|LETTER TO EDITOR
|Ahead of print publication
Initiation of COVID-19 testing by cartridge-based nucleic acid amplification test (Cepheid Xpress SARS-CoV-2): Our experience at a zonal hospital
Rajat Shukla1, Gurpreet Singh Bhalla2
1 Gastroenterology, Commandant, Military Hospital, Namkum, Ranchi, Jharkhand, India
2 Microbiology, Military Hospital, Namkum, Ranchi, Jharkhand, India
|Date of Submission||17-Jun-2020|
|Date of Decision||10-Jul-2020|
|Date of Acceptance||19-Jul-2020|
|Date of Web Publication||19-Aug-2020|
Gurpreet Singh Bhalla,
Military Hospital, Namkum, Ranchi, Jharkhand
Source of Support: None, Conflict of Interest: None
|How to cite this URL:|
Shukla R, Bhalla GS. Initiation of COVID-19 testing by cartridge-based nucleic acid amplification test (Cepheid Xpress SARS-CoV-2): Our experience at a zonal hospital. J Mar Med Soc [Epub ahead of print] [cited 2020 Sep 29]. Available from: http://www.marinemedicalsociety.in/preprintarticle.asp?id=292695
Coronavirus disease (COVID-19) outbreak caused by the novel coronavirus was declared a pandemic by the WHO on March 12, 2020., In our nation, as on July 12, 2020, we have a total of 291,058 active cases with 536,231 recovered patients. The pandemic has caused immense loss of lives, enormous devastation, and has affected lives globally.
Timely diagnosis of cases, besides other preventive measures, is one of the most important links in the chain of reducing the spread of COVID-19. It is of paramount importance, especially in hospitalized patients who can spread the disease to health-care workers and other contacts, resulting in loss of precious man-hours, panic, and even shutting down of hospitals with limited staff (e.g., zonal hospitals).
In a 492 bedded zonal hospital, owing to the ongoing pandemic, 204 beds in the hospital have been dedicated for COVID-19 patients. Nonavailability of in-house testing for COVID-19 resulted in the wastage of precious time, medical resources, and caused delay in decision-making.
Currently, ICMR has approved nucleic acid amplification tests (real-time reverse transcription-polymerase chain reaction [RT-PCR] and cartridge-based nucleic acid amplification test [CBNAAT] and Truenat™) and rapid antigen detection for diagnostic purpose. Nucleic acid testing modalities are confirmatory, but are expensive and require expertise. With RT-PCR, more than 90 samples can be processed at one time; however, it has a long turn-around-time, requires dedicated infra-structure and trained technicians. Thus, it is justifiable in hospitals with a large number of patients. CBNAAT and Truenat™have limited sample testing capacity; however, turn-around-time is very less, even single samples can be tested, and the results are available within 1 h. CBNAAT is a one-step confirmatory test, whereas Truenat™ is a two-step test, screening followed by confirmation. These testing methods do not require huge infra-structure and are ideal for zonal hospitals. Antigen detection is an easy to do point-of-care test, but a negative result needs to be reconfirmed by nucleic acid detection method. The results of each of the modalities need to be shared with ICMR on its portal on a daily basis. All the above modalities can only be used for testing the respiratory samples. As on date, ICMR has not approved serological methods for the clinical diagnosis of COVID-19.
In authors' institute, being a tuberculosis center, GeneXpert (proprietary equipment by Cepheid) was installed in the laboratory earlier this year for the rapid diagnosis of tuberculosis and rifampicin resistance. GeneXpert platform can also be used to detect HIV, HPV, HBV, H1N1 influenza virus, vancomycin resistance, and carbapenem resistance in bacteria, etc., besides tuberculosis, using dedicated cartridges. It was approved by the US-Food and Drug Administration in March 2020 and by ICMR in April 2020 for testing of COVID-19 patients. It is a closed system and reduces the risk of transmission of infection to laboratory staff during testing as opposed to conventional methods of testing. Cepheid Xpress SARS-CoV-2 is compatible with the existing GeneXpert equipment in zonal hospitals.
Owing to the existing equipment and requisite technical support, case was taken up with institute's directorate to permit the laboratory to apply for COVID-19 testing. On grant of permission, ICMR was approached for registration since the laboratory fulfilled the ICMR mandated criteria (i.e., a microbiologist, trained technicians, biosafety cabinet class 2, a robust biomedical waste disposal policy in accordance with current rules and a functional GeneXpert equipment). On online submission, application was scrutinized and ICMR contacted the institute to inspect the laboratory. After the team was satisfied, approval was given to procure the Cepheid Xpress SARS-CoV2 cartridges (kits for COVID-19 testing can only be procured after written permission from ICMR).
On receipt of test cartridges, the institute followed the ICMR instructed procedures for final approval. For that, the institute needs to get controls from nearest Virus Research and Diagnostic Laboratory (VRDL). The control samples are tested, and the results are shared with VRDL and ICMR. Once the team is satisfied with the accuracy of results, they register the laboratory and provide login credentials.
The laboratory conducted these mandated tests following which it was permitted to start testing clinical samples. The complete process took approximately 1 month. The steps for getting ICMR validation for hospital laboratory are simple, but procedures need to be followed strictly as per the appropriate guidelines. The daily feedback needs to be provided to ICMR, line directorate, and state authorities.
The hospital has started testing clinical samples and though the daily testing capacity is very less (a maximum of four samples per run), it has saved considerable resources and provides health-care workers with results in 1 h enabling timely decision-making. Hence, the authors recommend, that zonal hospitals having no infrastructure for RT-PCR should take up the case for COVID-19 testing by CBNAAT.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
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