Supporting Antigen-Detecting Rapid Diagnostic Testing Evaluation in Kenya
By Edwin Ochieng , country director , APHL Kenya ; Rufus Nyaga , deputy country director , APHL Kenya ; Samantha Musumeci , specialist , Global Health ; Ralph Timperi , senior advisor , Lab Practice & Management , Global Health ; Lucy Maryogo-Robinson , director , Global Health ; and Maria Landron , senior specialist , Global Health
Since the beginning of the COVID-19 pandemic , Kenya has relied primarily on real-time reverse transcriptionpolymerase chain reaction ( rRT-PCR ) tests to detect SARS-CoV-2 . There are a limited number of laboratories approved to perform these tests in the country and only 882,211 tests were conducted during nine months in 2021 out of a national population of approximately 50 million . A recent surge of infections underscored the need to increase testing capacity , reduce turnaround time ( TAT ) for result transmission and facilitate timely implementation of mitigation measures .
In an effort to implement antigendetecting rapid diagnostic testing ( Ag RDT ), the Kenya Medical Practitioners and Dentists Board ( KMPDB ) approved the Abbott PanBio™ Ag RDT as an option to meet some of its needs for detection of SARS-CoV-2 . APHL was called upon by the US Centers for Disease Control and Prevention
( CDC ) to support the PanBio™ Ag RDT field evaluation study for SARS-CoV-2 to assess its accuracy in Kenya .
An Ag RDT test sample is prepared : Photo : Rufus Nyaga
Study Implementation Road Map
A team of three officers consisting of the study coordinator , data manager and laboratory specialist led the field evaluation . The team developed the training curriculum and a field manual , which were reviewed by the study ’ s investigators and collaborators before the final approval by the principal investigators .
The project rollout involved a four-day training of surveillance officers , pilot testing at two sites and distribution of materials to study sites . The study team used a courier company to support the phased distribution of study materials as well as the daily shipment of specimens from study sites to two CDC-supported testing laboratories in Nairobi and Kisumu .
Study participants included individuals of all ages who presented with respiratory illness at any of the 12 study sites . Each site enrolled participants until the desired sample size of 2,300 total specimens from all sites was achieved . In prison and remand settings , enrollment included symptomatic inmates , close contacts of inmates testing positive in the prison and remand blocks , healthcare workers , and prison staff either changing shifts or reporting having close contact with a known case .
In addition , all persons within the community who , per the Ministry of Health ( MoH ) guidelines , were deemed to have been in close contact with a confirmed SARS-CoV-2 infected case were also invited to participate in this field evaluation .
Trained surveillance officers collected two nasopharyngeal ( NP ) specimens from each study participant . The first NP specimen was collected using a NP swab provided in the PanBio™ kit , while the second specimen was collected using a sterile flocked NP swab for rRT-PCR testing from the opposite nostril . The first NP specimen was immediately tested using Ag RDT kit while the second NP specimen was placed in viral transport media ( VTM ) and sent to the molecular testing laboratory in Nairobi or Kisumu within 24-96 hours of specimen collection .
Demographic and clinical information were collected electronically through the CommCare application installed on Android-operated tablets using a modified version of the MoH Case Investigation Form for COVID-19 . The Ag RDT and rRT-PCR results were then merged using a unique identification number and stored in a master database at the National Public Health Laboratory .
The study data is under final review and a final report is expected to be available by the end of 2021 . APHL was honored to have contributed to this field evaluation , the findings of which will contribute to public health policy , decision making and Kenya ’ s SARS-CoV-2 testing strategy . n