Desempenho de teste de sorologia autorizado EUA

Sobre esta página

Os testes sorológicos detectam a presença de anticorpos no sangue quando o corpo está respondendo a uma infecção específica, como o COVID-19. Em outras palavras, os testes detectam a resposta imune do corpo à infecção causada pelo vírus, em vez de detectar o próprio vírus.

Nos primeiros dias de uma infecção quando a resposta imune do corpo ainda está em formação, os anticorpos podem não ser detectados. Isso limita a eficácia do teste para diagnosticar o COVID-19, e esse é um dos motivos pelos quais os testes sorológicos não devem ser usados ​​como única base para o diagnóstico do COVID-19.

Os testes sorológicos podem desempenhar um papel na luta contra o COVID-19, ajudando os profissionais de saúde a identificar indivíduos que podem ter desenvolvido uma resposta imune ao SARS-CoV-2. Além disso, esses resultados do teste podem ajudar a determinar quem pode doar uma parte do sangue chamada plasma convalescente, que pode servir como um possível tratamento para aqueles que estão gravemente doentes com o COVID-19.

No entanto, para usar os testes sorológicos corretamente, é importante entender suas características e limitações de desempenho. Além disso, estão sendo realizados estudos para abordar questões que melhor informarão o uso apropriado desses testes, como se a presença de anticorpos transmite um nível de imunidade que impediria ou reduziria a gravidade da reinfecção, bem como a duração da imunidade dura.

O desempenho desses testes é descrito por sua “sensibilidade” ou sua capacidade de identificar aqueles com anticorpos para SARS-CoV-2 (taxa positiva verdadeira) e sua “especificidade” ou sua capacidade de identificar aqueles sem anticorpos para SARS- CoV-2 (taxa negativa verdadeira). A sensibilidade de um teste pode ser estimada determinando se ele é capaz de detectar anticorpos em amostras de sangue de pacientes que foram confirmados como tendo COVID-19 com um teste de amplificação de ácido nucleico ou NAAT.

Em alguns estudos de validação desses testes, como o que o FDA está realizando em parceria com o NIH, CDC e BARDA, as amostras utilizadas, além de provenientes de pacientes que confirmam ter COVID-19 por um NAAT, também podem confirmar anticorpos presentes usando outros testes sorológicos. A especificidade de um teste pode ser estimada testando-se um grande número de amostras coletadas e congeladas antes que se saiba que o SARS-CoV-2 circulou para demonstrar que o teste não produz resultados positivos em resposta à presença de outras causas de uma infecção respiratória, como como outros coronavírus.

Essas estimativas de sensibilidade e especificidade são exatamente isso: estimativas. Eles incluem intervalos de confiança de 95%, que são o intervalo de estimativas em que temos cerca de 95% de certeza de que a sensibilidade e a especificidade de um teste se enquadrarão, considerando quantas amostras foram usadas na validação de desempenho. Quanto mais amostras forem usadas para validar um teste, menor será o intervalo de confiança, o que significa que podemos ter mais confiança nas estimativas de sensibilidade e especificidade fornecidas.

Os testes também são descritos por seus valores preditivos positivo e negativo (VPP e VPN). Essas medidas são calculadas usando a sensibilidade de um teste, sua especificidade e usando uma suposição sobre a porcentagem de indivíduos na população que possuem anticorpos para SARS-CoV-2 (que é chamada de “prevalência” nesses cálculos). Todo teste retorna alguns resultados falso positivos e falsos negativos. O PPV e o NPV ajudam aqueles que estão interpretando esses testes a entender, considerando a prevalência de indivíduos com anticorpos em uma população, qual a probabilidade de uma pessoa que receber um resultado positivo de um teste realmente ter anticorpos para SARS-CoV-2 e qual a probabilidade de uma pessoa que receber um resultado negativo de um teste realmente não possuir anticorpos para SARS-CoV-2. O PPV e o NPV de um teste dependem muito da prevalência do que esse teste se destina a detectar. Como todos os testes retornam resultados falso-positivos e falsos negativos, incluindo testes que detectam anticorpos para SARS-CoV-2, amplo uso dos testes, quando não são adequadamente informados por outras informações relevantes, como histórico clínico ou resultados de testes de diagnóstico, poderia identificar muitos indivíduos falso-positivos.

Atualmente, não sabemos a prevalência de indivíduos positivos para anticorpos SARS-CoV-2 na população dos EUA, e a prevalência pode mudar com base na duração do vírus no país e na eficácia das mitigações. Além disso, a prevalência pode variar amplamente entre locais e entre diferentes grupos de pessoas, como profissionais de saúde, devido a diferentes taxas de infecção. Em populações de baixa prevalência, que serão grande parte da população em geral assintomática, o resultado de um único teste de anticorpo provavelmente não será suficientemente preciso para tomar uma decisão informada sobre se um indivíduo teve ou não uma infecção anterior ou realmente possui anticorpos para o vírus. Um segundo teste, normalmente aquele que avalia a presença de anticorpos para uma proteína viral diferente, geralmente seria necessário para aumentar a precisão dos resultados gerais do teste.

Para esta página, o FDA resumiu o desempenho esperado dos testes que autorizou com base nas informações analisadas pelo FDA ao decidir se deve ou não conceder a esses testes uma Autorização de Uso de Emergência e assumindo uma prevalência de 5% para os cálculos de PPV e NPV.

Para testes que tiveram vários estudos de validação ou onde os testes mostraram desempenho variável em amostras coletadas em momentos diferentes após o início dos sintomas, os especialistas da FDA selecionaram os resultados que consideravam mais representativos do desempenho esperado dos testes. Esta é uma representação incompleta do desempenho desses testes.

Sempre consulte as instruções completas de uso para colocar essas estimativas no contexto apropriado e entender como usar e interpretar esses testes. A FDA também fornece uma calculadora que permitirá aos usuários ver o desempenho estimado de um único teste ou dois testes independentes com base em suas características de desempenho e na prevalência estimada de anticorpos SARS-CoV-2 na população-alvo.

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. The more samples used to validate a test, the smaller the confidence interval becomes, meaning that we can be more confident in the estimates of sensitivity and specificity provided.

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. A second test, typically one assessing for the presence of antibodies to a different viral protein, generally would be needed to increase the accuracy of the overall testing results.

For this page, FDA has summarized the expected performance of the tests it has authorized based on the information FDA reviewed when deciding whether or not to grant these tests an Emergency Use Authorization and assuming a prevalence of 5% for PPV and NPV calculations. For tests that had multiple validation studies or where the tests showed variable performance in samples collected at different times after symptom onset, FDA experts selected the results they considered to be most representative of expected test performance. This is an incomplete representation of the performance of these tests. Always refer to the complete instructions for use to put these estimates into the proper context and to understand how to use and interpret these tests. FDA also is providing a calculator that will allow users to see the estimated performance of a single test or two independent tests based on their performance characteristics and the estimated prevalence of SARS-CoV-2 antibodies in the target population.

Test Performance

Abbott Alinity i SARS-CoV-2 IgG

Developer: Abbott
Test: Alinity i SARS-CoV-2 IgG
Technology: High Throughput CMIA
Target: Nucleocapsid

Antibody

Performance Measure 

Estimate of Performance

95% Confidence Interval

IgG

Sensitivity (PPA)

100% (34/34)

(89.9%; 100%)

IgG

Specificity (NPA)

99.0% (99/100)

(94.6%; 99.8%)

IgG

PPV at prevalence = 5%

84.0%

(46.7%; 96.3%)

IgG

NPV at prevalence = 5%

100%

(99.4%; 100%)

Test Facts:

Abbott Architect SARS-CoV-2 IgG

Developer: Abbott
Test: Architect SARS-CoV-2 IgG
Technology: High Throughput CMIA
Target: Nucleocapsid

Antibody

Performance Measure 

Estimate of Performance

95% Confidence Interval

IgG

Sensitivity (PPA)

100% (88/88)

(95.8%; 100%)

IgG

Specificity (NPA)

99.6% (1066/1070)

(99.0%; 99.9%)

IgG

PPV at prevalence = 5%

92.9%

(83.4%; 98.1%)

IgG

NPV at prevalence = 5%

100%

(99.8%; 100%)

Test Facts:

Autobio Anti-SARS-CoV-2 Rapid Test

Developer: Autobio
Test: Anti-SARS-CoV-2 Rapid Test
Technology: Lateral Flow
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgM

Sensitivity (PPA)

95.7% (289/302)

(92.8%; 97.5%)

IgM

Specificity (NPA)

99.7% (311/312)

(98.2%; 99.9%)

IgG

Sensitivity (PPA)

99.0% (299/302)

(97.1%; 99.7%)

IgG

Specificity (NPA)

99.4% (310/312)

(97.7%; 99.8%)

Combined

Sensitivity (PPA)

99.0% (299/302)

(97.1%; 99.7%)

Combined

Specificity (NPA)

99% (309/312)

(97.2%; 99.7%)

Combined

PPV at prevalence = 5%

84.4%

(64.6%; 94.6%)

Combined

NPV at prevalence = 5%

99.9%

(99.8%; 100%)

Test Facts:

Bio-Rad Platelia SARS-CoV-2 Total Ab

Developer: Bio-Rad Laboratories, Inc
Test: Platelia SARS-CoV-2 Total Ab
Technology: ELISA
Target: Nucleocapsid

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

92.2% (47/51)

(81.5%; 96.9%)

Pan-Ig

Specificity (NPA)

99.6% (684/687)

(98.7%; 99.9%)

Pan-Ig

PPV at prevalence = 5%

91.7%

(76.7%; 98.1%)

Pan-Ig

NPV at prevalence = 5%

99.6%

(99.0%; 99.8%)

Test Facts:

Cellex qSARS-CoV-2 IgG/IgM Rapid Test

Developer: Cellex, Inc.
Test: qSARS-CoV-2 IgG/IgM Rapid Test
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Combined

Sensitivity (PPA)

93.8% (120/128)

(88.2%; 96.8%)

Combined

Specificity (NPA)

96.0% (240/250)

(92.8%; 97.8%)

Combined

PPV at prevalence = 5%

55.2%

(39.2%; 69.8%)

Combined

NPV at prevalence = 5%

99.7%

(99.3%; 99.8%)

Test Facts:

DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG

Developer: DiaSorin
Test: LIAISON SARS-CoV-2 S1/S2 IgG
Technology: High Throughput CMIA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgG

Sensitivity (PPA)

97.6% (40/41)

(87.4%; 99.6%)

IgG

Specificity (NPA)

99.3% (1082/1090)

(98.6%; 99.6%)

IgG

PPV at prevalence = 5%

88.0%

(76.7%; 92.9%)

IgG

NPV at prevalence = 5%

99.9%

(99.3%; 100%)

Test Facts:

Emory Medical Laboratories SARS-CoV-2 RBD IgG test

Developer: Emory Medical Laboratories
Test: SARS-CoV-2 RBD IgG test
Technology: ELISA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgG

Sensitivity (PPA)

100% (30/30)

(88.7%; 100%)

IgG

Specificity (NPA)

96.4% (615/638)

(94.6%; 97.6%)

IgG

PPV at prevalence = 5%

59.3%

(46.6%; 68.6%)

IgG

NPV at prevalence = 5%

100%

(99.4%; 100%)

Test Facts:

EUROIMMUN SARS-COV-2 ELISA (IgG)

Developer: EUROIMMUN
Test: SARS-COV-2 ELISA (IgG)
Technology: ELISA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgG

Sensitivity

90.0% (27/30)

(74.4%; 96.5%)

IgG

Specificity

100% (80/80)

(95.4%; 100%)

IgG

PPV at prevalence = 5%

100%

(46.0%; 100%)

IgG

NPV at prevalence = 5%

99.5%

(98.6%; 99.8%)

Test Facts:

Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette

Developer: Hangzhou Biotest Biotech
Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgM

Sensitivity

100% (30/30)

(88.7%; 100%)

IgM

Specificity

100% (80/80)

(95.4%; 100%)

IgG

Sensitivity

93.3% (28/30)

(78.7%; 98.2%)

IgG

Specificity

100% (80/80)

(95.4%; 100%)

Combined

Sensitivity

100% (30/30)

(88.7%; 100%)

Combined

Specificity

100% (80/80)

(95.4%; 100%)

Combined

PPV at prevalence = 5%

100%

(50.5%; 100%)

Combined

NPV at prevalence = 5%

100%

(99.4%; 100%)

Test Facts:

Healgen COVID-19 IgG/IgM Rapid Test Cassette

Developer: Healgen
Test: COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgM

Sensitivity

100% (30/30)

(88.7%; 100%)

IgM

Specificity

100% (80/80)

(95.4%; 100%)

IgG

Sensitivity

96.7% (29/30)

(83.3%; 99.4%)

IgG

Specificity

97.5% (78/80)

(91.3%; 99.3%)

Combined

Sensitivity

100% (30/30)

(88.7%; 100%)

Combined

Specificity

97.5% (78/80)

(91.3%; 99.3%)

Combined

PPV at prevalence = 5%

67.8%

(35.0%; 88.4%)

Combined

NPV at prevalence = 5%

100%

(99.4%; 100%)

Test Facts:

InBios SCoV-2 Detect IgG ELISA

Developer: InBios
Test: SCoV-2 Detect IgG ELISA
Technology: ELISA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgG

Sensitivity (PPA)

97.8% (44/45)

(88.4%; 99.6%)

IgG

Specificity (NPA)

99.0% (94/95)

(94.3%; 99.8%)

IgG

PPV at prevalence = 5%

83.1%

(44.9%; 96.6%)

IgG

NPV at prevalence = 5%

99.9%

(99.4%; 100%)

Test Facts:

Mount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody Test

Developer: Mount Sinai Hospital Clinical Laboratory
Test: Mt. Sinai Laboratory COVID-19 ELISA Antibody Test
Technology: 2-Step ELISA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Combined

Sensitivity (PPA)

92.5% (37/40)

(80.1%; 97.4%)

Combined

Specificity (NPA)

100% (74/74)

(95.1%; 100%)

Combined

PPV at prevalence = 5%

100%

(46.2%; 100%)

Combined

NPV at prevalence = 5%

99.6%

(98.9%; 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 test
Technology: High Throughput CLIA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

IgG

Sensitivity (PPA)

90.0% (36/40)

(76.9%; 96.0%)

IgG

Specificity (NPA)

100% (407/407)

(99.1%; 100%)

IgG

PPV at prevalence = 5%

100%

(81.8%; 100%)

IgG

NPV at prevalence = 5%

99.5%

(98.8%; 99.7%)

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 Calibrator
Technology: High Throughput CLIA
Target: Spike

Antibody

Performance Measure

Estimate of Performance 

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

100% (49/49)

(92.7%; 100%)

Pan-Ig

Specificity (NPA)

100% (400/400)

(99.0%; 100%)

Pan-Ig

PPV at prevalence = 5%

100%

(83.0.%; 100%)

Pan-Ig

NPV at prevalence = 5%

100%

(99.6%; 100%)

Test Facts:

Roche Elecsys Anti-SARS-CoV-2

Developer: Roche
Test: Elecsys Anti-SARS-CoV-2
Technology: High Throughput ECLIA
Target: Nucleocapsid

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

100% (29/29)

(88.3%; 100%)

Pan-Ig

Specificity (NPA)

99.8% (5262/5272)

(99.7%; 99.9%)

Pan-Ig

PPV at prevalence = 5%

96.5%

(93.9%; 98.1%)

Pan-Ig

NPV at prevalence = 5%

100%

(99.4%; 100%)

Test Facts:

Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: ADVIA Centaur SARS-CoV-2 Total (COV2T)
Technology: High Throughput CMIA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

100% (47/47)

(92.4%; 100%)

Pan-Ig

Specificity (NPA)

99.8% (1586/1589)

(99.4%; 99.9%)

Pan-Ig

PPV at prevalence = 5%

96.5%

(89.8%; 98.8%)

Pan-Ig

NPV at prevalence = 5%

100%

(99.6%; 100%)

Test Facts:

Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: Atellica IM SARS-CoV-2 Total (COV2T)
Technology: High Throughput CMIA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

100% (42/42)

(91.6%; 100%)

Pan-Ig

Specificity (NPA)

99.8% (1089/1091)

(99.3%; 99.9%)

Pan-Ig

PPV at prevalence = 5%

96.7%

(87.9%; 99.1%)

Pan-Ig

NPV at prevalence = 5%

100%

(99.6%; 100%)

Test Facts:

Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)

Developer: Siemens Healthcare Diagnostics
Test: Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
Technology: High Throughput ELISA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

100% (79/79)

(95.4%; 100%)

Pan-Ig

Specificity (NPA)

99.9% (1527/1529)

(99.5%; 100%)

Pan-Ig

PPV at prevalence = 5%

97.6%

(91.3%; 99.3%)

Pan-Ig

NPV at prevalence = 5%

100%

(99.8%; 100%)

Test Facts:

Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
Technology: High Throughput ELISA
Target: Spike

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

100% (79/79)

(95.4%; 100%)

Pan-Ig

Specificity (NPA)

99.8% (1526/1529)

(99.4%; 99.9%)

Pan-Ig

PPV at prevalence = 5%

96.3%

(89.7%; 98.7%)

Pan-Ig

NPV at prevalence = 5%

100%

(99.8%; 100%)

Test Facts:

Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay

Developer: Vibrant America Clinical Labs
Test: Vibrant COVID-19 Ab Assay
Technology: High Throughput CLIA
Target: Spike and Nucleocapsid

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Combined

Sensitivity (PPA)

98.1% (52/53)

(90.1%; 99.7%)

Combined

Specificity (NPA)

98.6% (494/501)

(97.1%; 99.3%)

Combined

PPV at prevalence = 5%

78.7%

(62.4%; 88.6%)

Combined

NPV 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 Health
Test: New York SARS-CoV Microsphere Immunoassay for Antibody Detection
Technology: MIA
Target: Nucleocapsid

Antibody

Performance Measure

Estimate of Performance

95% Confidence Interval

Pan-Ig

Sensitivity (PPA)

88.0% (95/108)

(80.5%; 92.8%)

Pan-Ig

Specificity (NPA)

98.8% (428/433)

(97.3%; 99.5%)

Pan-Ig

PPV at prevalence = 5%

79.4%

(61.1%; 90.7%)

Pan-Ig

NPV at prevalence = 5%

99.4%

(99.0%; 99.6%)

Test Facts:

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). See Recognized Consensus Standards. Confidence intervals for PPV and NPV were calculated using the values from the 95% confidence intervals for sensitivity and specificity.

 

 

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