Laboratory diagnostics of COVID-19 in Donetsk and Luhansk GCA

Artem Skrypnyk WHO Country Office in Ukraine COVID-19 diagnostics in Ukraine: a) point-of-care

• Rapid antigen tests (Ag-RDTs) – easy to use, cheap, widely used by hospitals, private practitioners. Potential problems with reporting. • Ag-RDTs currently in use in Ukraine incl GCA – WHO EUL prequalified – very good specificity and sensitivity • Other Ag-RDTs may have suboptimal specificity and sensitivity – always look at the prequalifications • Antibody RDTs (Ab-RDTs) – not in use currently due to low diagnostic value characteristics – currently not recommended by WHO COVID-19 diagnostics in Ukraine: a) point-of-care

• Cepheid GeneXpert – point-of-care PCR platform • Not in use for COVID-19 in Ukraine • Used for TB / AMR TB • Comparatively expensive COVID-19 diagnostics in Ukraine: b) laboratory based

• Antibody testing (ELISA) is not recommended by WHO for COVID-19 diagnostics • May be used for epidemiological studies or to check Abs after vaccination COVID-19 diagnostics: Real-Time Polymerase Chain Reaction (RT-PCR)

• RT-PCR is the main method for laboratory SARS-COV-2 identification • Three steps (may be different manufacturers): – Sample collection and transportation (pre-analytical stage) – Nucleic acid extraction – Real-Time PCR • RT-PCR may be conducted within one working day

• 75% of errors happen at pre-analytical stage COVID-19 lab diagnostics: WHO support to GCA

• WHO CO supported procurement to launch PCR lab at Luhansk OLC (Severodonetsk) in autumn 2019 – fully operational since the pandemic beginning • WHO CO supported procurement of PCR lab for Donetsk OLC (Kramatorsk) in summer 2020 (DG NEAR funds) – fully operational since September 2020 • Equipment: thermocyclers, biosafety cabinets, centrifuges, dry-blocks, pipettes, etc. • PCR and extraction kits • Lots of consumables (PCR plates, filter tips, PCR tubes, PCR strips, etc.) COVID-19 lab diagnostics: WHO support to GCA • PCR trainings: – Luhansk OLC in Severodonetsk - July 27-29, 2020 – 14 trainees – Mariupol City Branch of Donetsk OLC - July 20-22, 2020 – 10 trainees – Donetsk OLC in Kramatorsk - September 21-26, 2020 – 20 trainees (Kramatorsk, Toretsk, Dobropillia, Kostiantynivka city branches) – Donetsk HIV Center in Sloviansk - January 10-15, 2021 – 14 trainees (Kramatorsk, Toretsk city branches, Kramatorsk City Hospital No 3)

• Biosafety and biosecurity trainings (twinned with PCR): – Donetsk OLC in Kramatorsk – September 21-26, 2020 – 20 trainees – Donetsk HIV Center in Sloviansk – – January 10-15, 2021 – 14 trainees COVID-19 lab diagnostics: WHO support to GCA

• Lab assessments using WHO COVID-19 Lab Assessment Tool as of 28 April 2021: – Luhansk OLC in Severodonetsk – Mariupol City Branch of Donetsk OLC – Donetsk OLC in Kramatorsk – Donetsk HIV Center in Sloviansk – Toretsk City Branch of Donetsk OLC – Private lab Kod Zdorovya in Mariupol COVID-19 lab diagnostics: WHO support to GCA

• WHO conducted a large scale External Quality Assurance (EQA) exercise globally • 133 labs participated from Ukraine • 6 labs from Luhansk and Donetsk GCA • All 6 gain excellent results COVID-19 diagnostics in GCA: snapshot • Many labs conduct COVID-19 RT-PCR in GCA : • Luhansk GCA: – Luhansk Oblast Lab Center (Severodonetsk) – 2 private labs in Luhansk – Labs in hospitals • Donetsk GCA: – Donetsk Oblast Lab Center (Kramatorsk) – Toretsk City Branch of Donetsk OLC – Mariupol City Branch of Donetsk OLC – Mariupol Dermato-venerological Dispensary – Mariupol City Hospital No 4 – Private lab Kod Zdorovya in Mariupol – Bakhmut City Hospital (newly opened) COVID-19 lab diagnostics in GCA: snapshot

• Main work horses: – OLC in Kramatorsk – OLC in Severodonetsk – Donetsk HIV Center (in Sloviansk) – rather small but heavy duty lab which took the first waves until launch of PCR lab in Kramatorsk – Toretsk City Branch – operational since September 2020 – Mariupol City Branch – operational since May 2020 – requires support – Mariupol Hospital No 4 COVID-19 lab diagnostics in GCA: snapshot

• COVID-19 testing system is operational in GCA and adapted after the initial shock • Equipped and capable to process the number of samples they currently receive • Staff has experience • Staff surge plans are in place • MOH labs have some budgets for procurement • MOH labs receive some reagents from Kyiv COVID-19 lab diagnostics in GCA: needs • However • More investments and support are needed as • Contact tracing should be revitalized -> significant increase of samples which will need to be processed • Infrastructure (buildings, vehicles, furniture, etc) is pretty old – Sloviansk HIV Center should be moved to a bigger premises – Mariupol Branch – very bad condition of the building – should be moved to the new premises – Toretsk Branch – renovation should be conducted – extremely cold in winter – HVAC systems are absent in all labs – Old wooden windows, doors, floors, etc. – Electric wiring is old COVID-19 lab diagnostics in GCA: needs • Still not enough equipment – labs are not ready for the significant increase of samples – Thermocyclers – Automated extractors – Biosafety cabinets (Mariupol Branch - acute) plus certifications – Autoclaves should be replaced everywhere – they use 30 years old Soviet (outdated technologies, DANGEROUS) – big problem (modern autoclaves are expensive) – Electric generators / electric grids – Pipettes – Laboratory furniture is extremely old – Lab freezers (-70, -20, +4) COVID-19 lab diagnostics in GCA: needs • Laboratory Information System (LIS) may help to optimize the data management and is able to significantly speed up the turn around (bar codes instead of manually filled papers) • Reagents are very much needed (quality!) – RT-PCR kits, – extraction kits • Consumables – great need! – Filter tips – PCR plates – Deepwell plates for extractions, – etc. COVID-19 lab diagnostics in GCA: needs

• In Ukraine, as well as in GCA labs there is significant lack of staff • Salaries are small, premia are not stable and not all workers receive it • Not attractive conditions • More trainings (refreshments and initial trainings for new staff) are needed on – Biosafety and biosecurity – PCR – Quality assurance Thank you!

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