INSTITUT KESIHATAN NEGARA NATIONAL INSTITUTES OF HEALTH (NIH) KEMENTERIAN KESIHATAN MALAYSIA INSTITUT PENYELIDIKAN PERUBATAN (IMR) ‘Aras 6, Blok C6 Not Jalan Setia Murni 13/52 Seksyen U13 Setia Alam Telefoni : 603-8362 7900 40170 SHAH ALAM, SELANGOR Faksimili_: 603-3362 7901 Ruj.kami: IMRIIDRC/VIRO(SA)/2301/23/01(167) Tarikh: & Julai 2021 Citymedic Sdn. Bhd. (928717-W) No. 3, Jalan Lagenda 3, Taman 1-Lagenda, 75400 Melaka. Tuan, LAPORAN UJIAN PENILAIAN KIT NOVEL CORONAVIRUS (COVID-19): GMATE® COVID-19 AG SALIVA FOR HOME USE Dengan segala hormat merujuk kepada perkara di atas. 2. Adalah dimakiumkan bahawa pihak kami telah menjalankan ujian_penilaian terhadap kit novel Coronavirus (2019-nCoV) fest kit seperti yang dimohon oleh pihak tuan. 3. Bersama-sama ini dikemukakan laporan bertajuk Performance of. Gmate® COVID-19 Ag Saliva for Home Use, Manufacturer: Philosys Co., Ltd., Korea untuk perhatian dan rujukan pihak tuan. Sekian, terima kasih. “PRIHATIN RAKYAT : DARURAT MEMERANGI COVID-19” “BERKHIDMAT UNTUK NEGARA” Saya/fang Menjalankan amanah, wy (OR. HAJI TAHIR BIN ARIS) MPM: 28418 NSR: 127511 Pengarah Institut Penyelidikan Perubatan (IMR) 8 03 ~ 3362 8906 2 tahir.a@moh.gov.my Sk: En. Ahmad Shariff Bin Hambali Ketua Eksekutif Pihak Berkuasa Peranti Perubatan (Medical Device Authority) Aras 5 & 6, Prima 9, Prima Avenue Il, Blok 3547, Persiaran Apec, 63000 Cyberjaya, SelangorINSTITUTE FOR MEDICAL RESEARCH KUALA LUMPUR EVALUATION TEST REPORT OF COVID-19 ANTIGEN RAPID TEST DEVICE (SELF-TEST) Medical Device Name : Gmate® COVID-19 Ag Saliva for Home Use Establishment Name : CiyMedic Sdn. Bhd Intended use. ‘This product is intended to support for in vitro qualitative detection to SARS-CoV-2 antigen in human saliva samples for home use. Manufacturer Philosys Co., Ltd, Korea. Test Principle This kit is developed based on gold immunochromatographic test. When the antigen is contained in the sample, the antigen binds with the gold labelled monocional antibody to form a compound, moving forward under’ the chromatography, then combines withthe coated antibody inthe test ine, indicating a positive result. Ifthe sample does. ‘not contain antigen, complex cannot be formed inthe test Ine, itindicates negative result. Whether the samples contain antigens or not, the gold labelled monoclonal antibody will combine with the coated goat ant-mouse IgG antibody at ‘the quality control line. Test Kit Lot Number : CS10UFAO Expiry Date : 31 May 2023, Batch mp./Idenfifier: AG-020 Instrument Used NA Reagent and Sample Preparation, Result Interpretation Kindly refer to product package insert inthe attachment ‘Sample Used ‘Sample type = Saliva Known Negative Sample= 42 Total samples used for analysi Performance Analysis a aay —] Fa ss cag — SARS-CaT Pos COMET | aE 5 panel | eaRS CAVE Negave COD] —O a mee ‘The performance of this kit was compared with saliva samples collected from same patients. Positive samples were selected if saliva samples were tested positive using RT-qPCR test system and the Ct values were ranged from 22 to 30. The saliva samples collected from patients and virology staff, IMR that tested negative using COVID-19 RT-qPCR: test system was selected as negative samples. A survey was conducted to assess the level of understanding to perform this homo based COVID-109 test kit among the selected participants. The findings show that, 05.3% of tho participant ‘corresponded that their level of understanding to perform this testis good. 98.8% of participants had agreed that the test kit instruction is easy to understand, the collection of saliva samples can be performed easly, and the interpretation Of test results very straightforward. Suggestion to attach a quick user guide in Bahasa Melayu version @ ‘Test performed by cle Pn. €.Kavithambigai AP Elan | Pn. Muri Maya Sari Dr. Hj, Tahir bin As Evaluator 1/Oficerin charge | Evaluator 21fce in charge Direcor of IMR camer The content of his report does not imply that this produc is endorsed or recommended by the Insitute for Medical Research (IMR) ‘This repor may not be reviewed, abstracted, quoted, reproduced or anlated, in part orin whole, without the prior wien permission OofIMR. IMR does no allow the use ofthis repor or reference in any manner in te labeling or advertising of ths product ork package. However, the permission to impor, export, or place inthe markets subject to Medical Device Authority, Ministry of Health Malaysia's approval.