first_imgA protracted battle between a Zika expert at the U.S. Centers for Disease Control and Prevention (CDC) and his superiors over tests for the virus came to light yesterday.The fracas centers on allegations by CDC’s Robert Lanciotti, chief of the Diagnostics and Reference Laboratory activity for mosquito-spread viruses in Fort Collins, Colorado. He alleges that the agency’s Emergency Operations Center (EOC) discounted his research in April and created “a public health threat” by relying on a less dependable human test for the Zika virus.As first reported by the The Washington Post, Carolyn Lerner, who heads the U.S. Office of Special Counsel, wrote President Barack Obama a detailed letter yesterday about the allegations. She also released several related reports, including an investigation conducted by the Department of Health and Human Services (HHS), and Lanciotti’s response. Lerner became involved after Lanciotti was demoted for his actions in May and filed a whistleblower suit. Her office “secured an agreement” with CDC to reinstate him as head of his lab. At the heart of the dispute is the fact that, in some people who become infected with Zika, viral levels in the blood remain relatively low, making the virus difficult to detect. Lanciotti alleged that a Zika test made by his lab, called Singleplex, was more sensitive than another test he initially helped devise, called Trioplex (which also tested for the related dengue and chikungunya viruses). Both tests rely on the polymerase chain reaction to amplify minute amounts of viral RNA. But Lanciotti said comparison tests in his lab, and a study conducted independently by the Blood Systems Research Institute in San Francisco, California, found that Trioplex failed to detect viral DNA in up to 39% of samples that the Singleplex test had indicated contained Zika.Officials at EOC, however, had confidence in the Trioplex test. They said it performed equally well as Singleplex in a comparative analysis conducted in a CDC lab in Puerto Rico.Concerned that state labs would abandon Singleplex for what he saw as the inferior Trioplex, Lanciotti on 21 April emailed 30 state labs, telling them that his lab was continuing to use Singleplex “due to its greater relative sensitivity.” One of the leaders of the EOC lab team told the HHS investigators that Lanciotti’s email “created more trouble and confusion than it clarified.”The HHS investigation team, which did not include CDC employees who worked in EOC or in the zoonotic infectious diseases branch, concluded on 2 September that evidence did not support Lanciotti’s allegations about Singleplex’s superiority, or that there was any specific danger to public health because of the use of Trioplex. The tests conducted in Puerto Rico, the report states, “produced the clearest, most complete, and most reproducible data available to the investigative team, [and] found no difference in sensitivity.” Even if data showing superiority of Singleplex were accurate, the investigators say the 39% “overstates the potential impact” of missed cases; clinicians use the test as only one indicator when making a Zika diagnosis, and if that’s factored in, the missed cases drop to a maximum of 12% even with the most discrepant tests. What’s more, only Trioplex was granted what’s known as “emergency use authorization” by the U.S. Food and Drug Administration.In addition to a lack of convincing evidence that Trioplex was inferior in comparative analyses, the investigators noted that the test was modified in August to include larger samples of blood or urine, as well as whole blood—all of which should contain higher levels of the Zika virus, making it easier to detect.In a stinging rebuttal Lanciotti submitted 15 September, he wrote that CDC needed to reevaluate the “entire EOC concept,” which he said relied on “relatively inexperienced individuals making critical decisions.” He stressed the Trioplex test also performed poorly in detection of the four different dengue virus strains in circulation. And he further criticized EOC for promoting “a questionable assay with misleading communications” and for not having “greater transparency.”Lerner’s letter stressed that “Lanciotti raises serious concerns about each of the CDC’s findings, including the methodology for discounting his research,” but she said the “matter is now closed.” Country * Afghanistan Aland Islands Albania Algeria Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Cote d’Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People’s Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People’s Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Martinique Mauritania Mauritius Mayotte Mexico Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Norway Oman Pakistan Palestine Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Qatar Reunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Vietnam Virgin Islands, British Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Emailcenter_img Sign up for our daily newsletter Get more great content like this delivered right to you! 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