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Article ; Online: External quality assessment program for human papillomaviruses DNA testing in Thailand

Pilailuk Akkapaiboon Okada / Suratchana Mitrat / Archawin Rojanawiwat

Practical Laboratory Medicine, Vol 38, Iss , Pp e00352- (2024)

2024

Abstract: Background: Since 2020, the National Health Security Office includes the human papillomavirus DNA testing for cervical cancer screening in the government's healthcare schemes. HPV DNA testing has become primary screening in many laboratories in Thailand. ...

Abstract	Background: Since 2020, the National Health Security Office includes the human papillomavirus DNA testing for cervical cancer screening in the government's healthcare schemes. HPV DNA testing has become primary screening in many laboratories in Thailand. External quality assurance scheme is crucial for assessment of laboratory performance. Objectives: The aim of this study was to develop a pilot program using LBC samples for the EQA of molecular methods and to review the methods used by participants to detect the presence of high risk HPV genotypes. Study design: Four pilot distributions were shipped between December 2021 and May 2023, six months apart of two panels, each consisting of five different specimens. Results: All participants achieved 100 % accuracy in correctly identifying the presence or absence of high-risk genotypes in all 5 EQA samples. The most used HPV DNA test for detecting the presence of high-risk HPV DNA was the two specific high-risk genotypes and 12 other high-risk HPV genotypes. There was an observed increase in the use of assays that could detect 14 HPV HR genotypes. It suggests expanding testing methods to include a broader range of high-risk HPV genotypes, which could improve the comprehensiveness of the testing. Conclusions: The HPV DNA testing scheme provides a standardised, homogeneous and characterised clinical specimen. These results indicate that the LBC samples are suitable for utilisation in an EQA scheme. EQA of HPV molecular screening programme is essential for monitoring the performance of laboratory networks.
Keywords	Human papillomavirus ; High risk genotypes ; Thailand ; Medicine (General) ; R5-920 ; Chemistry ; QD1-999
Subject code	630
Language	English
Publishing date	2024-01-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
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Article: External quality assessment program for human papillomaviruses DNA testing in Thailand.

Okada, Pilailuk Akkapaiboon / Mitrat, Suratchana / Rojanawiwat, Archawin

Practical laboratory medicine

2023 Volume 38, Page(s) e00352

Abstract	Background: Since 2020, the National Health Security Office includes the human papillomavirus DNA testing for cervical cancer screening in the government's healthcare schemes. HPV DNA testing has become primary screening in many laboratories in Thailand. External quality assurance scheme is crucial for assessment of laboratory performance. Objectives: The aim of this study was to develop a pilot program using LBC samples for the EQA of molecular methods and to review the methods used by participants to detect the presence of high risk HPV genotypes. Study design: Four pilot distributions were shipped between December 2021 and May 2023, six months apart of two panels, each consisting of five different specimens. Results: All participants achieved 100 % accuracy in correctly identifying the presence or absence of high-risk genotypes in all 5 EQA samples. The most used HPV DNA test for detecting the presence of high-risk HPV DNA was the two specific high-risk genotypes and 12 other high-risk HPV genotypes. There was an observed increase in the use of assays that could detect 14 HPV HR genotypes. It suggests expanding testing methods to include a broader range of high-risk HPV genotypes, which could improve the comprehensiveness of the testing. Conclusions: The HPV DNA testing scheme provides a standardised, homogeneous and characterised clinical specimen. These results indicate that the LBC samples are suitable for utilisation in an EQA scheme. EQA of HPV molecular screening programme is essential for monitoring the performance of laboratory networks.
Language	English
Publishing date	2023-12-26
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2834973-8
ISSN	2352-5517
ISSN	2352-5517
DOI	10.1016/j.plabm.2023.e00352
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Article ; Online: Higher correlation between neutralizing antibodies and surrogate neutralizing or binding antibodies in COVID-19 patients than vaccine recipients.

Lerdsamran, Hatairat / Anusorntanawat, Ratikorn / Sangsiriwut, Kantima / Sawadpongpan, Suteema / Prasertsopon, Jarunee / Thinpan, Nattakarn / Intalapaporn, Poj / Techasuwanna, Ranida / Okada, Pilailuk / Puthavathana, Pilaipan

PloS one

2024 Volume 19, Issue 4, Page(s) e0298033

Abstract: This study determined the seropositive rates and levels of antibodies to severe acute respiratory syndrome coronavirus-2 in 50 patients and 108 vaccinees using microneutralization test (MNT), surrogate virus neutralization test (sVNT), chemiluminescent ... ...

Abstract	This study determined the seropositive rates and levels of antibodies to severe acute respiratory syndrome coronavirus-2 in 50 patients and 108 vaccinees using microneutralization test (MNT), surrogate virus neutralization test (sVNT), chemiluminescent microparticle immunoassay (CMIA), and electrochemiluminescence immunoassay (ECLIA). MNT, as the reference method, employed living clade S and Delta viruses to measure neutralizing (NT) antibodies, while sVNT employed wild type strain and Delta receptor-binding domains (RBD) as the test antigens to measure sVNT antibodies. CMIA and ECLIA employed only one version of RBD to measure the binding antibodies. Our study performed S gene sequencing of the test virus to exclude undesired mutants that might lead to changes in antibody levels in MNT assay. We showed that spike protein amino acid sequences of our Delta virus contained 13 amino acid changes, with 3 related to the reduced neutralization. The MNT assay showed a significant reduction in seropositive rates and antibody levels in the patients' sera when the Delta variant replaced clade S as the test virus. In contrast, the seropositive rates determined by sVNT assay using wild type strain RBD and Delta RBD were non-significantly different, suggesting that sVNT assay could not identify the difference between the antigenicity of wild type RBD and Delta RBD. Furthermore, the correlation between the levels of NT and sVNT antibodies was moderate with the patients' sera but modest with the post-vaccination sera. The seropositive rates in the patients, as determined by CMIA or ECLIA, were not different from the MNT assay using clade S, but not Delta, as the test virus. In all analyses, the correlations between the antibody levels measured by MNT and the other 3 assays were modest to moderate, with the r-values of 0.3500-0.7882.
MeSH term(s)	Humans ; Antibodies, Neutralizing ; COVID-19 ; SARS-CoV-2 ; Vaccines ; Antibodies, Viral ; Neutralization Tests
Chemical Substances	Antibodies, Neutralizing ; Vaccines ; Antibodies, Viral
Language	English
Publishing date	2024-04-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0298033
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Article ; Online: Applicability of a colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for SARS-CoV-2 detection in high exposure risk setting.

Nuchnoi, Pornlada / Piromtong, Pakorn / Siribal, Saranya / Anansilp, Korrarit / Thichanpiang, Peeradech / Okada, Pilailuk Akkapaiboon

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

2023 Volume 128, Page(s) 285–289

Abstract: Objectives: During the third wave, the growing number of COVID-19 case clusters reported countrywide in Thailand demonstrated the rapidly evolving characteristics of SARS-CoV-2, the causative agent of the COVID-19 pandemic. The rapid spread of COVID-19 ... ...

Abstract	Objectives: During the third wave, the growing number of COVID-19 case clusters reported countrywide in Thailand demonstrated the rapidly evolving characteristics of SARS-CoV-2, the causative agent of the COVID-19 pandemic. The rapid spread of COVID-19 infections had been extensively reported in public areas and construction camps, as well as in congested communities with poor sanitation. High demand for SARS-CoV-2 genome testing and quick reporting by an hour for case identification and isolation characterizes the COVID-19 crisis in Thailand. This situation leads to an urgent need for alternative molecular tests which are reliable, rapid, and cost-effective. Methods: In this study, we assessed colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP), using real-time reverse transcription-polymerase chain reaction (RT-PCR) as a reference standard, for active case finding in suspected (mostly asymptomatic) cases living in high-risk areas of Bangkok. Results: The diagnostic performance of the RT-LAMP compared with real-time RT-PCR in specimens from 549 Thais were computed in a real-world field study setting. Our study demonstrated that RT-LAMP achieved robust identification of SARS-CoV-2 infection, with a diagnostic sensitivity and specificity of 91.67% and 100%, respectively. Conclusion: RT-LAMP is a reliable assay for SARS-CoV-2 detection and is scalable for use in the emergency response to a nationwide pandemic, despite resource limitations. The RT-LAMP real-world data derived from this field study validate its potential use in laboratory practice. RT-LAMP is a good choice as a laboratory-based SARS-CoV-2 molecular test when real-time RT-PCR is not available.
MeSH term(s)	Humans ; SARS-CoV-2/genetics ; COVID-19 ; Reverse Transcription ; Pandemics ; Colorimetry ; Thailand ; Molecular Diagnostic Techniques ; Nucleic Acid Amplification Techniques ; Sensitivity and Specificity ; RNA, Viral/genetics
Chemical Substances	RNA, Viral
Language	English
Publishing date	2023-01-13
Publishing country	Canada
Document type	Journal Article
ZDB-ID	1331197-9
ISSN	1878-3511 ; 1201-9712
ISSN (online)	1878-3511
ISSN	1201-9712
DOI	10.1016/j.ijid.2023.01.010
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Article ; Online: Impact of Omicron variant sublineage BA.2.75 on the OnSite COVID-19 Ag Rapid Test: the applicability of rapid antigen test with universal transport media.

Okada, Pilailuk Akkapaiboon / Nuchnoi, Pornlada / Buayai, Kampaew / Phuygun, Siripaporn / Thongpramul, Nuttida / Plabplueng, Chotiros / Rojanawiwat, Archawin / Uppapong, Ballang / Sirilak, Supakit

Infectious diseases (London, England)

2023 Volume 56, Issue 2, Page(s) 138–144

Abstract: Background: Rapid antigen testing (RAT) is one of the most powerful tools for SARS-CoV-2 detection. The OnSite COVID-19 Ag Rapid Test is an antigen-based, point-of-care test approved by the WHO for Emergency Use Listing. The : Objective: To ensure ... ...

Abstract	Background: Rapid antigen testing (RAT) is one of the most powerful tools for SARS-CoV-2 detection. The OnSite COVID-19 Ag Rapid Test is an antigen-based, point-of-care test approved by the WHO for Emergency Use Listing. The Objective: To ensure the diagnostic performance of the study RAT during rapidly mutated Omicron variants. Results: We independently evaluated the performance of this assay in 1098 archived samples collected in Thailand during October 2022-February 2023, which were 798 and 300 COVID-19 real-time RT-PCR positive and negative, respectively. The assay performed with 100% sensitivity and 100% specificity using a cycle threshold (Ct) of <20 for the RT-PCR. The sensitivity decreased to 88% when using Ct <30. Most of the SARS-CoV-2 found were Omicron BA.2 (99%), harboring six known Conclusions: These results confirmed the good performance of the study RAT for detecting Omicron variants and its appropriateness for individual diagnosis and for genomic surveillance.
MeSH term(s)	Humans ; COVID-19/diagnosis ; SARS-CoV-2/genetics ; Mutation ; Real-Time Polymerase Chain Reaction
Language	English
Publishing date	2023-12-18
Publishing country	England
Document type	Journal Article
ZDB-ID	2839775-7
ISSN	2374-4243 ; 2374-4235
ISSN (online)	2374-4243
ISSN	2374-4235
DOI	10.1080/23744235.2023.2280025
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Article ; Online: Emergence of Vibrio parahaemolyticus serotype O10:K4 in Thailand.

Okada, Kazuhisa / Roobthaisong, Amonrattana / Hearn, Suthida Muangnoicharoen / Okada, Pilailuk Akkapaiboon / Doung-Ngern, Pawinee / Wongboot, Warawan / Nakkarach, Atchareeya / Morita, Masatomo / Kodama, Toshio / Iida, Tetsuya

Microbiology and immunology

2023 Volume 67, Issue 4, Page(s) 201–203

Abstract: An emerging serotype O10:K4 of Vibrio parahaemolyticus has been predominantly isolated from outbreaks and sporadic cases in China. Herein, we report the first case of infection due to V. parahaemolyticus O10:K4 isolated from a hospitalized patient with ... ...

Abstract	An emerging serotype O10:K4 of Vibrio parahaemolyticus has been predominantly isolated from outbreaks and sporadic cases in China. Herein, we report the first case of infection due to V. parahaemolyticus O10:K4 isolated from a hospitalized patient with acute diarrhea in Thailand. We sequenced the whole genome of the O10:K4 strain and compared it with those of the pandemic O3:K6 strain, O10:K4 strains in China, and other clinical and environmental strains. The results suggested that the O10:K4 strains are not a mere serotype variant diverged from the pandemic O3:K6 strain, confirming that the O10:K4 strain emergence has spread to Southeast Asia.
MeSH term(s)	Humans ; Serogroup ; Vibrio parahaemolyticus/genetics ; Thailand ; Vibrio Infections/epidemiology ; Diarrhea ; Disease Outbreaks ; Serotyping
Language	English
Publishing date	2023-02-04
Publishing country	Australia
Document type	Case Reports ; Journal Article
ZDB-ID	224792-6
ISSN	1348-0421 ; 0385-5600
ISSN (online)	1348-0421
ISSN	0385-5600
DOI	10.1111/1348-0421.13055
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Article ; Online: First Round of External Quality Assessment Scheme for SARS-CoV-2 Laboratories During the COVID-19 Pandemic in Thailand.

Saeng-Aroon, Siriphan / Changsom, Don / Boonmuang, Ratrawee / Waicharoen, Sunthareeya / Buayai, Kampaew / Okada, Pilailuk / Uppapong, Ballang / Chittaganpitch, Malinee / Soisangwan, Patravee / Praphasiri, Prabda / Skaggs, Beth A

Health security

2023 Volume 21, Issue 3, Page(s) 183–192

Abstract: The emergence of SARS-CoV-2 necessitated the rapid deployment of tests to diagnose COVID-19. To monitor the accuracy of testing across the COVID-19 laboratory network in Thailand, the Department of Medical Sciences under the Ministry of Public Health ... ...

Abstract	The emergence of SARS-CoV-2 necessitated the rapid deployment of tests to diagnose COVID-19. To monitor the accuracy of testing across the COVID-19 laboratory network in Thailand, the Department of Medical Sciences under the Ministry of Public Health launched a national external quality assessment (EQA) scheme using samples containing inactivated SARS-CoV-2 culture supernatant from a predominant strain in the early phase of the Thailand outbreak. All 197 laboratories in the network participated; 93% (n=183) of which reported correct results for all 6 EQA samples. Ten laboratories reported false-negative results, mostly for samples with low viral concentrations, and 5 laboratories reported false-positive results (1 laboratory reported false positives and false negatives). An intralaboratory investigation of 14 laboratories reporting incorrect results revealed 2 main causes of error: (1) RNA contamination of the rRT-PCR reaction and (2) poor-quality RNA extraction. Specific reagent combinations were significantly associated with false-negative reports. Thailand's approach to national EQA for SARS-CoV-2 can serve as a roadmap for other countries interested in implementing a national EQA program to ensure laboratories provide accurate testing results, which is crucial in diagnosis, prevention, and control strategies. A national EQA program can be less costly and thus more sustainable than commercial EQA programs. National EQA is recommended to detect and correct testing errors and provide postmarket surveillance for diagnostic test performance.
MeSH term(s)	Humans ; COVID-19 ; SARS-CoV-2/genetics ; Laboratories ; Pandemics/prevention & control ; Thailand/epidemiology ; RNA, Viral/genetics
Chemical Substances	RNA, Viral
Language	English
Publishing date	2023-05-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2823049-8
ISSN	2326-5108 ; 2326-5094
ISSN (online)	2326-5108
ISSN	2326-5094
DOI	10.1089/hs.2022.0117
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Article ; Online: Multiplex recombinase polymerase amplification for high-risk and low-risk type HPV detection, as potential local use in single tube.

Wongsamart, Rungdawan / Bhattarakasol, Parvapan / Chaiwongkot, Arkom / Wongsawaeng, Doonyapong / Okada, Pilailuk Akkapaiboon / Palaga, Tanapat / Leelahavanichkul, Asada / Khovidhunkit, Weerapan / Dean, Deborah / Somboonna, Naraporn

Scientific reports

2023 Volume 13, Issue 1, Page(s) 829

Abstract: High rates of new cervical cancer cases and deaths occur in low- and middle-income countries yearly, and one reason was found related to limitation of regular cervical cancer screening in local and low-resource settings. HPV has over 150 types, yet ... ...

Abstract	High rates of new cervical cancer cases and deaths occur in low- and middle-income countries yearly, and one reason was found related to limitation of regular cervical cancer screening in local and low-resource settings. HPV has over 150 types, yet certain 14-20 high-risk and 13-14 low-risk types are common, and, thus, most conventional HPV nucleic acid assays, for examples, Cobas 4800 HPV test (Roche Diagnostics, New Jersey, USA) and REBA HPV-ID (Molecules and Diagnostics, Wonju, Republic of Korea) were developed to cover these types. We thereby utilized bioinformatics combined with recent isothermal amplification technique at 35-42 °C to firstly describe multiplex recombinase polymerase amplification assay that is specific to these common 20 high-risk and 14 low-risk types, and also L1 and E6/E7 genes that target different stages of cervical cancer development. Multiplex primer concentrations and reaction incubation conditions were optimized to allow simultaneous two gene detections at limit of detection of 1000 copies (equivalent to 2.01 fg) for L1 and 100 copies (0.0125 fg) for E6/E7, respectively. The assay was validated against urogenital and other pathogens, normal flora, and human control. In 130 real clinical sample tests, the assay demonstrated 100% specificity, 78% diagnostic accuracy, and 75% sensitivity compared with REBA HPV-ID test, and is much more rapid (15-40 min), less expensive (~ 3-4 USD/reaction) and does not require instrumentation (35-42 °C reaction condition so hand holding or tropical temperature is possible). Hence, the developed novel assay provides alternative screening tool for potential local screening. Furthermore, as this assay uses safe chemical reagents, it is safe for users.
MeSH term(s)	Female ; Humans ; Uterine Cervical Neoplasms/diagnosis ; Recombinases ; Papillomavirus Infections/diagnosis ; Early Detection of Cancer ; Nucleotidyltransferases ; Papillomaviridae/genetics ; Sensitivity and Specificity ; DNA, Viral/genetics
Chemical Substances	Recombinases ; Nucleotidyltransferases (EC 2.7.7.-) ; DNA, Viral
Language	English
Publishing date	2023-01-16
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-28038-9
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Article: Serological and Molecular Surveillance for SARS-CoV-2 Infection in Captive Tigers (

Sangkachai, Nareerat / Chaiwattanarungruengpaisan, Somjit / Thongdee, Metawee / Suksai, Parut / Tangsudjai, Siriporn / Wongluechai, Peerawat / Suwanpakdee, Sarin / Wiriyarat, Witthawat / Buddhirongawatr, Ruangrat / Prasittichai, Luxsana / Skulpong, Anurux / Okada, Pilailuk Akkapaiboon / Puthavathana, Pilaipan / Paungpin, Weena

Animals : an open access journal from MDPI

2022 Volume 12, Issue 23

Abstract: Coronavirus disease (COVID-19) is an emerging infectious disease caused by SARS-CoV-2. Given the emergence of SARS-CoV-2 variants, continuous surveillance of SARS-CoV-2 in animals is important. To monitor SARS-CoV-2 infection in wildlife in Thailand, we ... ...

Abstract	Coronavirus disease (COVID-19) is an emerging infectious disease caused by SARS-CoV-2. Given the emergence of SARS-CoV-2 variants, continuous surveillance of SARS-CoV-2 in animals is important. To monitor SARS-CoV-2 infection in wildlife in Thailand, we collected 62 blood samples and nine nasal- and rectal-swab samples from captive tigers (
Language	English
Publishing date	2022-11-29
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2606558-7
ISSN	2076-2615
ISSN	2076-2615
DOI	10.3390/ani12233350
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Article ; Online: Serological and Molecular Surveillance for SARS-CoV-2 Infection in Captive Tigers ( Panthera tigris ), Thailand

Nareerat Sangkachai / Somjit Chaiwattanarungruengpaisan / Metawee Thongdee / Parut Suksai / Siriporn Tangsudjai / Peerawat Wongluechai / Sarin Suwanpakdee / Witthawat Wiriyarat / Ruangrat Buddhirongawatr / Luxsana Prasittichai / Anurux Skulpong / Pilailuk Akkapaiboon Okada / Pilaipan Puthavathana / Weena Paungpin

Animals, Vol 12, Iss 3350, p

2022 Volume 3350

Abstract	Coronavirus disease (COVID-19) is an emerging infectious disease caused by SARS-CoV-2. Given the emergence of SARS-CoV-2 variants, continuous surveillance of SARS-CoV-2 in animals is important. To monitor SARS-CoV-2 infection in wildlife in Thailand, we collected 62 blood samples and nine nasal- and rectal-swab samples from captive tigers ( Panthera tigris ) in Ratchaburi province in Thailand during 2020–2021. A plaque reduction neutralization test (PRNT) was employed to detect SARS-CoV-2 neutralizing antibodies. A real-time RT-PCR assay was performed to detect SARS-CoV-2 RNA. Our findings demonstrated that four captive tigers (6.5%, 4/62) had SARS-CoV-2 neutralizing antibodies against Wuhan Hu-1 and the Delta variant, while no SARS-CoV-2 RNA genome could be detected in all swab samples. Moreover, a low-level titer of neutralizing antibodies against the Omicron BA.2 subvariant could be found in only one seropositive tiger. The source of SARS-CoV-2 infection in these tigers most likely came from close contact with the infected animals’ caretakers who engaged in activities such as tiger petting and feeding. In summary, we described the first case of natural SARS-CoV-2 infection in captive tigers during the COVID-19 outbreak in Thailand and provided seroepidemiological-based evidence of human-to-animal transmission. Our findings highlight the need for continuous surveillance of COVID-19 among the captive tiger population and emphasize the need to adopt a One Health approach for preventing and controlling outbreaks of COVID-19 zoonotic disease.
Keywords	captive tigers ; SARS-CoV-2 ; plaque reduction neutralization test ; surveillance ; Thailand ; Veterinary medicine ; SF600-1100 ; Zoology ; QL1-991
Subject code	630
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
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