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Draft on Testing for COVID-19 with Antibody and PCR Tests in Low Resource Areas
- 1. OUR RESPONSE TOCOVID-19 AGHAM AT KAALAMAN PARA SA BAYAN! OFFICERS Gisela P. Concepcion, PhD PRESIDENT Edsel A. Peña, PhD VICE-PRESIDENT Lourdes Herold, PhD SECRETARY Anna Kristina Serquiña, MD PhD TREASURER BOARD OF DIRECTORS Carlito Lebrilla, PhD CHAIRPERSON Rigoberto Advincula, PhD Diana Aga, PhD Joel Cuello, PhD Alvin Culaba, PhD Lawrence Ilag, PhD Marjorie Peña, PhD Mariano Sto. Domingo, PhD Eizadora Yu, PhD MEMBERS PAASE hosted bv PAASE Philippines, Inc. A SUBSIDIARY OF PAASE Marine Natural Products & Biotechnology Laboratories The Marine Science Institute Velasquez St. University of the Philippines Diliman, Quezon City E-MAIL gpconcepcion@gmail.com paase2020manila@gmail.com WEBSITE www.paase.org PAASE BULLETIN # 11 ON PAASE STRATEGIC ACTION GROUP 3: MASS TESTING & FAST-TRACKING Addressed to: DOH and COVID-19 IATF A 3-STEP RECOMMENDATION FOR DIAGNOSTIC TESTING USING ANTIBODY AND PCR TESTS IN LOW-RESOURCE AREAS PAASE recommends the following algorithm for COVID-19 diagnostic testing using antibody and/or PCR tests to be used by healthcare workers in low-resource areas. A. Challenges in COVID-19 diagnostics The current guideline tests only those exhibiting moderate to severe symptoms. Unfortunately, this misses those with mild symptoms and infected asymptomatics who may be spreading the disease unknowingly. Frontline healthcare workers (HCW) are not getting the benefit of testing (unless they exhibit moderate to severe symptoms) as they perform their work caring for COVID-19 patients. B. Recommendations 1. We recommend enhanced testing to include patients under investigation (PUI) and patients under monitoring (PUM) and all suspected to be exposed, regardless of whether or not they show symptoms. Positives must be isolated, monitored and treated. Contact tracing must follow a positive test and contacts must also be monitored. This informs a more targeted quarantine and will play a role in the government’s actions post-lockdown. 2. Our healthcare workers must also be supported with regular testing even if they do not show symptoms, using either or both antibody and PCR tests, if possible. 3. Antibody testing can augment our currently limited testing capacity. Some antibody tests can give rapid results, are inexpensive and will help in places that have little or no access to PCR testing. We provide step-by-step guidelines on the use and utility of antibody tests by themselves in low- resource areas and in combination with PCR. 4. With or without testing, using PCR, antibody or both, we recommend that clinicians use disease presentation and their best judgment for patient management. C. Rationale 1. Cost The RT-PCR test for COVID-19 is estimated to cost up to 3,500 pesos, which includes test reagents, manpower, equipment and PPEs. The cost of rapid diagnostic tests for detection of antibodies against SARS-CoV-2 (IgM and/or IgG) is estimated to be less than 1/5th the cost of PCR. 2. Time Rapid diagnostic (antibody) testing may take as little as 15 minutes individually, while PCR testing can take from 2 to 4 hours to run (sometimes in batches, requiring waiting for other samples to be ready). 3. Facilities and Expertise PCR testing is performed under specialized laboratory facilities by highly trained (e.g., biochemistry, molecular biology) personnel. The rapid diagnostic (antibody) tests, however, may be done in a point-of-care setting by a trained healthcare worker such as a physician.
- 2. OUR RESPONSE TOCOVID-19 AGHAM AT KAALAMAN PARA SA BAYAN! OFFICERS Gisela P. Concepcion, PhD PRESIDENT Edsel A. Peña, PhD VICE-PRESIDENT Lourdes Herold, PhD SECRETARY Anna Kristina Serquiña, MD PhD TREASURER BOARD OF DIRECTORS Carlito Lebrilla, PhD CHAIRPERSON Rigoberto Advincula, PhD Diana Aga, PhD Joel Cuello, PhD Alvin Culaba, PhD Lawrence Ilag, PhD Marjorie Peña, PhD Mariano Sto. Domingo, PhD Eizadora Yu, PhD MEMBERS PAASE hosted bv PAASE Philippines, Inc. A SUBSIDIARY OF PAASE Marine Natural Products & Biotechnology Laboratories The Marine Science Institute Velasquez St. University of the Philippines Diliman, Quezon City E-MAIL gpconcepcion@gmail.com paase2020manila@gmail.com WEBSITE www.paase.org D. Summary of Guidelines 1. Step 1: Frontline healthcare workers and their local government units follow the decision tree according to availability of resources. 2. Step 2: Patients are triaged according to disease phase by their clinical presentation. 3. Step 3: The following are the recommended tests for each phase (using tests that have adequate specificity and sensitivity, and strictly following manufacturer’s instructions) a. Phase 0 and 1: antibody test followed by PCR b. Phase 2: antibody test (confirm negative results with PCR) c. Phase 3: antibody test 4. If a test for viral antigens become approved for commercial use, treat it as similar to a PCR but with potentially lower specificity and sensitivity (i.e., more results that are false negatives and false positives). 5. Testing healthcare workers regularly and repeatedly can be carried out with the antibody test because their exposure is constant. E. Limitations and Challenges of Antibody Testing 1. Accuracy of antibody tests are not fully known. 2. Accuracy may vary greatly among antibody tests. 3. Some antibody tests fail to distinguish between IgM and IgG. 4. New antibody tests are becoming available even before FDA approval. 5. Newer antibody tests may be more accurate than FDA-approved ones. Validation is challenging for all of the above reasons; hence, we recommend: 1. DOH/FDA validate the manufacturer-provided accuracies of antibody tests being introduced, and approve/endorse only the good performers; 2. Clinicians to interpret the results vis-a-vis clinical presentation; 3. Use the tests strictly according to manufacturer’s instructions to minimize results variability. 3-Step Recommendation for Diagnostic Testing The figures below provide a guide for the steps in the process that can be used by healthcare workers. Depending on the accessibility of tests, the HCW may proceed using Step 3a or 3b. Prepared by: Salvador Eugenio C. Caoili, M.D., Ph.D. and Romulo de Castro, Ph.D. E-mail: badong@post.upm.edu; rdcastro@usa.edu.ph Mobile: SECC (0917) 5861444, RdC (0995) 956 6505
- 3. Step 1: DecisionTree for Low-Resource Situation
- 4. Step 2: Evaluationand Triage
- 5. Step 3a: Ifonly Rapid Diagnostic (Antibody) Tests are Available
- 6. Step 3b: IfBoth Rapid Diagnostic (Antibody) and PCR Tests are Available
- 8.
- 9. OUR RESPONSE TOCOVID-19 AGHAM AT KAALAMAN PARA SA BAYAN! OFFICERS Gisela P. Concepcion, PhD PRESIDENT Edsel A. Peña, PhD VICE-PRESIDENT Lourdes Herold, PhD SECRETARY Anna Kristina Serquiña, MD PhD TREASURER BOARD OF DIRECTORS Carlito Lebrilla, PhD CHAIRPERSON Rigoberto Advincula, PhD Diana Aga, PhD Joel Cuello, PhD Alvin Culaba, PhD Lawrence Ilag, PhD Marjorie Peña, PhD Mariano Sto. Domingo, PhD Eizadora Yu, PhD MEMBERS PAASE hosted bv PAASE Philippines, Inc. A SUBSIDIARY OF PAASE Marine Natural Products & Biotechnology Laboratories The Marine Science Institute Velasquez St. University of the Philippines Diliman, Quezon City E-MAIL gpconcepcion@gmail.com paase2020manila@gmail.com WEBSITE www.paase.org References 1. Centers for Disease Control and Prevention (2020) Coronavirus Disease 2019 (COVID-19) Clinical Care. Retrieved 5 April 2020 from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance- management- patients.html. 2. Philippine Society for Microbiology and Infectious Diseases (2020) Interim Guidelines on the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection Version 2.1, as of 31 March 2020. 3. Li L, Liu W, Zheng Y, Jiang X, Kou G, Ding J et al. (2020) A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in 238 admitted hospital patients. medRxiv. doi: 10.1101/2020.03.06.20031856. 4. Pan Y, Li X, Yang G, Fan J, Tang Y, Zhao J et al. (2020) Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients. Medrxiv. Retrieved from: https://www.medrxiv.org/content/10.1101/2020.03.13.20035428v1.full.pdf. 5. PharmACT Holding AG Inc. (2020) SARS-CoV-2 Rapid Test. Retrieved from: https://pharmact-health.com/en/sars-cov-2-rapid-test/. 6. Seegene (2020) Seegene All-Plex Test - 2019-nCoV multiplex real-time PCR assay for simultaneous detection of 3 target genes of SARS-CoV-2. Retrieved from: www.seegene.com. 7. World Health Organization (2020) WHO-China Joint Mission on Coronavirus Disease 19 (COVID-19). Retrieved 5 April 2020 from: https://www.who.int/docs/default- source/coronaviruse/who-china-joint- mission-on-covid-19-final-report.pdf. Salvador Eugenio C. Caoili, M.D., Ph.D. and Romulo de Castro, Ph.D. E-mail: badong@post.upm.edu; rdcastro@usa.edu.ph Mobile: SECC (0917) 5861444, RdC (0995) 956 6505