Covid-19 Test PCR Tool Starts Production

Covid-19 Test PCR Tool Starts Production

The Ministry of State-Owned Enterprises (BUMN) said that the COVID-19 assay based on Polymerase Chain Reaction (PCR) made by PT Bio Farma (Persero), namely BioCov-19 began to be produced.

"So far we have imported reagents (raw materials for PCR tests), and we can now produce them. Bio Farma has begun to work on this," said Special Staff to the Minister of SOEs Arya Sinulingga.

He said the production capacity of PCR diagnostic kits (BioCov-19) at Bio Farma was 200,000 test kits per month or around 50,000 test kits per week.

He added that the capacity might be enlarged by adding automated equipment to carry out the production process, while currently at Bio Farma it is still manually using operators with a total of 15-18 people.

Arya hopes that Bio Farma's success in making the PCR diagnostic kit will encourage the local pharmaceutical industry to continue to grow.

"So, the SOE Ministry continues to encourage the local pharmaceutical industry to develop and local products to be added," he said.

Explained, PT Bio Farma made a PCR diagnostic kit that was specific to SARS-CoV-2 or COVID-19 and continued to refer to the WHO-CDC Protocol for Emergency Use, using 3 recommended gene targets, namely Gene RdRP (RNA dependent RNA Polymerase), Nucleocapsid gene (Gene N), and Gene RNase-P (RPP30) as human gene control.

Delivered, the kit produced by PT Bio Farma has been tested preliminary to determine its sensitivity and specificity. This preliminary test is carried out by the Nusantics Team and will be repeated by the PT Bio Farma team.

Sensitivity is the lowest detection limit (LoD / Limit of Detection) that can be detected by a kit, usually the unit for the RT PCR Kit is the Copies number, this shows how many copies of the viral gene that can be detected by this kit.

"The smaller the number the more sensitive the kit is made," he explained.

While Specificity is the ability of the kit to distinguish target virus genes from other similar viruses. So if RT PCR is designed to detect COVID, it will only detect covid virus, so the results will be positive because other viruses will not occur.

While the accuracy of a kit is a validation of comparison of kits made with standard kits determined by the regulator (Dirjenfarmalkes RI). The results of this comparison will provide accuracy figures in percent units.

The results of the preliminary test, explained, the BioCov-19 RT PCR Kit gave the results of 50 copies of the virus (this will be re-validated to determine whether the LoD can still go down even further).

Then, produce 100 percent specificity. This gives the guarantee that this Kit is specific only for COVID-19 detection.

And the accuracy rate is 95 percent, (results are still temporary) comparative test studies are being carried out by reference labs with initial prototypes.

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