Covid-19 Coronavirus

Available tests for Coronavirus SARS-CoV-2 infection are:

1. The Search of viral RNA in Nasopharyngal Swabs

What it looks for (target): the test looks for the RNA of the Coronavirus SARS-CoV-2 in oral-nasopharyngeal swabs or in a respiratory tract sample according to WHO indications. The test directly detects the presence of the virus; infected people may be asymptomatic at the present and have never had symptoms. This test reveals if the patient is contagious.

Who is it for: to everyone may need to diagnose a Coronavirus SARS-CoV-2 infection, doctor's prescription is not requested.

Sample type: upper respiratory tract sample, the best is a nasopharyngeal swab.

Preparation: during the two hours prior to the swab collection, the patient must not have eaten, smoked, drank liquids other than water, brushed his teeth or used mouthwashes or similar.

Method of analysis: Automated extraction by Eu-Pathogen Kit, Eurospital, CE / IVD, 200uL of sample, elution in 100 uL, Real time PCR: automatic preparation of the PCR reaction by QIAgility, Qiagen; Real time PCR amplification on CFX96, Biorad by NeoPlex™ COVID-19 FAST ( RdRp - N genes; IC beta globin; detection limit 8,5 copies / uL), Genematrix, CE / IVD / FDA approved.

THIS DIAGNOSTIC KITS  DETECT ALL VARIATIONS OF Coronavirus SARS-COV-2.

Report: The report is in Italian and English, it is sent by e-mail within 24 hours from sample collection unless retest/invalid sample.

Results (are all automatically communicated to the Regional Health Department):

DETECTED                                             Positive Result (the Regional Health Department will contact the patient)

NOT DETECTED                                     Negative Result

DETECTED WITH LOW VIRAL LOAD    Doubtful Result (the Regional Health Department will contact the patient)

INVALID                                                    Sample can not be analyzed, new sample must be collected

N.B. ALL RESULTS ARE COMMUNICATED TO THE TUSCANY REGION HEALTH DEPARTMENT, PUBLIC HYGIENE SERVICE, THAT WILL CONTACT THE PATIENT IN CASE OF POSITIVITY OR POSITIVITY AT LOW VIRAL LOAD, informing about the behaviors to be adopted, tests to be done, the quarantine times, etc. (all  these informations can not be given by the Laboratory that is authorized only to perform the test and charge the results on SISPC web site).

Covid reports on the Electronic Health Record

As part of preventing measures and of the management of the epidemiological COVID19 emergency, the reports of molecular swabs antigenic and serological tests for the diagnosis of infection with the SARS-CoV-2 virus performed at LAMM are available on your Electronic Health Record available on the Tuscany Region website.


2. The Search of viral RNA in Saliva

What it looks for (target): the test looks for the RNA of the Coronavirus SARS-CoV-2 in saliva samples. The test directly detects the presence of the virus; infected people may be asymptomatic at the present and have never had symptoms. This test reveals if the patient is contagious.

Who is it for: saliva test can be requested by asymptomatic patients who must be tested frequently for screening programs requested at work, in particular very old people, people with disabilities and children.

Sample type: saliva.

Preparation: during the two hours prior to the swab collection, the patient must not have eaten, smoked, drank liquids other than water, brushed
his teeth or used mouthwashes or similar.

Method of analysis: Automated extraction by Eu-Pathogen Kit, Eurospital, CE / IVD, 200uL of sample, elution in 100 uL, Real time PCR: automatic preparation of the PCR reaction by QIAgility, Qiagen; Real time PCR amplification on CFX96, Biorad by NeoPlexTM COVID-19 FAST (RdRp - N genes; IC beta globin; detection limit 8,5 copies / uL), Genematrix, CE / IVD / FDA approved.

THIS DIAGNOSTIC KITS DETECT ALL VARIATIONS OF Coronavirus SARS-COV-2.

Report: The report is in Italian and English, it is sent by e-mail within 24 hours from sample collection unless retest/invalid sample.

Results (are all automatically communicated to the Regional Health Department):
DETECTED                                                 Positive Result (the Regional Health Department will contact the patient)
NOT DETECTED                                        Negative Result
DETECTED WITH LOW VIRAL LOAD       Doubtful Result (the Regional Health Department will contact the patient)
INVALID SAMPLE                                      Can not be analyzed, new sample must be collected

N.B. ALL RESULTS ARE COMMUNICATED TO THE TUSCANY REGION HEALTH DEPARTMENT, PUBLIC HYGIENE SERVICE, THAT WILL CONTACT THE PATIENT IN CASE OF POSITIVITY OR POSITIVITY AT LOW VIRAL LOAD, informing about the behaviors to be adopted, tests to be done, the quarantine times, etc. (all these informations can not be given by the Laboratory that is authorized only to perform the test and charge the results on SISPC web site).

Covid reports on the Electronic Health Record

As part of preventing measures and of the management of the epidemiological COVID19 emergency, the reports of molecular swabs antigenic and serological tests for the diagnosis of infection with the SARS-CoV-2 virus performed at LAMM are available on your Electronic Health Record available on the Tuscany Region website.


3. Antigenic test for Coronavirus SARS-CoV-2

What it looks for (target): the antigenic test detects a Coronavirus SARS-CoV-2 protein Nucleocapsid protein (N) in oral-nasopharyngeal swabs.

Who is it for: to those who request it, you do not need a doctor's prescription

Sample type: upper respiratory tract sample, the best is a nasopharyngeal swab

Preparation: during the two hours prior to the swab collection, the patient must not have eaten, smoked, drank liquids other than water, brushed his teeth or used mouthwashes or similar.

Method of analysis: Lumipulse G SARS-CoV-2 Ag antigen test for the detection and quantitative measurement of SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swabs. The test, with CE / IVD certified, uses CLEIA technology (chemiluminescent immunoassay). This method is authorized by the Tuscany Region (DGRT 61/2021) and  it is the only one that does not require confirmation with Molecular Swab if the test is positive. Any confirmation remains mandatory on the same sample in the case of a doubtful outcome.

Report: The report is delivered in Italian and English to the e-mail provided within 4 hours unless double-checked/invalid sample.

Results (are all automatically communicated to the Regional Health Department):

REACTIVE                     Positive Result (the Regional Health Department will contact the patient)

NON REACTIVE            Negative Result

DOUBTFUL RESULT     Sample needs to be analyzed by molecular test

INVALID                         Sample can not be analyzed, new sample must be collected

In case of doubtfull result , according to DRT, the sample must be analyzed by Molecular PCR test which can be performed on the same sample, with a result available within 24 hours.

N.B. ALL RESULTS ARE COMMUNICATED TO THE TUSCANY REGION HEALTH DEPARTMENT, PUBLIC HYGIENE SERVICE, THAT WILL CONTACT THE PATIENT IN CASE OF POSITIVITY OR POSITIVITY AT LOW VIRAL LOAD, informing about the behaviors to be adopted, tests to be done, the quarantine times, etc. (all  these informations can not be given by the Laboratory that is authorized only to perform the test and charge the results on SISPC web site).


4. Quantitative Serological Test

What it looks for (target): the serological test performed at LAMM is a CLIA (Chemiluminescense Immunassay) test, authorized by the Ministry of Health; the following CE/IVD marked diagnostic kits are used.

- IgM assay (anti-N, Nucleocapsid protein and anti-S, Spike surface protein) with quantitative result: MAGLUMI® 2019-nCoV IgM (CLIA) manufacturer SNIBE distributor Medical Systems;

- at LAMM is now available the new second generation test that detects and measures the IgG antibodies produced against a specific region (RBD epitope) of the surface protein (Spike) of the Coronavirus SARS-CoV-2: MAGLUMI® SARS-CoV-2 S-RDB IgG (CLIA) manufacturer SNIBE distributor Medical Systems.

Who is it for: to those who request it, doctor's prescription is not required. The test is suggested to verify if a patient had a contact with the virus, or to verify if the vaccine has induced an immune response. It is not the gold standard test to diagnose Coronavirus SARS-CoV-2 infection. The gold standard test to diagnose a Coronavirus SARS-CoV-2 infection according to WHO and Ministry of Health is the molecular test on nasopharyngeal swab.

It is also possible to search separately for IgM or IgG at a cost of € 25.00 each.

Sample type: serum-plasma EDTA

Preparation: none

Analysis method: CLIA (Chemiluminescense Immunassay)

Report: available in italian and english by e-mail within 12 hours from sample collection except for retest or invalid samples.

Results:

< 1 UA/ml   NEGATIVE RESULT

> 1 UA/ml   POSITIVE RESULT (THE TUSCANY REGIONAL HEALTH SYSTEM WILL CONTACT THE PATIENT: THE SANITARY PROTOCOL NEED A MOLECULAR TEST THAT CAN BE BOOK BY CALLING THE GREEN NUMBER 800556060  (FOR FREE) OR AT LAMM SRL COST 50 EUROS AND NOT 70 EUROS.

N.B. ALL RESULTS ARE COMMUNICATED TO THE TUSCANY REGION HEALTH DEPARTMENT, PUBLIC HYGIENE SERVICE, THAT WILL CONTACT THE PATIENT IN CASE OF POSITIVITY OR POSITIVITY AT LOW VIRAL LOAD, informing about the behaviors to be adopted, tests to be done, the quarantine times, etc. (all  these informations can not be given by the Laboratory that is authorized only to perform the test and charge the results on SISPC web site).

Covid reports on the Electronic Health Record

As part of preventing measures and of the management of the epidemiological COVID19 emergency, the reports of molecular swabs antigenic and serological tests for the diagnosis of infection with the SARS-CoV-2 virus performed at LAMM are available on your Electronic Health Record available on the Tuscany Region website.


MORE INFORMATION ON COSTS, REPORTING TIMES, BOOKING

> Swab

> Serological

> Rapid Antigen Test


CERTIFICATIONS CENTRO ANALISI LAMM

SARS-CoV-2 MOLECULAR DIAGNOSIS CERTIFICATION issued by AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA, Department of Laboratory Medicine U.O. Complex Virology

INTERNAL MOLECULAR QUALITY CONTROL FOR COVID-19 (ENG)

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