From: Tamar Gabunia
Sent: Tuesday, June 16, 2020 5:41 AM
To: Volkan Cetinkaya ; Maddalena Honorati ; Tanvir Hossain ; Nino Ramishvili ; 'Mehek Marwaha' ; Giacomo Ottolini ; 'Benedetta Magnaghi' ; Tamar Tsenteradze ; Iryna Postolovska
Cc: Maia Nikoleishvili ; Beka Jakeli ; Tinatin Khardziani
Subject: RE: Request for NO Objection for purchasing test systems

Best,

Volkan

Dear Volkan,

This is to bring to your attention to the possible stock out of the PCR and Rapid testing kits of nCOVID-19.

Following reopening and resuming economic operation of the country, the higher need of the test consumption is envisaged. Average daily consumption as of May are presented below:

PCR testing - As of June 4, 2020 the number of PCR testing conducted from January 30th is 67,394, out of which 46,011 was utilized in May. Average daily usage is 1,500 testing (the average daily usage including control tests is approximately 1800-2000). Testing will be gradually increased, since the mandatory testing becomes more intensive in risk groups, pre-trial studies are also planned in different regions and the list of groups which are undergoing mandatory testing according to the Order №01-190/o of the Minister dated 7 May will be increased as well. It will initially reach 3,000 daily testing (100,000 tests per month), which may later increase dramatically with the opening of borders and the full development of the economy. Consequently, the country must have at least 100-150,000 test stock at the beginning of each month.

Rapid testing - As of June 4, 2020 the number of Antibody-based testing conducted in the country is 3,521 and the number of antigen-based tests - 411. According to the data of May, the daily usage of Antibody-based tests is 45-55, and antigen-based tests - about 20. An increase of the usage of the rapid tests will depend on the epidemiological situation and amendment to the protocol that is currently focused on utilizing PCR tests. According to the order №01-144/ო of the Minister dated April 1, 2020, the use of antigen-antibody testing is planned in various focus groups, in particular, in pregnant women (routinely), before surgical interventions, in patients with other non-fever somatic diseases, as well as in areas affected by serological studies etc.  Consequently, the usage of the rapid testing is planned to increase to 1000-1500 per day.

Available stock for the testing kits:

PCR        64,896

PCR Extracting kit 54,232

Antibody 29,254

Antigen 34,055

In order to meet the increased demand for testing, it is necessary to fill up the inventory at least for the following two months.  For this purpose, intensive local market survey has been conducted.

PCR - As demand has increased dramatically, there has been a shortage of quality reagents in the world market. Therefore, the selection of supplier was based on a flexible supply scheme taking into account the quality and price of the reagents. An important factor in this process is the existing material and technical resources, platforms of PJR and interactive machines. For some of the testing machines are closed systems, meaning, the reagents can be provided by the manufacturer solely, such as Roche, Abbott, Grifols, Thermo, etc. For acquisition of the reagents of closed testing platforms, we have approached to local dealers of these manufacturers and requested the quotes and delivery schedule. The quotes with the schedule are attached to this email.

As for the open testing systems, a list of tests recommended by WHO was used during the selection, as well as a list of diagnostic kits provided by the Global Fund. Also, in the selection, preference was given to kits already validated and used in Georgia, in particular by the Lugar Center, as the laboratories involved in the diagnostic network nCovid-19 underwent appropriate trainings and were given recommendations (Qiagen, Roboklon, Altona, Sansure, Thermo).

Rapid tests – the approach highlighted above was applied to the local rapid test market as well. In rapid test case, the acquisition of large inventory is not recommended. As situation evolves, so does the quality of the rapid tests. New and improved tests are being registered time after time. Therefore, purchase of more than 50,000 per month is not recommended.

The preference in the selection of rapid test providers was given to the flexible delivery schedule and validated products. In this process, the supplier was identified which already provided the rapid testing kits under COVID-19 project financed by World Bank, which can immediately supply 17,000 units of tests immediately and additional 50,000 units within 2 weeks after the order. These tests have been positively evaluated and validated by the laboratories of Georgia. The results of the laboratory tests and references are attached.

As for the antigen rapid test kits, as you know, there are very few suppliers in the world, out of which fewer are certified and recommended by WHO. In this light, we would like to approach supplier of already validated test kits by the laboratories of Georgia and accredited by WHO. Previously ordered tests by national laboratories were highly satisfactory and recommended. Procurement of 50,000 AG testing kits are planned with the price of US$ 12 per unit (FOB).

In the light above, we kindly request your No Objection to:

1.            Direct contracting for the PCR testing kits as per attached schedule and price;

2.            Amend the contract #COVID19/G/DC-01 for the additional 67,000 units of rapid test kits.

3.            Direct contracting for Antigen Rapid Test Kits from SD Biosensor.

Kind regards,

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister