Тесты на антитела к Ковид-19
May. 4th, 2020 03:55 pmПока оставляют желать лучшего.
Потому что дают 10-15% ложнопозитивных ответов.
Это много.
"Since the FDA issued its initial antibody test policy in mid-March, the agency said it has become aware of “a concerning number” of commercial serology tests being promoted inappropriately, including for diagnostic use, or performing poorly.
The FDA’s policy update comes too late as faulty and inaccurate tests have already flooded the market.
..some of the tests were extremely unreliable and could create a dangerous “false sense of security” for some Americans..
Не говоря уж о том, что рано использовать результаты этих тестов как критерий "для выхода из карантина" или "на работу" (возвращение к нормальной жизни)
"It's crucial that the tests work properly. A false positive -- telling someone they have antibodies when they don't -- could have grave consequences, since that person would then think they're immune to Covid-19 when they're not. "Having many inaccurate tests is worse than having no tests at all."
В США ФДА, сначала давшее "зеленый свет" компаниям, производящим киты для тестированияантител в крови, спохватилось, ввиду того, что качество (чувствительность, точность, специфичность, воспроизводимость) тестов оказалась никудышней.
"one of the reasons for the high false-positive rates is relaxed requirements from the US Food and Drug Administration.
In mid-March, when it became clear that Covid-19 was starting to whirl out of control, the FDA loosened its approval standards in order to get more antibody tests out on the market quickly.
The agency started to allow companies to sell tests without first providing evidence that they worked. Some 175 test developers have taken advantage of these new rules and can legally market their antibody tests without first having their validation data evaluated by the FDA."
После того, как киты (12, одобренных ФДА без проверок, для срочного применения) "проверили", с использованием крови образцов 2018 года, задолго до эпидемии Ковид-19, и грустная правда вышла наружу, ФДА срочно затребовала от производителей документацию об исследованиях, подтверждающую валидность, точность и воспроизводимость их тестов. Кто предоставит в течении 10 дней, тот и получит одобрение на рынок.
Кроме того, пока еще неясен вопрос и с ложно-негативными резульатами тестов.
"The researchers also checked whether the tests accurately detected positive samples, but are less confident about those results, "
Потому что дают 10-15% ложнопозитивных ответов.
Это много.
"Since the FDA issued its initial antibody test policy in mid-March, the agency said it has become aware of “a concerning number” of commercial serology tests being promoted inappropriately, including for diagnostic use, or performing poorly.
The FDA’s policy update comes too late as faulty and inaccurate tests have already flooded the market.
..some of the tests were extremely unreliable and could create a dangerous “false sense of security” for some Americans..
Dr. Scott Gottlieb, the former FDA commissioner, told CNBC that the tests have a high false-positive rate, making it difficult to know whether a single result is credible. He said the likely accuracy of the test increases if the same person gets two positive determinations in a row.
“Quite frankly, if it was me, I would repeat it three times,” said Gottlieb,
Не говоря уж о том, что рано использовать результаты этих тестов как критерий "для выхода из карантина" или "на работу" (возвращение к нормальной жизни)
"It's crucial that the tests work properly. A false positive -- telling someone they have antibodies when they don't -- could have grave consequences, since that person would then think they're immune to Covid-19 when they're not. "Having many inaccurate tests is worse than having no tests at all."
В США ФДА, сначала давшее "зеленый свет" компаниям, производящим киты для тестированияантител в крови, спохватилось, ввиду того, что качество (чувствительность, точность, специфичность, воспроизводимость) тестов оказалась никудышней.
"one of the reasons for the high false-positive rates is relaxed requirements from the US Food and Drug Administration.
In mid-March, when it became clear that Covid-19 was starting to whirl out of control, the FDA loosened its approval standards in order to get more antibody tests out on the market quickly.
The agency started to allow companies to sell tests without first providing evidence that they worked. Some 175 test developers have taken advantage of these new rules and can legally market their antibody tests without first having their validation data evaluated by the FDA."
После того, как киты (12, одобренных ФДА без проверок, для срочного применения) "проверили", с использованием крови образцов 2018 года, задолго до эпидемии Ковид-19, и грустная правда вышла наружу, ФДА срочно затребовала от производителей документацию об исследованиях, подтверждающую валидность, точность и воспроизводимость их тестов. Кто предоставит в течении 10 дней, тот и получит одобрение на рынок.
Кроме того, пока еще неясен вопрос и с ложно-негативными резульатами тестов.
"The researchers also checked whether the tests accurately detected positive samples, but are less confident about those results, "