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Diagnostic Performance of RT-PCR-Based Sample Pooling Strategy for the Detection of SARS-CoV-2 (preprint)
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-292590
ABSTRACT

Background:

The rapid spread of SARS-CoV-2 has created a shortage of supplies of reagents for its detection throughout the world, especially in Latin America. The pooling of samples consists of combining individual patient samples in a block and analyzing the group as a particular sample. This strategy has been shown to reduce the burden of laboratory material and logistical resources by up to 80%. Therefore, we aimed to evaluate the diagnostic performance of the pool of samples analyzed by RT-PCR to detect SARS-CoV-2.

Methods:

A cross-sectional study of diagnostic tests was carried out. We individually evaluated 420 samples, and 42 clusters were formed, each one with ten samples. These clusters could contain 0, 1 or 2 positive samples to simulate a positivity of 0, 10 and 20%, respectively. RT-PCR analyzed the groups for the detection of SARS-CoV-2. The area under the ROC curve (AUC), the Youden index, the global and subgroup Sensitivity and specificity were calculated according to their Ct values that were classified as high (H ≤25), moderate (M 26-30) and low (L 31-35) concentration of viral RNA.

Results:

From a total of 42 pools, 41 (97.6%) obtained the same result as the samples they contained (positive or negative). The AUC for pooling, Youden index, sensitivity, and specificity were 0.98 (95% CI, 0.95-1);0.97 (95% CI, 0.90-1.03);96.67% (95% CI;88.58-100%) and 100% (95% CI;95.83-100%) respectively. In the stratified analysis of the pools containing samples with CT <31, the Sensitivity was 100% (95% CI;90-100%), while with the pools containing samples with Ct ≥31, the Sensitivity was 80% (95% CI, 34.94% - 100%). Finally, a median greater than 2.32 (IQR 1.12 - 3.03) in the Ct was observed in the pools concerning the Ct of the individual samples (p <0.001).

Conclusions:

The strategy of pooling nasopharyngeal swab samples for analysis by SARS-CoV-2 RT-PCR showed high diagnostic performance.

Full text: Available Collection: Preprints Database: EuropePMC Language: English Year: 2021 Document Type: Preprint

Full text: Available Collection: Preprints Database: EuropePMC Language: English Year: 2021 Document Type: Preprint