IRIS SARS CoV-2 IgG IgM Rapid Test

Product Name

COVID-19 IgM/IgG test kit (Colloidal Gold)

Specifications

25 tests/box

We are the exclusive distributor in the USA and Brazil

Under FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency have permission to distribute in the USA 

Intended Use

This kit is used for the qualitative determination of COVID-19 IgM/IgG antibodies in human serum, plasma and venous whole blood samples in vitro, as an auxiliary diagnosis of COVID-19 infection for hospitals and home use.

€675.00
Out of stock

If you are representing Government, Public Institution, Doctors Associations and want to order more tests please write us an email at [email protected]

Introduction & detection principle

Steps
1. Place a Test Device on a clean and level surface
2. Add 10 μL whole blood (fingertip/venous), serum or plasma onto the specimen well of a Test Device. 
3. Add 2 drops (about 60-80 μL) of buffer onto the specimen well of a Test Device.
4. Read the test result at 15 minutes. Don’t read the result after 20 minutes.

The IRIS SARS CoV-2 IgG IgM is a colloidal gold-based immunochromatographic strip assay produced by Alpha Pharma Industry (Bari, Italy). The test is rapid (10-14 min) and is based on a lateral flow immunoassay targeted to evaluate the presence or absence of anti-SARS-CoV-2-IgM and anti-SARS-CoV-2-IgG. The test is validated for different human specimens: capillary blood, venous whole blood, serum and/or plasma.

 

The IRIS SARS CoV-2 IgG IgM utilizes Anti-human IgG and anti IgM against the Receptor-Binding Domain of the COVID-19 spike protein recombinant antigen. The strip test consists by a nitrocellulose membrane incorporating mouse anti-human-IgM and IgG monoclonal antibody, plus anti-rabbit-IgG immobilized in different position (M and G lines) and in control line (C line), respectively.

 

The use of the test is extremely simple and rapid: the sample (10-15 ul) is deposited in sample-port and few second later 2 drops are added (the buffer is supplied together with the test in a dropper bottle). The blood macromolecules are moved forward by capillarity and "walk" along the nitrocellulose strip which has been absorbed by a mixture of recombinant antigen AuNP-COVID-19 and AuNP-rabbit-IgG. If anti-SARS CoV-2 IgM antibodies are present in the patient's blood, they bind to the viral antigen labelled with colloidal gold, then forming a sandwich with the anti-human IgM monoclonal antibody (present only on one line marked by the letter M); in this case the line will turn pink-red. Similarly, for IgG, in a second line in which monoclonal antibodies to human IgG are present.

 

If both lines are not dyeing, the test will be considered as negative; vice versa the development of a coloured band (even if not very intense) on the IgG and/or IgM line indicates the presence of anticovid antibody in the patient blood and the test will be considered positive. The device also contains a quality control line C, which must always colour and check that the kit is working properly.

Components

Do not mix use the Components from different lot number

2.0 Experimental data results

2.1.1 Preliminary test on sensitivity and specificity

Test are performed in the clinical setting of Catanzaro Lido Polyclinic (Dr Maurizio Cipolla, MD, Pathologist) in cooperation with the Catanzaro Hospital (Dept of Infectious Diseases) for the RT-PCR execution according with the Italian Government Guide Lines.

Sample size 15 adults of both sexes, aged 30-70 yr., with suspected diagnosis of Covid19 infection.

Operating Procedures: IRIS SARS CoV-2 IgG IgM test execution in the same day of pharyngeal swab for RT-PCR detection of Covid-19 according with WHO guideline and procedure advised by Regione Calabria and Italian Health Ministry. IRIS SARS CoV-2 IgG IgM test samples: capillary blood


Statistics: non parametric test (Cohen’s K and exact McNemat test). Probability of Agreement, Concordance, and Cohen’s K categorization according to DG Altman and R. Kwiecien1

The Results for IgG test: Cohen's k = 1.000; exact McNemar test: p > 0.999. Sensitivity 100,0% (95% Intervals of Confidence= 39.7-100.0). Specificity 100,0% (95%IC= 71,5-100.0).

Results for IgM test Cohen's k = 0.842; exact McNemar test: p > 0.99. Sensitivity 100,0% (95% Intervals of Confidence= 39.7-100.0). Specificity 90,1% (95%IC= 58.7-99.7).

2.1.2 Final test on sensitivity and specificity

The tests were performed as previously described (see 2.1.1). The overall sample (pooled data) consists of 161 adult subjects of both sexes

IgM results: Cohen's k = 0.963, McNemar exact test: p > 0.9999.

IgG results: Cohen's k = 0.963, McNemar exact test: p = 0.2500

2.2.1 Clinical protocol (in- and out-patients)

Test are performed in the clinical setting of San Camillo Forlanini Hospital in Rome (Dr Gabriella Parisi) (Dept of Microbiology and Virology). The PCR test are performed according with Italian Istituto Superiore di Sanità (ISS) and Italian Health Ministry guideline and recommendations

Sample size 365 patients selected on the basis of the symptoms or candidate to surgery, from the Emergency, Surgery and Internal Medicine Departments. Patients of both sexes (no age-based exclusion criteria) with suspected diagnosis of Covid19 infection or candidate to the PCR before admission to surgery.

Operating Procedures: IRIS SARS CoV-2 IgG IgM test execution within 36-48 hrs before or after pharyngeal swab for RT-PCR detection of Covid-19 according with WHO guideline and procedure advised by ISS and Italian Health Ministry. IRIS SARS CoV-2 IgG IgM test samples: venous whole blood or plasma after REB separation by centrifugation.

 

Results:

 

On 365 patients, 353 showed the same results both with PCR and IRIS SARS CoV-2 test. The concordance rate resulted of 97%. In 12 patients with discordant results, 7 resulted negative to the RT-PCR and positive for IgM only (n=6), for IgM and IgG (n=1<) while the RT-PCR resulted negative (see footnote 1, previous page). After a second oropharyngeal swab for RT-PCR second control performed on discordant patients, 5 patients tested positive to RT-PCR, thus the used test gave a

 

98.1% (358/365) concordance (e.g., accuracy), with an expected CI95% from 96.1% to 99.2%

 

2.2.2 Healthcare personnel survey

 

Test are performed on the Doctors and Nurses of the San Camillo Forlanini Hospital in Rome (Dr Gabriella Parisi, Dept of Microbiology and Virology). The PCR test are performed as previously described.

 

Sample size 180 doctors and nurses selected among the San Camillo-Forlanini Hospital healthcare personnel (adults, both sexes) on the basis of risk exposition to Covid-19 infection.

 

Operating Procedures: IRIS SARS CoV-2 IgG IgM test execution together with the pharyngeal swab for RT-PCR detection of Covid-19, according with WHO guideline and procedure advised by ISS and Italian Health Ministry. IRIS SARS CoV-2 IgG IgM test samples: venous whole blood or plasma and/or capillary blood.

Results: concordant results were documented in 176/180 hospital employees, the accuracy was 97.8% (176/180), with an expected CI95% from 94.4% to 99.4%.Discordant results (n=4): 1 false negative results -for both IgM and IgG rapid test- with positive oropharyngeal swab; 2 false negative of RT-PCR; one was classified as "doubtful IgM positivity" (due to the difficulty of reading the IgM band): this patient had a positive PCR test and certainly negative IgG band and should be included among the possible false negatives of the rapid test.

*** * ***

The test carried on the whole San Camillo sample (patients plus health workers) gave a 97.8% accuracy, with an expected CI95% ranging from 96.2% to 98.9%.

2.3 IRIS SARS CoV2 test in the setting of the occupational medicine and industry worker protection

Tests were carried out on the employees of a company (Sorical SPA, General manager Pia Chiarella) working in the field of drinking water and water supplies of almost all the Calabrian municipalities. The aim is checking all employees of the industry (continuous monitoring of Covid-19 infection by rapid test and quarantine any COVID-19 positive employee).

 

Operating Procedures: all employees were invited to take the IRIS SARS CoV-2 IgG IgM rapid test during working hours, inside the factory. The test was repeated every 15 days. Employees were also given a computerized Covid card (with information on their health, co-morbidity and any symptoms present) and the data were sent to the competent doctor. The RC-PCR test was performed only if the rapid test was positive.

Sample size: 172 healthy employees (aged 20-70, males and females) were tested. At present two controls were performed (total 344 IRIS SARS CoV-2 tests).

Results: only 1 case resulted positive to the IgM test (IgG negative, first RT-PCR test negative): the employee was released from the work (quarantine) waiting the second RT-PCR test in accordance with the Italian legal provisions and with the guidelines. No new cases of seroconversion were detected during the first phase of the follow up.

3.0 Conclusions

The IRIS SARS-CoV-2 IgG / IgM rapid test has a very high sensitivity and specificity; has been successfully used in different settings, for monitoring and diagnosing patients (belonging to General Medicine, Emergency Dept or Internal Medicine) and for the periodic survey of industrial and healthcare personnel.

 

We consider this test valid and reliable in several sectors (food industry, hospitals and medical centres, other strategic industries) both for the high sensitivity and specificity (and therefore accuracy) and for the extreme ease of use and reading. In fact, over 900 tests carried out during the study and validation phase in Italy, no cases of difficulty / impossibility of execution were reported, even in non-specialist environments; in only one case was a doubt reported on reading the coloured band.

 

In our opinion, a test with such high sensitivity and specificity is also indicated for epidemiological purposes on large sections of the population (general population and/or high-risk groups). From a clinical point of view, it is indicated for the diagnosis of Covid19 infection and / or the differential diagnosis with respect to other diseases, according to good clinical practices, which require the doctor to consider all the diagnostic elements (clinic, instrumental, laboratory, included the RT-PCR). Furthermore, the use of the IRIS SARS CoV-2 test can reveal patients with false negative RT-PCR, as suggested by the WHO guidelines and the literature. It should be noted that the execution of the rapid serological test, while not replacing the use of swabs to identify viral RNA, is not operator-dependent and therefore very suitable for the setting of primary care2.

 

Coordinators of the Scientific Committee

Maurizio Cipolla MD, Pathologist

 

President of Digital Sit Calabria (Italian Society of Digital Health and Telemedicine Scientific director of the multicronicity plans Regione Calabria (Italy) Scientific director of Digitcal Srl

 

Prof. Antonio Vittorino Gaddi, MD, PhD

 

Research Doctor in Experimental Medicine and Atherosclerosis - Consultant: Cardiology, Geriatrics and Gerontology

 

Main Investigator of Health Research and Development SrL, IT -Scientific Director of Qi International Ltd, London, UK

 

Past President of the Medicine and Surgery undergraduate course of the Bologna University - Past Director, of Giancarlo Descovich Bologna Center of Atherosclerosis and Metabolic Diseases President of Digital SIT-EMR (Italian Society of Digital Health and Telemedicine, Emilia Romagna Region), Director of Scientific Board of EuroGenLab (BO) and Health-Lab, GT Foundation (MO).

 

Lugo Medica and Caravelli Lab & EuroGenLab, via Acquacalda 3 (Lugo, RA) and via Zamboni 8, Bologna,051 231531 -mobile+39 3341953354 https://www.researchgate.net/profile/Antonio_Gaddi- https://it.wikipedia.org/wiki/Antonio_Vittorino_Gaddi

Info about FDA and distribution right

The attached acknowledgment letter from FDA shows that an EUA request was submitted to the FDA for the Alpha Pharma Service srl, IRIS SARS-CoV-2 IgG/IgM Rapid Test.  The EUA request is under review. Currently, the IRIS SARS-CoV-2 IgG/IgM Rapid Test is not an EUA authorized test but FDA does not intend to object to its distribution per the Policy for Coronavirus Disease-2019 Tests because it appears on the aforementioned list.

 

FDA maintains two lists on FDA’s webpage for FAQs on Testing for SARS-CoV-2, identifying commercial manufacturers that intend to distribute tests pursuant to FDA's Policy for Coronavirus Disease-2019 Tests:

  1. Commercial Manufacturers that have notified the FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of FDA's Policy for Coronavirus Disease-2019 Tests.
  2. Manufacturers that have notified FDA that they have validated and intend to distribute serology tests as set forth in Section IV.D of FDA's Policy for Coronavirus Disease-2019 Tests.

 

Under FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website.

 

As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use:

  • This test has not been reviewed by the FDA.
  • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

 

Please accept this email as notification that the Alpha Pharma Service srl, IRIS SARS-CoV-2 IgG/IgM Rapid Test may be distributed while an EUA is pending.

Check the file here

Certificates

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If you are representing Government , Public Institution , Doctors Associations or any other Group of people and want to order more tests please write us an email with the exact number of tests you would like and we will try to do our best to provide you as fast as possible.

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