SARS-CoV-2 Testing Services

The Tentamus Japan laboratory is certified for sampling, preparation, testing and reporting for coronavirus in human saliva. The sample is taken directly into a sample vial before transport to the laboratories for testing.

Results can be delivered typically within 24 hours.

The test samples are measured by the accurate PCR (polymerase chain reaction) method recognised by international health agencies.

We provide you with suitable swabs with which you can take samples of:

• Sales counters, door handles, light switches, work objects, keyboards, shopping trolleys, etc.
• Toys, toothbrushes, packaging materials, etc.
• Respiratory masks, protective clothing, etc.
• Used or reprocessed protective masks

These samples are then analyzed for SARS-CoV-2 in our laboratories for you. Within 3 days after receipt of the samples, you will receive the results from us!

According to the ISO EN 14683:2019+AC:2019, surgical masks and medical face masks, in general, should fulfill defined safety standards before being placed on the European market.

To fulfill these criteria Tentamus offers the following testing strategies in compliance with ISO 14683:

• Bacterial filtration efficiency (BFE)
• Breathability
• Splash Resistance
• Biocompatibility
• Microbiological Safety
• Bioburden
• Product Specific Pyrogenicity

The biological safety of medical devices is essential not only during the times of the Corona pandemic. Tentamus offers a sophisticated and accredited platform for biological safety testing of medical devices within the framework of the DIN ISO 10993 comprising the following test platforms:

• Chemical charaaterization of Medical Devices (ISO 10993-18)
• Determination of cytotoxicity in vitro (ISO 10993-5)
• Determination of Bioburden (ISO 11737-1/2)
• Determination of Bacterial Endotoxin – LAL (Ph. Eur. 2.6.14)
• Determination of Pyrogens – MAT (Ph. Eur. 2.6.30)
• Determination of Skin Irritation (OECD TG 439 / ISO 10993-23 as draft)
• Determination of Skin Sensitization (OECD TG 442d/e
• Determination of Hemocompatibility (ISO 10993-4)
• Determination of Genotoxicity (ISO 10993-3)

Regulatory compliance, physio-chemical analysis as well as the efficacy testing of bactericidal, fungicidal, virucidal properties of disinfectants, and hand sanitizers are essential for manufacturers and healthcare providers.

For authorization purposes regarding bringing hand sanitizer and surface disinfectants to the market, Renolab holds a Good Laboratory Practice (GLP) certificate, and is certified by the Italian Ministry of Health to provide the following services:

• Complete qualitative and quantitative composition of formulae
• Stability test in compliance with CIPAC methodologies (i.e. CIPAC MT 46.3)

In order to secure the supply of critical drugs in Germany and Europe, the pharmaceutical laboratories of the Tentamus Group support pharmaceutical companies with:

• Analytical method transfers
• In-process controls
• Cleaning validations
• Quality controls
• Stability studies
• Release analytics
• Batch certification via a separate qualified person (QP)

Tentamus Watcher a web tool capable of combining the results of the analysis of the coronavirus (SARS-CoV-2) in wastewater together with indicators of health evolution.

The software generates graphics and visual information about the evolution of the coronavirus in cities and municipalities. It also provides alerts of possible outbreaks. Therefore, the tool allows public authorities to anticipate and improve the decision making.

The detection of mild or asymptomatic cases through wastewater testing has become a fundamental epidemiological tool for early warning of the presence of SARS-CoV-2, both at the present time and in possible outbreaks or second waves of infection.