µL Brown MM ZIKV-MM-004 co-primers and PCR ZIKV Master Mix (100 reactions) reagents Logix Smart™ Proprietary blend of 1x500µL Red ZIKV Positive PC ZIKV-PC-004 positive primers (100 reactions) Control Water free of Nuclease Free 1x500µL NTC GEN-NF-001 DNase/RNase Water (100 reactions) activity 5 STORAGE, HANDLING, & DISPOSAL ➢ The Logix Smart™ ZIKV Virus kit is shipped on dry ice. The components of the kit should arrive frozen. If one or more of the components are not frozen upon receipt or are compromised during shipment, contact your distributor for assistance. ➢ All components should be stored immediately at or below -20°C to prevent degradation of reagents. ➢ Always work with each Logix Smart™ ZIKV Virus component on ice. Make aliquots, if necessary, to avoid multiple freeze/thaw cycles. ➢ If you work in an area prone to power outages, it is recommended to have a back-up generator for your freezer as well as a temperature data log to ensure that the Logix Smart™ ZIKV Virus test kit remains frozen at -20°C. ➢ Stability data for the product is currently being collected and results will be published and new instructions for use updated to reflect the stability conditions. ➢ The product is not a biological waste. See Safety Data Sheets for hazard classification. Disposal should be in accordance with applicable regional, national, and local laws and regulations. 6 MATERIALS REQUIRED (NOT INCLUDED) ➢ Pipettes capable of transferring 5 µL ➢ Ice ➢ Vortex ➢ Centrifuge ➢ Real-time PCR System with FAM (green) or Cal Fluor 610 (orange) dyes or equivalent and accompanying tubes/plates and caps/films. ➢ The Logix Smart™ Zika Virus Test was validated within CoDx Box MIC manufactured by BioMolecular Systems. It is the recommended equipment to run the test. ➢ Biosafety cabinet, ideally BSL-2 facility. FRM-8624-04 Page 3 of 19 Form Logix Smart™ ZIKV (ZIKV-K-004) Instructions for Use (IVD) Before performing any testing or running any patient sample, verify that all instruments have been properly installed, calibrated, and well maintained. Do not use instruments with outdated calibration. 7 BACKGROUND INFORMATION Zika virus (ZIKV) is a Flaviviridae family virus. It is spread by daytime-active Aedes mosquitoes, such as A. aegypti and A. albopictus. The virus was first isolated in 1947 in monkeys and is named after the Zika Forest in Uganda. In 1952, the first human cases of Zika were detected and since then, outbreaks of Zika have been reported in Africa, the Americas, Asia, and the Pacific. Zika outbreaks have probably occurred in many other locations. Because the symptoms of Zika are similar to those of many other diseases, many cases may not have been recognized or properly reported. Before its emergence in 2015 in Brazil, Zika virus was not thought to be endemically transmitted in the Americas. Since then, it has spread across South and into North America, including the Caribbean. As mentioned above, Zika virus is most commonly transmitted by mosquitoes; nevertheless, horizontal and vertical transmission in humans has been reported. The disease caused by the Zika virus, sometimes called Zika fever, presents with similar symptoms to other arboviral infections such as dengue and chikungunya. The symptoms include
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