96 t INSTRUCTIONS FoR UsE Novel cron ns COV. Selection tarecon pense ae g coronavirus Seon FeaNUS(COVIOAS) mucae eis [Product Name} Common wi fame-Nove tection kit ctuorecee [Packing specin: cations tests /kit, 7 Untended Use] Providing molecular dagnosis bans tory nected pet The test results obtai i ined through this kt ret be cone Clncal gress andweatnet he are for clinical he only basis for thatthe elie! Test Principley Moorscenee gente san technology is enpied to eae detocton ghee throu changes tuoescenue see The PER detection system includes endogenous intra “+ positive: ‘control or nests or ce vaining PCR Peactie 9 head with filter ~ element, cover tit Z then move the PCR tube tothe amplification detaction ares. 3.PCR Amplification and Detection Place PCR tubes into fluorescent PCR amplification instru ‘ment (AB! 7500 or ABI VilA 7) for amplification detection, {he robe mode settings areas follows: ORF lab gene Porter Dye: FAM; Guoncher Dye: none): N gene (Reporter Dye: FAM: Guencher Dye: TAMRAY: endogenous controle arranged for PCR tubes for ORF lab gene and N gene (Reporter Dye: HEX (VIC); Guencher Dye: none); {Reporte Dy }: Quencher Dye: none); Passive 4. Recommended cycle parameter settings [Main Components} seo] Neves | Toreraire | — Wins | Racesance This kit comprises fluorescent PCR amplification reaction reyes | Ey ‘ime. ‘acmuisiion | resgents and controle dng ary — Cotorafpite So Seateatsees | [2 [|e ee paccaging bas bi i load copecty = Green Reaction 1 premix 920 "2 ® o ea aosne | ven action premix | __ 97042 ow Reaction 25 ns Note:The sting methods of amsicaon proceso fora Yeaow enzyme 00H tot intruments ay nea tobe sues opie Se (eee he instructions for use of the corresponding nts Transparent | Postve conwat | __ TOOL fects ater setting up PER reactors canbaseaneg oe Transparent | NogetveConuat | __100nL 5. oualty contro [Storage Conditions and Shelf Life] 1. The kit shale stored away from light In a sealed manner, {and the components shall be stored et -2025°C. The shal if of the kit is tentatively set at 6 months Pease reforto the outer. packing bax forthe date of manufacture 2. The kt can be stably stared during the shal ife indicated on the packaging mark. Once used, the amplification reagents can bbe repeatedly frozan and thawed for ro more than 5 times, [Applicable instruments} 'AB| 7500 Real-Time PCR System; ABI ViiA 7 Real-time PCR system, [Sample Requirements] sputum |. Applicable sample types: Tivoat swab and sputum 2. Sample collection: Collect samples according * ‘conventional method. 51 Negative control: no eporier dyes (FAM and e 52 Positive contra ¢ t valuo oF Ct value > 40 for all ndogenous contro! HEX (VIC), : wae © 20 or alrepoaar oe nd endogenous control HEX ¢VIC)), 7 ea 53 The above rex the same ey rogurements must be met atthe sare tine in cari oak otermise, the tests invalid. and needs tone Scanned with CamScannerUreshold line), in gener atypical the ct al, the amplification curve should be S-shaped curve. Judge the test results according to value of the amplification curve and the Tm value of the test sample, so that each parameter meets the requite- ‘ments spectied in the above quality control and then record the qualitative result of the Ct value [cut-off Value} ‘The reference value (Ct of the target gene detected by the kits determined to be 40, and the reference value (Ct of the tendogenous controls determined to.be 40, Linterpretatio: 1. Firstly, analyze whathor there is an amplification curve for the endogenous control (HEX (VIC) reporter dye) (Ct vale © 40). If there ig it moans that this test fe valid end th subsequent analysis can be continued. {A)If typical S-shaped curves are detected for the FAM reporter dyes of ORF Tab gene and N gene (Ct value < 40), the sample is considered positive for COVID-9, B) If no typical S-shaped curve is detected for all FAM report- ler dyes (no Ct value), oF Ct value > 40, the sample is consid= fered negative for COVID-19. ©) If no typical S-shaped curve is detected for the FAM reporter dye of either ORF lab gene or N gene (no Ct value), ‘0 Ct value > 40, the result cannot be judged, and samples ‘need tobe collected again for test. 2.f no typical S-shaped curve is detected for the HEX (VIC) reporter dye of the endogenous control (ne Ct value), or Ct Value > 40, it indicates that the concentration of the test sample is too low or there exist inhibition reaction caused by interfering substances, and samples need to be prepared 20 for tos. 5. Gray zone judgment: the fluorescence signals of a sample {are obviously amplified (FAM reporter dye) but the Ct value > 40, the sample falls within the gray zone, and repeat testing 's required, the result obtained from the repeat testing stil falls within the gray zone, the sample is considered positive for COviD-9, {Limitations of Test Method] 1. The test results obtained through this kit are for clinical ference only, and the clinical diagnosis and treatment of [atonts should be considered comprehensively in combina ‘Son with thei symptoma/signs, medica history, other labore tory examinations and treatment reactions, 2. Analysis ofthe possibilty of false negative results 2iimoroper somo coection honing and war 2 well as low sar syed to face ance Sha slow sample concentration may lead to false nego: 22 The variation of the novel coronavi ‘Buses by other ra the target sequence to bo detected for rus (COVID-19) or sequence changes ors may esto false negative esl 23 Improper preservation of ‘it mi . Binoo ‘het may lead to fase negae 24 Other unvorfed interfering substonces may lead te faioneaatverenta, ne” PER Mbtors ‘rou contanination aun 28 Cros contamination cing samp handing may lad to 28 The clinical uboratory shall be equipped with e wag.onerating personnel in strict accorasene the Good unborn Gone PCR Amplification Teste ‘accordance with the inst -uipment ccordance with tne y Practices tor cna, aEin8. ond shal operate in a {Performance indicators) 1. Specitcty The primers and probes used the ht are des ing tothe conservative sequences of navet {CoviD-9) whch contbutes tothe able rate of th it for the target gen soar no cross eacton wth reste samples ofan Ms HKUI, 2296, OC43), influenza A virus and influenza ve te ntralpostive/negatve references have bees tes and the postve/negatve coincidence rates Td toned accord. corenavi 00d postive genus 2. Limit of Detection (LoD) ‘The Limit of Detection (LOD) of ths kit s 1000 copies/mi. [Precautions] 1. This kit is for in vitro diagnostic use only, please read the Instructions for use earefuly before use, 2, Please be familiar with and master the operation methods and precautions of various instruments to be used before testing, and carry out quality contol for each test Laboratory ‘management should be strictly in accordance with the Good Laboratory Practices for Clinical Gene PCR Amplification Testing, Laboratory staff must be professionally trained. Differ cent stages during the test process should be carried out in different areas. Consumables should be for sinale use after Sterilization Special struments and equinment should be used at each stage ofthe laboratory operation Suppline at iforent Stages in different areas should not be eross-ured 3 All test samplas should be regarded as infectious substances, During the test, working garment and csposable gloves should be worn, and gloves should be replaced Ireqventiy to avoid cross contamination between samples, Sample handling and ‘ste disposal shall conform to the requirements of relevant laws and regulations: General Biosafety Standort for Microb logical and Biomedical Laboratories (WS233-2002) and Medical Waste Management Resultions. 4. The shelf life of the kit will not be affected after 7-day transportation by adding the coolant inte foam box withthe temperature not higher than 20°C. 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