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PEI – Paul Ehrlich Institut

Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
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Frau Janneke Lupp
janneke.lupp@goodscare.com
Telefon +49 40 3680 7499 12

Herr Thilo Schmitz
thilo.schmitz@goodscare.com
Telefon +49 40 3680 7499 13

Herr Ankama Hango
ankama.hango@goodscare.com
Telefon +49 40 3680 7499 15

Humasis COVID-19 Ag Test

einschrittiger In-vitro-Diagnosetest

Der Humasis COVID-19 Ag Test ist ein einschrittiger In-vitro-Diagnosetest auf der Grundlage eines immunchromatografischen Assays. Er dient zur qualitativen Erkennung von SARS-CoV-2-Antigenen in nasopharyngealen Abstrichproben oder einfachen Nasenmuschel Abstrichen von Patienten, bei denen ein entsprechender Verdacht besteht.

Testprinzip

Der Humasis COVID-19 Ag Test verwendet für COVID-19-Antigene spezifische monoklonale Antikörper zur Erkennung von COVID-19-spezifischen Antigenen in humanen nasopharyngealen Abstrichproben oder mittels einfachen Nasenmuschel Abstrichen. Ein Nitrocellulose-Membranstreifen in der Vorrichtung weist eine Testlinie und eine Kontrolllinie auf. Die Testlinie ist zur Erkennung von SARS-CoV-2-Antigenen mit monoklonalen Anti-Maus-Antikörpern gegen SARS-CoV-2-Nukleocapsid und RBD und die Kontrolllinie ist mit Ziegen-Anti-Maus-IgG beschichtet.

Der Test erkennt zuverlässig auch alle aufgetretenen Virusmutationen.

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Gerne unterstützen wir Sie bei der Umsetzung einer effektiven Teststrategie für Ihr Unternehmen und Ihre Mitarbeiter.

The Igloo Pro from Dx365 sets new standards in point-of-care diagnostics with the simultaneous integration of various advanced lateral flow assay technologies. Using adapters, you can evaluate around 90% of all tests available on the market in one compact analyzer. The display of the test results can be displayed on a PC, smartphone or the integrated display. With its intuitive operation, the Igloo Pro is easy to integrate into existing processes or can quickly and easily expand your diagnostic options, whether stationary or mobile.

Test parameters

Using adapters, around 90% of tests across all manufacturers available on the market can be evaluated in one compact analyzer. In addition to vitamin D, testosterone and cortisol, these include many other markers such as infectious diseases or inflammation values. Also in the veterinary sector.

Data sheet

Methods	colorimetry, immunofluorescence, microfluids, quantum dots, dry chemistry
Samples	serum / plasma / whole blood / capillary blood / saliva / hair sample / urine / stool
Weight	ca. 400g
Measurements	87,5 mm x 87,5 mm x 91 mm (LxWxH)
Measurement duration	few seconds (without incubation time)
Accuracy	CV < 2% - inter-reader, CV < 3% - intra-reader
Date storage	10.000 results
Battery	lithium battery with up to 24 hours of continuous testing per battery charge
Connection	USB-C, LIMS connectivity, WiFi, Bluetooth, connection via API to existing customer software possible

LS2100

Our POC multi-diagnostic device has established itself primarily in medical facilities such as hospitals, private clinics and laboratories and impresses with its ability to process and evaluate up to 8 different test parameters simultaneously. While the result analyses run independently of each other, all 8 results can be shown simultaneously on the display. Optimization of the operating system and an expansion of the test parameters ensure an efficient and wide range of applications in any professional medical environment.

Test parameters

SARS-CoV-2 NAB, D-dimer, long-term blood sugar (HbA1C), thyroid-stimulating hormone (TSH), trijodthyronine (TT3), thyroxine (TT4), ferritin, luteinizing hormone (LH), progesterone, follicle stimulating hormone (FSH), müllerian inhibiting hormone (MIH), prolactin (PRL), ß-human chorionic gonadotropin (ß-HCG), C-reactive protein (CRP), serum amyloid A (SAA), interleukin-6 (IL-6), procalcitonin (PCT), myoglobin (Myo), cardiac troponin (cTnl), creatine-kinase-MB (CK-MB), gastroenetrology enzymes (PG I / PG II), N-terminal pro-B-type natriuretic peptide (NT-proBNP), H-FAB protein, brain natriuretic peptide (BNP)

data sheet

Method	Time-resolved fluorescence immunoassay (TRFIA)
Sample	Serum / plasma / whole blood / capillary blood / saliva / hair sample / urine / stool
Weight	9kg
Dimensions	390mm x 290mm x 205mm (LxBxH)
Screen	10,1" HD Touch Screen
Operating system	Android
Test speed	up to 120 Tests / hour.
Data storage	10.000
Battery	Integrated thermal printer
Communication	RS232(LIS/HIS), RJ45 (LAN), USB

Afinion™ 2 is a fast and compact multi-assay analyzer that provides valuable rapid test results at the point-of-care. The precision-manufactured test cassettes have integrated sampling aids and already contain all the necessary reagents. Regardless of the sample type, precise instant tests can be analyzed from whole blood, plasma or urine. The results can be securely transferred to a hospital or laboratory information system.

Test parameters

Lipid profile (cholesterol), albumin-creatinine-ratio (ACR), long-term blood sugar (HbA1C), C-reactive protein (CRP)

Data sheet

Sample	Capillary blood / urine
Compatibility	Afinion 2 test cartriges
Measurements	328mm x 200mm x 186mm (LxWxH)
Weigth	3,4kg
Display	58x77mm LCD touchscreen
Data storage	500 test results and 500 control results
Communication	USB 2.0 High Speed, Ethernet 10/100 Mbps

LS4000

A versatile point-of-care analyzer of the latest generation. Thanks to its compact and stable design and low power respectively battery consumption, this device offers location-independent and mobile usability. It combines the latest advances in the field of miniaturized components and optical sensors in a portable and cost-effective test device with precise analysis.

Test parameters

Data sheet

Method	Time-resolved fluorescence immunoassay (TRFIA)
Sample	Serum / plasma / whole blood / capillary blood / saliva / hair sample / urine / stool
Weight	600g
Dimensions	191mm x 84,5mm x 45mm (L × W × H)
Screen	5" HD Touchscreen
Operating system	Android
Test speed	15s
Data storage	50.000 tests
Battery	Integrated lithium battery with approx. 24h of standby
Communication	USB-C, WiFi, Bluetooth

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BfArM

PEI – Paul Ehrlich Institut

Anfrage stellen

Ihre Ansprechpartner

Humasis COVID-19 Ag Test

einschrittiger In-vitro-Diagnosetest

Testprinzip

Anfrage Stellen

Gerne unterstützen wir Sie bei der Umsetzung einer effektiven Teststrategie für Ihr Unternehmen und Ihre Mitarbeiter.

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Test parameters

Data sheet

LS2100

Test parameters

data sheet

Test parameters

Data sheet

LS4000

Test parameters

Data sheet