Тест-полоски на пищевые аллергены Rapid Test Pro II

A note about the performance measures calculated:

In some cases, there may be minor differences between the numbers on this page and those in the instructions for use. Confidence intervals for sensitivity and specificity that appear on this page were calculated per a score method described in CLSI EP12-A2 (2008).

About this page

Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. In other words, the tests detect the body’s immune response to the infection caused by the virus rather than detecting the virus itself.

In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. This limits the test’s effectiveness for diagnosing COVID-19, and this is one reason serology tests should not be used as the sole basis to diagnose COVID-19.

Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.

However, to use serology tests properly, it is important to understand their performance characteristics and limitations. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as whether the presence of antibodies conveys a level of immunity that would prevent or reduce the severity of re-infection as well as the duration for which immunity lasts.

The performance of these tests is described by their «sensitivity,» or their ability to identify those with antibodies to SARS-CoV-2 (true positive rate), and their «specificity,» or their ability to identify those without antibodies to SARS-CoV-2 (true negative rate).

A test’s sensitivity can be estimated by determining whether or not it is able to detect antibodies in blood samples from patients who have been confirmed to have COVID-19 with a nucleic acid amplification test, or NAAT. In some validation studies of these tests, like the one FDA is conducting in partnership with NIH, CDC, and BARDA, the samples used, in addition to coming from patients confirmed to have COVID-19 by a NAAT, may also be confirmed to have antibodies present using other serology tests.

A test’s specificity can be estimated by testing large numbers of samples collected and frozen before SARS-CoV-2 is known to have circulated to demonstrate that the test does not produce positive results in response to the presence of other causes of a respiratory infection, such as other coronaviruses.

These estimates of sensitivity and specificity are just that: estimates. They include 95% confidence intervals, which are the range of estimates we are about 95% sure a test’s sensitivity and specificity will fall within given how many samples were used in the performance validation.

Tests are also described by their Positive and Negative Predictive values (PPV and NPV). These measures are calculated using a test’s sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called «prevalence» in these calculations).

Every test returns some false positive and false negative results. The PPV and NPV help those who are interpreting these tests understand, given how prevalent individuals with antibodies are in a population, how likely it is that a person who receives a positive result from a test truly does have antibodies to SARS-CoV-2 and how likely it is that a person who receives a negative result from a test truly does not have antibodies to SARS-CoV-2.

The PPV and NPV of a test depend heavily on the prevalence of what that test is intended to detect. Because all tests will return some false positive and some false negative results, including tests that detect antibodies to SARS-CoV-2, broad use of the tests, when not appropriately informed by other relevant information, such as clinical history or diagnostic test results, could identify too many false-positive individuals.

We do not currently know the prevalence of SARS-CoV-2 antibody positive individuals in the U.S. population, and prevalence may change based on the duration the virus is in the country and the effectiveness of mitigations. Moreover, prevalence may vary widely between locations and between different groups of people, such as health care workers, due to different rates of infection.

In low prevalence populations, which will be much of the asymptomatic general population, the result of a single antibody test is not likely to be sufficiently accurate to make an informed decision regarding whether or not an individual has had a prior infection or truly has antibodies to the virus.

Access bio carestart covid-19 igm/igg

Developer: Access Bio, Inc.Test: CareStart COVID-19 IgM/IgGTechnology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance Measure Estimate of Performance95% Confidence Interval
IgMSensitivity (PPA)89.1% (57/64)(79.1%; 94.6%)
IgMSpecificity (NPA)99.5% (181/182)(97.0%; 99.9%)
IgGSensitivity (PPA)96.9% (62/64)(89.3%; 99.1%)
IgGSpecificity (NPA)99.5% (181/182)(97.0%; 99.9%)
CombinedSensitivity (PPA)98.4% (63/64)(91.7%; 99.7%)
CombinedSpecificity (NPA)98.9% (180/182)(96.1%; 99.7%)
CombinedPPV at prevalence = 5%82.5%(55.2%; 94.6%)
CombinedNPV at prevalence = 5%99.9%(99.5%; 100%)

Test Facts:

Acon laboratories acon sars-cov-2 igg/igm rapid test

Developer: ACON Laboratories, Inc.Test: ACON SARS-CoV-2 IgG/IgM Rapid TestTechnology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance Measure Estimate of Performance95% Confidence Interval
IgMSensitivity96.7% (29/30)(83.3%; 99.4%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedPPV at prevalence = 5%58.4%(30.9%; 80.4%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

Test Facts:

Assure tech. assure covid-19 igg/igm rapid test device

Developer: Assure Tech. (Hangzhou Co., Ltd)Test: Assure COVID-19 IgG/IgM Rapid Test DeviceTechnology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance Measure Estimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity90.0% (27/30)(74.4%; 96.5%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%80.8%(40.9%; 96.0%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Babson diagnostics ac19g1

Developer: Babson Diagnostics, IncTest: Babson Diagnostics aC19G1Technology: High Throughput CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)100% (29/29)(88.3%; 100%)
IgGSpecificity (NPA)100% (100/100)(96.3%; 100%)
IgGPPV at prevalence = 5%100%(55.7%; 100%)
IgGNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Beckman coulter access sars-cov-2 igg

Developer: Beckman Coulter, Inc.Test: Access SARS-CoV-2 IgGTechnology: High Throughput CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)96.8% (92/95)(91.1%; 98.9%)
IgGSpecificity (NPA)99.6% (1395/1400)(99.2%; 99.8%)
IgGPPV at prevalence = 5%93.5%(85.2%; 97.2%)
IgGNPV at prevalence = 5%99.8%(99.5%; 99.9%)

Test Facts:

Beckman coulter access sars-cov-2 igm

Developer: Beckman Coulter, Inc.Test: Access SARS-CoV-2 IgMTechnology: High Throughput CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity (PPA)96.7% (146/151)(92.5%; 98.6%)
IgMSpecificity (NPA)99.9% (1398/1400)(99.5%; 100%)
IgMPPV at prevalence = 5%97.3%(90.4%; 99.3%)
IgMNPV at prevalence = 5%99.8%(99.6%; 99.9%)

Test Facts:

Beijing wantai biological pharmacy enterprise wantai sars-cov-2 ab elisa

Developer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.Test: WANTAI SARS-CoV-2 Ab ELISATechnology: ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity96.7% (29/30)(83.3%; 99.4%)
Pan-IgSpecificity97.5% (78/80)(91.3%; 99.3%)
Pan-IgPPV at prevalence = 5%67.1%(33.6%; 88.4%)
Pan-IgNPV at prevalence = 5%99.8%(99.0%; 100%)

Test Facts:

Beijing wantai biological pharmacy enterprise wantai sars-cov-2 ab rapid test

Developer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.Test: WANTAI SARS-CoV-2 Ab Rapid TestTechnology: Lateral FlowTarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity100% (30/30)(88.7%; 100%)
Pan-IgSpecificity98.8% (79/80)(93.3%; 99.8%)
Pan-IgPPV at prevalence = 5%80.8%(40.9%; 96.0%)
Pan-IgNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Biocan diagnostics inc. tell me fast novel coronavirus (covid-19) igg/igm antibody test

Developer: Biocan Diagnostics Inc.Test: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody TestTechnology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity90.0% (27/30)(74.4%; 96.5%)
IgMSpecificity98.7% (78/79)(93.2%; 99.8%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity96.2% (76/79)(89.4%; 98.7%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity96.2% (76/79)(89.4%; 98.7%)
CombinedPPV at prevalence = 5%56.4%(28.1%; 79.9%)
CombinedNPV at prevalence = 5%99.6%(98.8%; 99.9%)

Test Facts:

Biocheck sars-cov-2 igg and igm combo test

Developer: BioCheck, Inc.Test: BioCheck SARS-CoV-2 IgG and IgM Combo TestTechnology: CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity (PPA)95.5% (105/110)(89.8%; 98.0%)
IgMSpecificity (NPA)97.2% (139/143)(93.0%; 98.9%)
IgGSensitivity (PPA)99.1% (109/110)(95.0%; 99.8%)
IgGSpecificity (NPA)100% (143/143)(97.4%; 100%)
CombinedSensitivity (PPA)99.1% (109/110)(95.0%; 99.8%)
CombinedSpecificity (NPA)97.2% (139/143)(93.0%; 98.9%)
CombinedPPV at prevalence = 5%65.1%(41.8%; 82.8%)
CombinedNPV at prevalence = 5%100%(99.7%; 100%)

Test Facts:

Biocheck sars-cov-2 igg antibody test kit

Developer: BioCheck, Inc.Test: BioCheck SARS-CoV-2 IgG Antibody Test KitTechnology: CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)99.1% (109/110)(95.0%; 99.8%)
IgGSpecificity (NPA)100% (143/143)(97.4%; 100%)
IgGPPV at prevalence = 5%100%(65.7%; 100%)
IgGNPV at prevalence = 5%100%(99.7%; 100%)

Test Facts:

Biocheck sars-cov-2 igm antibody test kit

Developer: BioCheck, Inc.Test: BioCheck SARS-CoV-2 IgM Antibody Test KitTechnology: CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity (PPA)95.5% (105/110)(89.8%; 98.0%)
IgMSpecificity (NPA)97.2% (139/143)(93.0%; 98.9%)
IgMPPV at prevalence = 5%64.2%(40.4%; 82.5%)
IgMNPV at prevalence = 5%99.8%(99.4%; 99.9%)

Test Facts:

Biohit healthcare (hefei) biohit sars-cov-2 igm/igg antibody test kit

Developer: Biohit Healthcare (Hefei)Test: Biohit SARS-CoV-2 IgM/IgG Antibody Test KitTechnology: Lateral FlowTarget: Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity96.7% (29/30)(83.3%; 99.4%)
IgMSpecificity95.0% (76/80)(87.8%; 98.0%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedPPV at prevalence = 5%50.4%(26.5%; 72.7%)
CombinedNPV at prevalence = 5%99.8%(99.0%; 100%)

Test Facts:

Biomérieux vidas sars-cov-2 igg

Developer: bioMérieux SATest: VIDAS SARS-CoV-2 IgGTechnology: ELFATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)100% (29/29)(88.3%; 100%)
IgGSpecificity (NPA)99.9% (988/989)(99.4%; 100%)
IgGPPV at prevalence = 5%98.1%(89.1%; 99.7%)
IgGNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Biomérieux vidas sars-cov-2 igm

Developer: bioMérieux SATest: VIDAS SARS-CoV-2 IgMTechnology: ELFATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity (PPA)100% (23/23)(85.7%; 100%)
IgMSpecificity (NPA)99.4% (306/308)(97.7%; 99.8%)
IgMPPV at prevalence = 5%89.0%(65.9%; 96.7%)
IgMNPV at prevalence = 5%100%(99.2%; 100%)

Test Facts:

Bio-rad platelia sars-cov-2 total ab

Developer: Bio-Rad Laboratories, IncTest: Platelia SARS-CoV-2 Total AbTechnology: ELISATarget: Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)98.0% (49/50)(89.5%; 99.6%)
Pan-IgSpecificity (NPA)99.3% (596/600)(98.3%; 99.7%)
Pan-IgPPV at prevalence = 5%88.6%(73.5%; 95.3%)
Pan-IgNPV at prevalence = 5%99.9%(99.4%; 100%)

Test Facts:

Cellex qsars-cov-2 igg/igm rapid test

Developer: Cellex, Inc.Test: qSARS-CoV-2 IgG/IgM Rapid TestTechnology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
CombinedSensitivity (PPA)93.8% (120/128)(88.2%; 96.8%)
CombinedSpecificity (NPA)96.0% (240/250)(92.8%; 97.8%)
CombinedPPV at prevalence = 5%55.2%(39.2%; 70.0%)
CombinedNPV at prevalence = 5%99.7%(99.3%; 99.8%)

Test Facts:

Diasorin liaison sars-cov-2 igm assay

Developer: DiaSorin, Inc.Test: DiaSorin LIAISON SARS-CoV-2 IgM AssayTechnology: CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity (PPA)91.8% (112/122)(85.6%; 95.5%)
IgMSpecificity (NPA)99.3% (2455/2473)(98.9%; 99.5%)
IgMPPV at prevalence = 5%86.9%(79.7%; 91.6%)
IgMNPV at prevalence = 5%99.6%(99.2%; 99.8%)

Test Facts:

Diasorin liaison sars-cov-2 s1/s2 igg

Developer: DiaSorinTest: LIAISON SARS-CoV-2 S1/S2 IgGTechnology: High Throughput CMIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)97.6% (40/41)(87.4%; 99.6%)
IgGSpecificity (NPA)99.3% (1082/1090)(98.6%; 99.6%)
IgGPPV at prevalence = 5%87.5%(76.1%; 93.4%)
IgGNPV at prevalence = 5%99.9%(99.3%; 100%)

Test Facts:

Diazyme laboratories diazyme dz-lite sars-cov-2 igg clia kit

Developer: Diazyme Laboratories, Inc.Test: Diazyme DZ-Lite SARS-CoV-2 IgG CLIA KitTechnology: High Throughput CLIATarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)100% (29/29)(88.3%; 100%)
IgGSpecificity (NPA)97.4% (830/852)(96.1%; 98.3%)
IgGPPV at prevalence = 5%67.1%(54.5%; 75.5%)
IgGNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Diazyme laboratories diazyme dz-lite sars-cov-2 igm clia kit

Developer: Diazyme Laboratories, Inc.Test: Diazyme DZ-Lite SARS-CoV-2 IgM CLIA KitTechnology: CLIATarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)94.4% (102/108)(88.4%; 97.4%)
IgGSpecificity (NPA)98.3% (297/302)(96.2%; 99.3%)
IgGPPV at prevalence = 5%75.0%(54.9%; 87.9%)
IgGNPV at prevalence = 5%99.7%(99.4%; 99.9%)

Test Facts:

Emory medical laboratories sars-cov-2 rbd igg test

Developer: Emory Medical LaboratoriesTest: SARS-CoV-2 RBD IgG testTechnology: ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)100% (30/30)(88.7%; 100%)
IgGSpecificity (NPA)96.4% (615/638)(94.6%; 97.6%)
IgGPPV at prevalence = 5%59.3%(46.6%; 68.6%)
IgGNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Euroimmun sars-cov-2 elisa (igg)

Developer: EUROIMMUNTest: SARS-COV-2 ELISA (IgG)Technology: ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity90.0% (27/30)(74.4%; 96.5%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(46.1%; 100%)
IgGNPV at prevalence = 5%99.5%(98.6%; 99.8%)

Test Facts:

Genalyte maverick sars-cov-2 multi-antigen serology panel v2

Developer: Genalyte, Inc.Test: Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2Technology: Photonic Ring Immunoassay (PRI)Target: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)96.1% (174/181)(92.2%; 98.1%)
Pan-IgSpecificity (NPA)97.7% (842/862)(96.4%; 98.5%)
Pan-IgPPV at prevalence = 5%68.6%(57.7%; 77.4%)
Pan-IgNPV at prevalence = 5%99.8%(99.6%; 99.9%)

Test Facts:

Genscript cpass sars-cov-2 neutralization antibody detection kit

Developer: GenScript USA Inc.Test: cPass SARS-CoV-2 Neutralization Antibody Detection KitTechnology: ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-Ig (Neutralizing)Sensitivity (PPA)100% (26/26)(87.1%; 100%)
Pan-Ig (Neutralizing)Specificity (NPA)100% (88/88)(95.8%; 100%)
Pan-Ig (Neutralizing)PPV at prevalence = 5%100%(52.3%; 100%)
Pan-Ig (Neutralizing)NPV at prevalence = 5%100%(99.3%; 100%)

Test Facts:

Hangzhou biotest biotech rightsign covid-19 igg/igm rapid test cassette

Developer: Hangzhou Biotest BiotechTest: RightSign COVID-19 IgG/IgM Rapid Test CassetteTechnology: Lateral FlowTarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity100% (80/80)(95.4%; 100%)
CombinedPPV at prevalence = 5%100%(50.5%; 100%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Hangzhou laihe biotech lyher novel coronavirus (2021-ncov) igm/igg antibody combo test kit (colloidal gold)

Developer: Hangzhou Laihe BiotechTest: LYHER Novel Coronavirus (2021-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)Technology: Lateral FlowTarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity96.7% (29/30)(83.3%; 99.4%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%80.8%(40.9%; 96.0%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Healgen covid-19 igg/igm rapid test cassette

Developer: HealgenTest: COVID-19 IgG/IgM Rapid Test CassetteTechnology: Lateral FlowTarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedPPV at prevalence = 5%67.8%(35.0%; 88.4%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Inbios scov-2 detect igg elisa

Developer: InBiosTest: SCoV-2 Detect IgG ELISATechnology: ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(50.5%; 100%)
IgGNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Inbios scov-2 detect igm elisa

Developer: InBios International, Inc.Test: SCoV-2 Detect IgM ELISATechnology: ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity96.7% (29/30)(83.3%; 99.4%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgMPPV at prevalence = 5%80.3%(39.4%; 96.0%)
IgMNPV at prevalence = 5%99.8%(99.1%; 100%)

Test Facts:

Innovita (tangshan) biological technology innovita 2021-ncov ab test (colloidal gold)

Developer: Innovita (Tangshan) Biological Technology Co., Ltd.Test: Innovita 2021-nCoV Ab Test (Colloidal Gold)Technology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedPPV at prevalence = 5%67.8%(35.0%; 88.4%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Jiangsu well biotech orawell igm/igg rapid test

Developer: Jiangsu Well BiotechTest: Orawell IgM/IgG Rapid TestTechnology: Lateral FlowTarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.1% (54/58)(83.6%; 97.3%)
IgMSpecificity95.9% (93/97)(89.9%; 98.4%)
IgGSensitivity100% (58/58)(93.8%; 100%)
IgGSpecificity99.0% (96/97)(94.4%; 99.8%)
CombinedSensitivity100% (58/58)(93.8%; 100%)
CombinedSpecificity94.8% (92/97)(88.5%; 97.8%)
CombinedPPV at prevalence = 5%50.5%(30.0%; 70.3%)
CombinedNPV at prevalence = 5%100%(99.6%; 100%)

Test Facts:

Kantaro biosciences covid-seroklir, kantaro semi-quantitative sars-cov-2 igg antibody kit

Developer: Kantaro Biosciences, LLCTest: COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody KitTechnology: Semi-quantitative 2-Step ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)99.1% (233/235)(97.0%; 99.8%)
IgGSpecificity (NPA)99.6% (283/284)(98.0%; 99.9%)
IgGPPV at prevalence = 5%93.7%(72.2%; 98.8%)
IgGNPV at prevalence = 5%100%(99.8%; 100%)

Test Facts:

Luminex xmap sars-cov-2 multi-antigen igg assay

Developer: Luminex CorporationTest: xMAP SARS-CoV-2 Multi-Antigen IgG AssayTechnology: High Throughput FMIATarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)96.3% (79/82)(89.8%; 98.7%)
IgGSpecificity (NPA)99.3% (599/603)(98.3%; 99.7%)
IgGPPV at prevalence = 5%88.4%(73.6%; 95.3%)
IgGNPV at prevalence = 5%99.8%(99.5%; 99.9%)

Test Facts:

Megna health rapid covid-19 igm/igg combo test kit

Developer: Megna Health, Inc.Test: Rapid COVID-19 IgM/IgG Combo Test KitTechnology: Lateral FlowTarget: Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity83.3% (25/30)(66.4%; 92.7%)
IgMSpecificity97.5% (78/80)(91.3%; 99.3%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedPPV at prevalence = 5%51.3%(27.7%; 72.9%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

Test Facts:

Mount sinai hospital clinical laboratory covid-19 elisa antibody test

Developer: Mount Sinai Hospital Clinical LaboratoryTest: Mt. Sinai Laboratory COVID-19 ELISA Antibody TestTechnology: 2-Step ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
CombinedSensitivity (PPA)92.5% (37/40)(80.1%; 97.4%)
CombinedSpecificity (NPA)100% (74/74)(95.1%; 100%)
CombinedPPV at prevalence = 5%100%(46.1%; 100%)
CombinedNPV at prevalence = 5%99.6%(98.9%; 99.9%)

Test Facts:

Nirmidas covid-19 (sars-cov-2) igm/igg antibody detection kit

Developer: Nirmidas Biotech, Inc.Test: Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection KitTechnology: Lateral FlowTarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.1% (54/58)(83.6%; 97.3%)
IgMSpecificity97.9% (95/97)(92.8%; 99.4%)
IgGSensitivity87.9% (51/58)(77.1%; 94.0%)
IgGSpecificity100% (97/97)(96.2%; 100%)
CombinedSensitivity96.6% (56/58)(88.3%; 99.1%)
CombinedSpecificity97.9% (95/97)(92.8%; 99.4%)
CombinedPPV at prevalence = 5%71.1%(39.2%; 90.2%)
CombinedNPV at prevalence = 5%99.8%(99.3%; 99.9%)

Test Facts:

Ortho-clinical diagnostics vitros anti-sars-cov-2 igg test

Developer: Ortho-Clinical Diagnostics, Inc.Test: VITROS Anti-SARS-CoV-2 IgG testTechnology: High Throughput CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)90.0% (36/40)(76.9%; 96.0%)
IgGSpecificity (NPA)100% (407/407)(99.1%; 100%)
IgGPPV at prevalence = 5%100%(81.2%; 100%)
IgGNPV at prevalence = 5%99.5%(98.8%; 99.8%)

Test Facts:

Ortho-clinical diagnostics vitros immunodiagnostic products anti-sars-cov-2 total reagent pack and calibrator

Developer: Ortho-Clinical Diagnostics, Inc.Test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and CalibratorTechnology: High Throughput CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance 95% Confidence Interval
Pan-IgSensitivity (PPA)100% (49/49)(92.7%; 100%)
Pan-IgSpecificity (NPA)100% (400/400)(99.0%; 100%)
Pan-IgPPV at prevalence = 5%100%(83.7.%; 100%)
Pan-IgNPV at prevalence = 5%100%(99.6%; 100%)

Test Facts:

Quansys biosciences q-plex sars-cov-2 human igg (4 plex)

Developer: Quansys Biosciences, Inc.Test: Q-Plex SARS-CoV-2 Human IgG (4 Plex)Technology: CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance 95% Confidence Interval
IgGSensitivity (PPA)95.5% (21/22)(78.2%; 99.2%)
IgGSpecificity (NPA)99.7% (583/585)(98.8%; 99.9%)
IgGPPV at prevalence = 5%93.6%(76.9%; 98.2%)
IgGNPV at prevalence = 5%99.8%(98.9%; 100%)

Test Facts:

Quanterix simoa semi-quantitative sars-cov-2 igg antibody test

Developer: Quanterix CorporationTest: Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody TestTechnology: Semi-quantitative Paramagnetic Microbead-based Sandwich ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance 95% Confidence Interval
IgGSensitivity (PPA)100% (28/28)(87.9%; 100%)
IgGSpecificity (NPA)99.2% (492/496)(97.9%; 99.7%)
IgGPPV at prevalence = 5%86.7%(69.3%; 94.4%)
IgGNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Quotient suisse mosaiq covid-19 antibody magazine

Developer: Quotient Suisse SATest: MosaiQ COVID-19 Antibody MagazineTechnology: Photometric ImmunoassayTarget: Spike

AntibodyPerformance MeasureEstimate of Performance 95% Confidence Interval
Pan-IgSensitivity (PPA)93.0% (80/86)(85.6%; 96.8%)
Pan-IgSpecificity (NPA)99.8% (407/408)(98.6%; 100%)
Pan-IgPPV at prevalence = 5%95.2%(76.6%; 99.2%)
Pan-IgNPV at prevalence = 5%99.6%(99.2%; 99.8%)

Test Facts:

Rapid test kits, diagnostic automation, cortez diagnostics

Diagnostic Automation/Cortez Diagnostics, Inc. is a USA based Company manufacturing and distributing Elisa test kits like :Autoimmune diseases ELISA kit,Blood Bank ELISA kit, Cardiac Markers, Allergy ELISA kits , HIV ELISA KIT, HIV ELISA kits and Rapid tests like : HIV RAPID TEST, Drug tests (Drugs of Abuse Rapid tests), Cardiac rapid tests, Allergy Rapid tests, Cancer Rapid testsPregnancy Rapid tests , Urine Reagent Strips , Etc ; and IFA kits like :Autoimmune diseases IFA kits, Autoimmune Disease kits, Bacterial Disease IFA kits, Etc; and Chemilluminescence immuno assays like :Infectious Disease kits , Fertility Assays (CLIA kits) , Diabetes Assays (CLIA kits) , Cardio-Vascular (CLIA kits) , Tumor Marker Assays kits , Etc ; and Elisa readers — Elisa Washers and Serology test kits.

Roche elecsys anti-sars-cov-2

Developer: RocheTest: Elecsys Anti-SARS-CoV-2Technology: High Throughput ECLIATarget: Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)100% (29/29)(88.3%; 100%)
Pan-IgSpecificity (NPA)99.8% (5262/5272)(99.7%; 99.9%)
Pan-IgPPV at prevalence = 5%96.5%(93.0%; 98.1%)
Pan-IgNPV at prevalence = 5%100%(99.4%; 100%)

Test Facts:

Roche elecsys anti-sars-cov-2 s

Developer: Roche Diagnostics, Inc.Test: Elecsys Anti-SARS-CoV-2 STechnology: Semi-quantitative High Throughput ECLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)96.6% (225/233)(93.4%; 98.3%)
Pan-IgSpecificity (NPA)100% (5990/5991)(99.9%; 100%)
Pan-IgPPV at prevalence = 5%99.7%(98.1%; 99.9%)
Pan-IgNPV at prevalence = 5%99.8%(99.7%; 99.9%)

Test Facts:

Shenzhen new industries biomedical engineering maglumi 2021-ncov igm/igg

Developer: Shenzhen New Industries Biomedical Engineering Co., Ltd.Test: MAGLUMI 2021-nCoV IgM/IgGTechnology: CLIATarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity (PPA)77.5% (110/142)(69.9%; 83.6%)
IgMSpecificity (NPA)99.6% (225/226)(97.5%; 99.9%)
IgGSensitivity (PPA)100% (142/142)(97.4%; 100%)
IgGSpecificity (NPA)99.1% (224/226)(96.8%; 99.8%)
CombinedSensitivity (PPA)100% (142/142)(97.4%; 100%)
CombinedSpecificity (NPA)98.7% (223/226)(96.2%; 99.5%)
CombinedPPV at prevalence = 5%79.9%(57.2%; 92.1%)
CombinedNPV at prevalence = 5%100%(99.9%; 100%)

Test Facts:

Siemens healthcare diagnostics advia centaur sars-cov-2 igg (cov2g)

Developer: Siemens Healthcare DiagnosticsTest: ADVIA Centaur SARS-CoV-2 IgG (COV2G)Technology: Semi-quantitative High Throughput CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)100% (42/42)(91.6%; 100%)
IgGSpecificity (NPA)99.9% (1829/1831)(99.6%; 99.9%)
IgGPPV at prevalence = 5%98.0%(92.4%; 99.4%)
IgGNPV at prevalence = 5%100%(99.6%; 100%)

Test Facts:

Siemens healthcare diagnostics advia centaur sars-cov-2 total (cov2t)

Developer: Siemens Healthcare DiagnosticsTest: ADVIA Centaur SARS-CoV-2 Total (COV2T)Technology: High Throughput CMIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)100% (47/47)(92.4%; 100%)
Pan-IgSpecificity (NPA)99.8% (1586/1589)(99.4%; 99.9%)
Pan-IgPPV at prevalence = 5%96.5%(89.8%; 98.8%)
Pan-IgNPV at prevalence = 5%100%(99.6%; 100%)

Test Facts:

Siemens healthcare diagnostics atellica im sars-cov-2 igg (cov2g)

Developer: Siemens Healthcare DiagnosticsTest: Atellica IM SARS-CoV-2 IgG (COV2G)Technology: Semi-quantitative High Throughput CLIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)100% (42/42)(91.6%; 100%)
IgGSpecificity (NPA)99.9% (1840/1841)(99.7%; 100%)
IgGPPV at prevalence = 5%99.0%(94.0%; 99.8%)
IgGNPV at prevalence = 5%100%(99.6%; 100%)

Test Facts:

Siemens healthcare diagnostics atellica im sars-cov-2 total (cov2t)

Developer: Siemens Healthcare DiagnosticsTest: Atellica IM SARS-CoV-2 Total (COV2T)Technology: High Throughput CMIATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)100% (42/42)(91.6%; 100%)
Pan-IgSpecificity (NPA)99.8% (1089/1091)(99.3%; 99.9%)
Pan-IgPPV at prevalence = 5%96.6%(87.9%; 99.1%)
Pan-IgNPV at prevalence = 5%100%(99.6%; 100%)

Test Facts:

Siemens healthcare diagnostics dimension exl sars-cov-2 total antibody assay (cv2t)

Developer: Siemens Healthcare DiagnosticsTest: Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Technology: High Throughput ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)100% (79/79)(95.4%; 100%)
Pan-IgSpecificity (NPA)99.9% (1527/1529)(99.5%; 100%)
Pan-IgPPV at prevalence = 5%97.6%(91.3%; 99.3%)
Pan-IgNPV at prevalence = 5%100%(99.8%; 100%)

Test Facts:

Siemens healthcare diagnostics dimension vista sars-cov-2 total antibody assay (cov2t)

Developer: Siemens Healthcare DiagnosticsTest: Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)Technology: High Throughput ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)100% (79/79)(95.4%; 100%)
Pan-IgSpecificity (NPA)99.8% (1526/1529)(99.4%; 99.9%)
Pan-IgPPV at prevalence = 5%96.4%(89.7%; 98.7%)
Pan-IgNPV at prevalence = 5%100%(99.8%; 100%)

Test Facts:

Sugentech sgti-flex covid-19 igg

Developer: Sugentech, Inc.Test: SGTi-flex COVID-19 IgGTechnology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(48.9%; 100%)
IgGNPV at prevalence = 5%99.8%(99.1%; 100%)

Test Facts:

Tbg biotechnology tbg sars-cov-2 igg / igm rapid test kit

Developer: TBG Biotechnology Corp.Test: TBG SARS-CoV-2 IgG / IgM Rapid Test KitTechnology: Lateral FlowTarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity95.0% (76/80)(87.8%; 98.0%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedPPV at prevalence = 5%49.6%(25.4%; 72.5%)
CombinedNPV at prevalence = 5%99.6%(98.7%; 99.9%)

Test Facts:

Thermo fisher scientific omnipath covid-19 total antibody elisa test

Developer: Thermo Fisher ScientificTest: OmniPATH COVID-19 Total Antibody ELISA TestTechnology: ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity96.7% (29/30)(83.3%; 99.4%)
Pan-IgSpecificity97.5% (78/80)(91.3%; 99.3%)
Pan-IgPPV at prevalence = 5%67.1%(33.6%; 88.4%)
Pan-IgNPV at prevalence = 5%99.8%(99.0%; 100%)

Test Facts:

University of arizona covid-19 elisa pan-ig antibody test

Developer: University of Arizona Genetics Core for Clinical ServicesTest: COVID-19 ELISA pan-Ig Antibody TestTechnology: 2-Step ELISATarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)97.5% (39/40)(87.1%; 99.6%)
Pan-IgSpecificity (NPA)99.1% (317/320)(97.3%; 99.7%)
Pan-IgPPV at prevalence = 5%84.6%(62.8%; 94.3%)
Pan-IgNPV at prevalence = 5%99.9%(99.3%; 100%)

Test Facts:

Vibrant america clinical labs vibrant covid-19 ab assay

Developer: Vibrant America Clinical LabsTest: Vibrant COVID-19 Ab AssayTechnology: High Throughput CLIATarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
CombinedSensitivity (PPA)98.1% (52/53)(90.1%; 99.7%)
CombinedSpecificity (NPA)98.6% (494/501)(97.1%; 99.3%)
CombinedPPV at prevalence = 5%78.7%(62.4%; 88.6%)
CombinedNPV at prevalence = 5%99.9%(99.5%; 100.0%)

Test Facts:

Wadsworth new york sars-cov microsphere immunoassay for antibody detection

Developer: Wadsworth Center, New York State Department of HealthTest: New York SARS-CoV Microsphere Immunoassay for Antibody DetectionTechnology: MIATarget: Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan-IgSensitivity (PPA)88.0% (95/108)(80.5%; 92.8%)
Pan-IgSpecificity (NPA)98.8% (428/433)(97.3%; 99.5%)
Pan-IgPPV at prevalence = 5%80.0%(61.3%; 90.8%)
Pan-IgNPV at prevalence = 5%99.4%(99.0%; 99.6%)

Test Facts:

Xiamen biotime biotechnology biotime sars-cov-2 igg/igm rapid qualitative test

Developer: Xiamen Biotime Biotechnology Co., Ltd.Test: BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative TestTechnology: Lateral FlowTarget: Spike

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedPPV at prevalence = 5%58.4%(30.9%; 80.4%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

Test Facts:

Zeus scientific zeus elisa sars-cov-2 igg test system

Developer: ZEUS Scientific, Inc.Test: ZEUS ELISA SARS-CoV-2 IgG Test SystemTechnology: ELISATarget: Spike and Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity (PPA)93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity (NPA)100% (70/70)(94.8%; 100%)
IgGPPV at prevalence = 5%100%(44.3%; 100%)
IgGNPV at prevalence = 5%99.7%(98.8%; 99.9%)

Test Facts:

Инструкция по применению: экспресс-тест «realy tech» rapid test (для определения антител igm/igg к коронавирусу covid-19), показания и противопоказания, состав и дозировка — аптекамос

Коронавирус (CoV) принадлежит к роду Nestovirus, Coronaviridae и делится на три типа: альфа, бета и гамма. Типы альфа и бета являются только патогенными для млекопитающих. Род у в основном вызывает заражение птиц. CoV в основном передается путём прямым контактом с выделениями или путём аэрозолем и каплями. Есть также доказательства того, что он может передаваться через фекально-оральный путь.
На сегодня существует 7 типов коронавируса человека (HCoV), которые вызывают респираторные заболевания человека: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV- HKU1, MERS-CoV и новый коронавирусы (2021), они являются важным патогеном респираторных инфекций человека. Среди них новый коронавирус (2021) был обнаружен в 2021 году. Клиническими проявлениями являются системные симптомы, такие как лихорадка и усталость, сопровождающиеся сухим кашлем, одышкой и т. д., которая может быстро развиться в тяжелую пневмонию, дыхательную недостаточность и острое дыхание. Синдром стресса, септический шок, полиорганная недостаточность, тяжелые нарушения кислотно-основного обмена и т.д. даже опасны для жизни.
Когда соответствующее количество тестируемого образца добавляется в отверстие для образца на тестовой карточке, образец движется вперед вдоль тестовой карты под действием капилляра. Если образец содержит антитело IgM, антитело будет связываться с коллоидным меченым золотом нового антигена. Иммунный комплекс захватывается антителом против человеческого IgM, иммобилизованным на мембране, образуя пурпурно-красную линию М, указывающую, что новое антитело IgM к коронавирусу является положительным.
Если образец содержит антитело IgG, антитело будет связываться с меченым коллоидным золотом новым антигеном коронавируса, и иммунный комплекс будет захвачен реагентом, иммобилизованным на мембране с образованием пурпурно-красной линии IgG, что указывает на то, что новое антитело IgG коронавируса является положительным. Если тестовые линии IgG и IgM не окрашены, отображается отрицательный результат. Тестовая карта также содержит строку контроля качества С. Линия контроля качества фуксии С должна появляться независимо оттого, появляется ли тестовая линия. Линия контроля качества является цветной полосой иммунного комплекса контроля качества антитела. Если строка контроля качества С не отображается, результат теста недействителен, и образец необходимо снова протестировать с другой тестовой картой.

Тест-полоски на пищевые аллергены rapid test pro ii

Тест-полоски на пищевые аллергены RapidTestPro

Не только в Японии, но и во всем мире проблемы с аллергией усилились. Пищевые аллергены представляют собой постоянный фактор риска для людей, страдающих от аллергии. Чтобы предотвратить аллергическую реакцию, важно избегать употребления продуктов, вызывающих аллергическую реакцию. Использование надежных тест-наборов или тест-полосок для точного выявления возможного заражения аллергенами стало критической необходимостью для производителей продуктов питания.

Rapid Test Pro Ⅱ — это упрощенный набор тестов для качественного определния пищевых аллергенов, основанный на иммунохроматографическом методе, который подходит для быстрой и простой идентификации загрязнения пищевых аллергенов.

Все серии тест-полосок Rapid Test Pro подходят для:

1) Скрининг-тест сырья

2) Контроль чистоты технологической линии (тест мазка с поверхности, смывные воды с оборудования)

3) Скрининг-тест готовых продуктов (окончательный тест продукта) перед отправкой.

Соответствие законодательству

Поскольку по всему миру существуют положения относительно определенных пищевых аллергенов (например, Положение (ЕС) № 1169/2021; FDA – FALCPA 2004 в США), правильность маркировки продуктов питания имеет чрезвычайную важность. Тест-наборы Elisa и тест-полоски Rapid Test позволяют производителям выполнять все юридические требования и гарантировать безопасность и соответствие их продукции. Следующие ингредиенты были выбраны, как наиболее частые виновники инцидентов: яйцо, молоко, пшеница, гречка, арахис, креветка и краб.

Rapid Test Pro Ⅱ используется для выявления пищевых аллергенов (яйца, молоко, пшеница, гречка и арахис) в пробе на основе метода иммунохроматографии. Когда раствор образца наносится на тест-полоску, в окне теста появляется красно-фиолетовая линия, если в образце содержатся пищевые аллергены (5 ppm и более). Альтернативно, если ни один из пищевых аллергенов не содержится в образце (менее 5 ppm), в окне теста отметка не появится.

Применение тест-полосок RapidTestPro

 Тест-полоски на пищевые аллергены Rapid Test Pro II

Время реакции Rapid Test Pro обычно составляет 15 минут.  Даже с процедурой экстракции измерение может быть выполнено в течение одного часа. Этот простой и быстрый тест сэкономит время на линиях обработки пищевых продуктов, где важна эффективность работы.

Наименование

Кат. #

Тестполоски Rapid Test Pro Ⅱ на яйцо

M2261

Тест-полоски Rapid Test Pro Ⅱ на казеин

M2262

Тест-полоски Rapid Test Pro Ⅱ на глютен

M2263

Тест-полоски Rapid Test Pro Ⅱ на гречиху

M2264

Тест-полоски Rapid Test Pro Ⅱ на арахис

М2265

Тест-полоски Rapid Test Pro Ⅱ на сою

М2266

Экспресс тесты г. санкт-петербург

Быстрые (экспресс) тесты DIAQUICK® *, Австрия. 

Быстрые (экспресс) тесты DIAQUICK® (Rapid Tests) инфекционных заболеваний (HIV, HCV, HBsAg и другие) 

Обязательным элементом оснащения клинических лабораторий на сегодняшний день являются экспресс тесты. Быстрая лабораторная диагностика позволяет выполнять точные анализы в течение очень короткого времени (до 20 минут) после получения биологического материала. 

В ассортимент включены такие номенклатуры, как экспресс тест для определения ВИЧ-инфекции, гепатитов различного типа, сифилиса; быстрые тесты для распознавания хламидий. Тесты на  выявление указанных  инфекций не предназначены для домашнего использования  

№ п/п ТестНаименование и комплектацияКол-во тестов 
1 Гепатит В, AbHbsAB-антитела к гепатиту В, быстрый тест, кассета, 1 тест  1
2 Гепатит В, AgHBsAg-антиген гепатита В, быстрый тест, кассета, фасовка по 30 тестов 1
3 Гепатит С, AbHCV-гепатит С антитела, кассета, 4 мм, быстрый тест, фасовка по 30 тестов 1
4 ВИЧ 1&2 (HIV Ab)HIV-определение ВИЧ антитела 1&2 тип, кассета, быстрый тест; 1 тест, фасовка по 30 тестов 1
5 Сифилис, AbСифилис антитела, быстрый тест, кассета, 1 тест, фасовка по 30 тестов 1
6 ХламидияХламидия, Chlamydia trachomatis, кассеты, быстрый тест на исследование  мазков, тампон для мазка,  20 тестов/упак. 20

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Экспресс-тест для выявления антител igm/igg к вирусу 2021-ncov

Инструкция, PDF

Регистрационное удостоверение, PDF

Набор реагентов «Экспресс-тест кассета 2021-nCoV IgG/IgM»
для качественного иммунохроматографического анализа для выявления антител IgG и IgM к новой коронавирусной инфекции 2021-nCoV
в образце цельной крови, сыворотки или плазмы

номер партии NCP20030295

Cостав комплекта:
1. Тест-кассета — 25 шт.
2. Буфер 3 мл — 1 шт.
3. Пипетка — 25 шт.
4. Инструкция по применению -1 шт.


Производство: Ханчжоу АллТест Биотех Ко., ЛТД (Hangzhou AllTest Biotech Co., LTD.)


Применение экспресс-теста

Тест-полоски на пищевые аллергены Rapid Test Pro II

Интерпретация результата

Тест-полоски на пищевые аллергены Rapid Test Pro II

Показатели эффективности

Эффективность образца IgG
Относительная чувствительность: 100% (ДИ 95%*: 86,0-100%)
Относительная специфичность: 98,0% (ДИ 95%*: 89,4-99,9%)
Точность: 98,6% (ДИ 95%*: 92,3-99,96%)
* Доверительный интервал

Эффективность образца IgM
Относительная чувствительность: 85,0% (ДИ 95%*: 62,1-96,8%)
Относительная специфичность: 96,0% (ДИ 95%*: 86,3-99,5%)
Точность: 92,9% (ДИ 95%*: 84,1-97,6%)
* Доверительный интервал

Диагностическая чувствительность, полученная в ходе проведения клинических испытаний на территории РФ:
— для образцов, взятых через 4–10 дней – 100,0% (95% ДИ: 92,3-100%)
— для образцов, взятых позже 10 дней — 100,0% (95% ДИ: 95,4-100%).

Диагностическая специфичность набора реагентов 100,0% (95% ДИ: 95,2-100%).

Воспроизводимость: межсерийная и внутрисерийная воспроизводимость составляет 100%.

Перекрестная специфичность: Набор реагентов прошел испытания с использованием положительных образцов с содержанием антител к вирусу Гриппу А, антител вирусу гриппа Б, антителк аденовирусу, антител к кори, антител человека к антителам мыши, ревматоидным фактором, неспецифическим IgG, неспецифическим IgM, антител EV71, антител к Парагриппозному вирусу, антител к РСВ, HBsAg, антител к сифилису, антител при H. Pylori, антител при ВИЧ и антител при гепатит С-позитивными образцами. Результаты не показали перекрестной специфичности.

Подробная инструкция, PDF


Запрос на поставку

Nanoentek america frend covid-19 total ab

Developer: NanoEntek America, Inc.Test: FREND COVID-19 total AbTechnology: FIATarget: Nucleocapsid

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
(IgM / IgG)Sensitivity96.7% (29/30)(83.3%; 99.4%)
(IgM / IgG)Specificity98.8% (79/80)(93.3%; 99.8%)
(IgM / IgG)PPV at prevalence = 5%80.3%(39.4%; 96.0%)
(IgM / IgG)NPV at prevalence = 5%99.8%(99.1%; 100%)

Test Facts:

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