两种聚合酶链反应检测方法（达安基因（达安基因2019-ncov）和赛沛（赛沛Xpert Xpress SARS-CoV-2））在喀麦隆雅温得对新冠病毒Delta和Omicron变异株检测的比较。
Comparison of two polymerase chain reaction assays, DaAn Gene (DaAn Gene 2019-ncov) and Cepheid (Cepheid Xpert Xpress SARS-CoV-2) for Delta and Omicron variants of SARS-CoV-2 detection in Yaoundé, Cameroon.
作者信息
Maidadi-Foudi Martin, Atsama-Amougou Marie, Godwe Celestin, Guichet Emilande, Boutgam Nadine L, Metomo Guy Roland Awoundza, Hamadama Oumarou Goni, Woguia Gilles-Fils, Ngoume Yannick F, Djomsi Dowbiss Meta, Djounda Roméo Brice D, Ngamaleu Modeste, Tene Hillary, Esemu Livo, Fokam Joseph, Okomo Marie-Claire, Onana Boyomo, Mbacham Wilfred, Tongo Marcel, Delaporte Eric, Peeters Martine, Ayouba Ahidjo, Kouanfack Charles
机构信息
Centre for Research on Emerging and Re-emerging Diseases (CREMER), Institute of Medical Research and Medicinal Plants Studies (IMPM), Yaoundé, Cameroon.
Department of Microbiology, Faculty of Science, University of Yaoundé I, Yaoundé, Cameroon.
出版信息
J Public Health Afr. 2025 Jul 31;16(1):1282. doi: 10.4102/jphia.v16i1.1282. eCollection 2025.
BACKGROUND
New severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants may affect diagnostic test accuracy.
AIM
To evaluate the performance of two reverse transcription-polymerase chain reaction (RT-PCR) assays, DaAn Gene and Cepheid, for detecting Delta and Omicron variants.
SETTING
Nasopharyngeal samples were collected in Yaoundé, Cameroon, between October 2021 and December 2022.
METHODS
Nasopharyngeal samples were tested with both assays. Samples with a cycle threshold (CT) ≤ 28 were sequenced. Cohen's kappa coefficient assessed assay agreement.
RESULTS
We compared 294 samples. At CT ≤ 40, DaAn Gene showed a 59.2% ( = 174/294) positivity rate versus 57.8% ( = 170/294) for Cepheid (χ = 0.695, = 0.4044). Agreement was 95.91% ( = 282/294) with κ = 0.95. DaAn Gene showed a 58.2% ( = 171/294) positivity rate versus 54.4% ( = 160/294) for Cepheid at CT ≤ 37 ( = 0.5058), with 95.6% agreement (κ = 0.95). At CT ≤ 33, DaAn Gene was 56.5% ( = 166/294) positive versus 54.1% ( = 159/294) for Cepheid ( = 0.6187), with 96.93% agreement (κ = 0.938). For 167 samples with CT ≤ 28, agreement was 97.0% (κ = 0.97) across variants. These RT-PCR assays effectively detected Delta and Omicron variants.
CONCLUSION
The emergence of Delta and Omicron variants did not significantly impact the diagnostic performance of these routine RT-PCR assays.
CONTRIBUTION
This study confirms their continued effectiveness in detecting these variants in this setting.
背景
新型严重急性呼吸综合征冠状病毒2（SARS-CoV-2）变体可能会影响诊断测试的准确性。
目的
评估两种逆转录-聚合酶链反应（RT-PCR）检测方法，即达安基因和赛沛，对检测德尔塔和奥密克戎变体的性能。
地点
2021年10月至2022年12月期间在喀麦隆雅温得采集鼻咽样本。
方法
两种检测方法均对鼻咽样本进行检测。对循环阈值（CT）≤28的样本进行测序。采用科恩kappa系数评估检测方法的一致性。
结果
我们比较了294个样本。在CT≤40时，达安基因的阳性率为59.2%（=174/294），而赛沛为57.8%（=170/294）（χ²=0.695，P=0.4044）。一致性为95.91%（=282/294），κ=0.95。在CT≤37时，达安基因的阳性率为58.2%（=171/294），而赛沛为54.4%（=160/294）（χ²=0.5058），一致性为95.6%（κ=0.95）。在CT≤33时，达安基因的阳性率为56.5%（=166/294），而赛沛为54.1%（=159/294）（χ²=0.6187），一致性为96.93%（κ=0.938）。对于167个CT≤个样本，各变体间的一致性为97.0%（κ=0.97）。这些RT-PCR检测方法有效地检测了德尔塔和奥密克戎变体。
结论
德尔塔和奥密克戎变体的出现并未显著影响这些常规RT-PCR检测方法的诊断性能。
贡献
本研究证实了它们在此环境中检测这些变体的持续有效性。
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