Wn Technical Report /No. A/032/21 TEST KIT EVALUATION TECHNICAL REPORT: BERIGHT - COVID-19 ANTIGEN RAPID TEST DEVICE (Oral Fluid) Lot No. ATCOV21060076, Expiry Date: JUNE 2022 MDA Registration No.:(8)MDA.600.3/1/22 Jid 94 Supplier/Pemohon: Medinics (M) Sdn. Bhd Manufacturer: Hangzhou AllTest Biotech Co., Ltd BY: NATIONAL PUBLIC HEALTH LABORATORY MINISTRY OF HEALTH MALAYSIA Date received: 24 June 2021 Date report: 13 July 2021Test Kit Evaluation Technical Report /No. A/032/21 Table of Content 1.0 Introduction Material and Method.. National Public Health Laboratory, Ministry of Health Malaysia 14Test Kit Evaluation Technical Report /No. A/032/21 4.0 Introduction ‘The Coronavirus disease (COVID-19) is an infectious disease caused by a newly identified coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus is spread by human-to-human transmissions via droplets or direct contact. The availabilty of a cost-effective, rapid point-of-care diagnostic test is oritical to enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus. Antigen tests will play a critical role in the fight against SARS-CoV-2 (COVID-19). ‘The Beright COVID-19 Antigen Rapid Test Device (Oral Fluid) is designed for home users who have symptoms and able to do seff-collection of oral fluid samples. However, this kitis @ preliminary result which requires clinically final confirmation from laboratory diagnostics. The kit is a qualitative membrane-based immunoassay, for SARS-CoV-2 (COVID-19) presence in human oral fluid which contains anti-SARS-CoV-2 antibodies. Two coloured band will show up at the T'region and the C region which became the control of the test. The results were interpretated based on the kit insert. 2.0 Material and Method 24, Test Samples: ‘The evaluation of this Beright COVID-19 Antigen Rapid Test Device (Oral Fluid) was'carried out on. COVID-19 patients sample as positive control and healthy individuals! Sample as negative control. A total of 58 saliva samples from known positive with COVID-19 patients and 50 healthy individual samples were collected. All collected saliva samples were tested with Beright COVID-19) Antigen, Rapid Test (Oral Fluid) and later confirmed with Real Time Polymerase Chain Reaction (RT-PCR). Other underlying diseases or other infectious diseases were not included in this study due to limited resources and time. 2.2 Testkit: ‘The Beright COVID-19 Antigen Rapid Test Device (Oral Fluid) is used for qualitative detection of novel coronavirus (SARS-CoV-2) antigens in human oral fluid samples. Test devices were packed individually which contained collection device such as funnel, tubes and tube tips, buffer and package insert. Test kit with lot number: ATCOV21060076, expiry date: June 2022 was stored at room temperature, 2.3. Test Method: The test was performed in accordance to the manufacturer's instruction as written in the test kit insert. Test interpretations as follows: i. Negative result: A red line, only a red reaction coloured line appears at the quality control area denoted as C. il. Positive result: Two red lines, red coloured lines appear at both test area (T) and quality control area (C). The shade of colour that appears may vary and considered as positive even a faint colour. iii, Invalid result: If a red coloured band does not appear in the control line (C) the result is considered invalid regardless the red line appears at T area. The test 214 tory, Ministry of Health Mala al Public Health LaborTest Kit Evaluation Technical Report No. A/032/21 procedures may not be followed correctly, or the test cassette is deteriorated. Repeat testing is recommended. Ifthe problem persists, discontinue using the kit and contact local distributor. 2.4 — Test Sensitivity and Specificity The Beright COVID-19 Antigen Rapid Test Device (Oral Fluid) results showed that the kit has detected 54/58 SARS-CoV-2 positive sample with sensitivity of 93.10% and 50/50 were tested negative on SARS-CoV-2 negative samples. This gives a specificity of 100.00% for Beright COVID-19 Antigen Rapid Test Device (Oral Fluid). Results are as shown in Table 1 above. Table 1; Results of Beright COVID-19/Antigen Rapid Test Device (Oral Fluid) evaluation, Beright cova igen | Confirmed COVID-19 cases by RT Rapid Test Device (Oral _— Total Fluid) Positive Negative Positive 34 0 4 Negative 4 50 54 Total 58 50 108. 25 Test PPV and NPV The results obtained from this evaluation. also indicated that the Positive Predictive’ Value (PPV) for COVID-19 virus infection was 100,00% (54/54) and the Negative Predictive Value (NPV) was found to be 92.59% (50/54). 3.0 Conclusion The Beright COVID-19 Antigen Rapid Test Device (Oral Fluid) is an in vitro. qualitative detection of novel coronavirus (SARS-CoV-2) antigens in human oral fluid’ specimens from individuals-who meet COVID-19 clinical and / epidemiological criteria. The sensitivity for detection of SARS-CoV-2 viral antigen is 93.10% and the specificity is 100,00%. National Public F lth Laboratory, Ministry of Health Malaysia 34Note: Test Kit Evaluation Technical Report /No, A/032/24 Sensitivity: The ability of the assay under evaluation to correctly detect samples that contain SARS-CoV-2 viral antigen (Reference assay positive) Specificity: The ability of the assay under evaluation to correctly detect samples that do not contain SARS-CoV-2 viral antigen (reference assay negative) PPV: The probability that the sample does contain SARS-CoV-2 viral antigen when the test is positive, NPV: The probability that the sample does not contain SARS-CoV-2 viral antigen when the test is negative. Prepared By: No Reviewed By i i “Approved By: Ms. Che Nur Azni Nazira Bt. Che Nd Mr. Selvanesan AIL Sengol Dr. Hani Binti Mat Hussin Rozi, ‘Science Officer (Microbiology) Director, ‘Science Officcer (Microbiology) Kit Evaluation Technical National Public Health National Public Health Laboratory, _| Coordinator, Laboratory, Ministry of Health Malaysia Head of Virus Isolation & EM Unit, | Ministry of Health Malaysia. Netonal Pubic Heeb Labs, inst of Heath Naas PS] obloea oe Blealan et’ [fren Disclaimer: The institution declares no conflict of interest. The content ofthis report does not imply that this product is endorsed or recommended by the institution. This report may not be reviewed, abstracted, quoted, translated or reproduced without prior return consent of National Public Health Laboratory (NPHL), Ministry of Health Malaysia. NPHL does not allow the use of this report in any ‘manner in the labelling of this product or kt package. National Public Health Laboratory, Ministry of Health Malay 4i4