D.N. Patel, CJ.
1. This Public Interest Litigation has been preferred with the following prayers:-
“A. Issue a Writ of Mandamus or any other appropriate Writ, order or direction to the Respondents to issue appropriate guidelines with respect to priority testing, expeditious processing and declaration of results of pregnant women for Severe Acute Respiratory Syndrome Corona virus 2 (SARS CoV-2).
B. Pass such other and further order/orders as deemed fit and proper in the facts and circumstances of the present case and in the interest of justice.”
2. The petitioner has drawn the attention of the Court to the difficulties faced by pregnant women in testing for COVID-19 and processing of the results in a timely manner. According to the petitioner, most hospitals and nursing homes require pregnant women seeking admission for delivery to undergo COVID-19 test but the process of taking the sample, testing and obtaining the result takes considerable time [at least 5 days], during which time the woman is kept in isolation or with other untested persons. Further, as the validity of the tests is limited to a period of 5 to 7 days, the petitioner contends that the results often come after the validity of the sample has already lapsed, which necessitates further testing.
3. In response to the petition, an affidavit dated 22.06.2020 was filed on behalf of the Indian Council of Medical Research [hereinafter referred to as “ICMR”] in which ICMR has placed reliance upon its “Strategy for COVID-19 testing in India” (Version 5, dated 18.05.2020). It has also been mentioned that ICMR has issued an “Advisory on Use of Rapid Antigen Detection Test for COVID-19” dated 14.06.2020. These are in addition to the “Guidance for Management of Pregnant Women in COVID-19 Pandemic” dated 12.04.2020.
4. The strategy for COVID-19 testing in India dated 18.05.2020 states as follows:-
“1. All symptomatic (ILI symptoms) individuals with history of international travel in the last 14 days.
2. All symptomatic (ILI symptoms) contacts of laboratory confirmed cases.
3. All symptomatic (ILI symptoms) health care workers/ frontline workers involved in containment and mitigation of COVID19.
4. All patients of Severe Acute Respiratory Infection (SARI).
5. Asymptomatic direct and high-risk contacts of a confirmed case to be tested once between day 5 and day 10 of coming into contact.
6. All symptomatic ILI within hotspots/containment zones.
7. All hospitalized patients who develop ILI symptoms.
8. All symptomatic ILI among returnees and migrants within 7 days of illness.
9. No emergency procedure (including deliveries) should be delayed for lack of test. However, sample can be sent for testing if indicated as above (1-8), simultaneously.
* ILI case is defined as one with acute respiratory infection with fever = 38oC AND cough.
* SARI case is defined as one with acute respiratory infection with fever = 38oC AND cough AND requiring hospitalization.
* All testing in the above categories is recommended by real time RT-PCR test only.
* All changes incorporated in these guidelines as compared to the previous version have been indicated in bold.”
5. The relevant contents of the Advisory dated 14.06.2020 are as follows:-
1. Real time RT-PCR is the gold standard frontline test for diagnosis of COVID19. Various open and closed RT-PCR platforms (Open systems RT-PCR machines, TrueNat and CBNAAT) are currently being used for COVID19 diagnosis in India. All these platforms require specialized laboratory facilities in terms of equipment, biosafety & biosecurity. Minimum time taken for the test varies between different systems with a minimum of 2-5 hours including the time taken for sample transportation. These specifications limit the widespread use of the RT-PCR test and also impedes quick augmentation of testing capacity in various containment zones and hospital setting.
2. In view of this, there is urgent need of a reliable point-of-care rapid antigen detection test with good sensitivity and specificity for early detection of the disease.
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4. Brief description of the Standard Q COVID-19 Ag detection:
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v) Once the sample is collected in the extraction buffer, it is stable only for one hour. Therefore, the antigen test needs to be conducted at the site of sample collection in the healthcare setting. Transportation to the lab is not recommended.
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vii) The test can be interpreted as positive or negative after 15 minutes of putting the sample into the well by appearance of test and control lines, which can be read with a naked eye, requiring no specialized equipment. Maximum duration for interpreting a positive or negative test is 30 minutes. After that the test strip should be discarded.
6. Conclusion and Recommendations:
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iii) In view of its high specificity while relatively low sensitivity, ICMR recommends the use of Standard Q COVID-19 Ag detection assay as a point of care diagnostic assay for testing in the following settings in combination with the gold standard RT-PCR test:
A. Containment zones or hotspots (to be performed onsite under strict medical supervision and maintaining kit temperature between 2o to 30o C):
i) All symptomatic Influenza Like Illness(ILI).
ii) Asymptomatic direct and high-risk contacts with co-morbidities (lung disease, heart disease, liver disease, kidney disease, diabetes, neurological disorders, blood disorders) of a confirmed case to be tested once between day 5 and day 10 of coming into contact.
B. Healthcare settings (to be performed onsite under strict medical supervision and maintaining kit temperature between 2o to 3o C):
i) All symptomatic ILI patients presenting in a healthcare setting and are suspected of having COVID19 infection.
ii) Asymptomatic patients who are hospitalized or seeking hospitalization, in the following high-risk groups:
* Patients undergoing chemotherapy
* Immunosuppressed patients including those who are HIV+;
* Patients diagnosed with malignant disease;
* Transplant patients;
* Elderly patients (>65 yrs of age) with co-morbidities (lung disease, heart disease, liver disease, kidney disease, diabetes, neurological disorders, blood disorders)
iii) Asymptomatic patients undergoing aerosol generating surgical/non -surgical interventions:
* Elective/emergency surgical procedures like neurosurgery, ENT surgery, dental procedures;
* Non-surgical interventions like bronchoscopy, upper GI endoscopy and dialysis;
*ILI case is defined as one with acute respiratory infection with fever = 38?AND cough.
Use of the rapid antigen test is recommended in A & B categories above subject to the following conditions:
i) Suspected individuals who test negative for COVID-19 by rapid antigen test should be definitely tested sequentially by RT-PCR to rule out infection, whereas a positive test should be considered as a true positive and does not need reconfirmation by RT-PCR test.
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6. The Government of NCT of Delhi [hereinafter referred to as “GNCTD”] first placed on record a status report dated 07.07.2020 in which it was stated that all healthcare facilities have been directed to carry out compulsory Rapid Antigen Detection Testing for various categories of patients mentioned in its order dated 05.07.2020, which would also cover pregnant women. Ms. Shobhana Takiar, learned counsel for GNCTD, also drew our attention to an order dated 06.05.2020, whereby all COVID-19 testing labs have been inter alia directed to give reports of all samples collected within 24 hours and not later than 48 hours, in any case.
7. In order to rationalize the aforesaid guidelines, a comprehensive affidavit dated 13.07.2020 has been filed by the GNCTD in which it is inter alia stated as follows:
“5. In short, it is submitted that the outbreak of this pandemic has affected a large number of people and in India having huge population with limited resources, the respondent no. 2, Indian Council of Medical Research (ICMR) has recommended the strategy. For pregnant women in COVID-19, guidelines issued by ICMR are available at page 43 of the paperbook annexed by the petitioner. It is submitted that the guidelines issued by ICMR are for providing obstetric care for pregnant patients with confirmed novel Coronavirus disease (COVID-19) or pregnant person under investigation (PUI), i.e. who presents with symptoms.
6. In view of this all the pregnant women are not presumed to be COVID-19 positive. It is not mandatory for every pregnant woman to undergo COVID test unless and until she is confirmed COVID-19 contact or under investigation/suspect of COVID-19. Even as per the guidelines of ICMR at page 49, if a pregnant woman meets criteria for COVID-19 testing, she should be tested but obstetric management would not be delayed in order to test for COVID-19.
7. That the answering respondent craves liberty to reiterate the relevant Para of its reply filed earlier in this context that in pregnant women, the said testing Strategy V as well as those recommended by the ICMR in its earlier guidelines permits the Covid-19 testing under following conditions:
a) All symptomatic (Influenza Like Illness (ILI) symptoms) Pregnant women with history of international travel in the last 14 days.
b) All symptomatic (ILI symptoms) pregnant women with history of contact with a laboratory confirmed case of COVID-19.
c) All symptomatic (ILI symptoms) pregnant health care workers/ frontline workers involved in containment and mitigation of Covid-19.
d) All pregnant women with Severe Acute Respiratory Infection (SARI).
e) Asymptomatic direct and high risk pregnant women contact of a confirmed case to be tested once between day 5 and day 10 of coming into contact.
f) All symptomatic ILI pregnant women within hotspots / containment zones.
g) All hospitalized pregnant women who develop ILI symptoms.
h) All symptomatic ILI among pregnant women returnees and migrants within 7 days of illness.
i) All pregnant women that are planned for or may be potential candidates for procedure / interventions associated with aerosol generation.
8. It is reaffirmed and reiterated that as regard to admission in hospitals for in-patient care, interventions including surgery, including pregnant women coming for delivery etc., prior Covid-19 test is not mandatory and in emergent situations the treatment must not be denied for want of COVID-19 test results. The test may be conducted simultaneously as per ICMR testing strategy.
9. It is also submitted that with the availability of “Rapid Antigen Detection Testing”, pregnant women falling in any of the categories mentioned above can be tested in the health facility itself with the report being available within 30 minutes at the point of care.
10. In certain cases with a high index of suspicion, if the Rapid Antigen Detection Test comes out to be negative, the healthcare provider may go for RT PCR in which case the report will be available within 24 hrs (latest by 48 hrs.). In this case it is in the interest and benefit of both the patients & others (i.e. relatives, other patients in the hospital, medical & Para-medical personnel/ other hospital staff), that those awaiting test / test result be kept in separate ward as per the prescribed protocol and further steps are taken in accordance with the test results and this cannot be termed as discrimination.
11. While the admission, treatment or the required procedure is not denied and the testing undertaken simultaneously, the pregnant woman if found Positive on testing is ideally to be transferred to dedicated Covid-19 hospitals for further management once the immediate required care has been provided and she is stable and fit to be transferred.” (Emphasis supplied.)
8. In view of the stand taken by GNCTD in the aforesaid affidavit, we direct GNCTD to disseminate these guidelines to all hospitals, nursing homes and other healthcare providers which may be involved in providing care to pregnant women, specially during childbirth. It may be emphasised that, in accordance with t
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he stand taken by the respondents as aforesaid, admission to hospitals or other healthcare institutions with respect to obstetric management must not be denied or delayed for want of Covid-19 testing or to await its results. The result of the Rapid Antigen Detection Test, if performed, is usually available within 30 minutes. Even in the event an RT PCR test is required to be performed, GNCTD has stated that the report will be available within 24 hours [latest by 48 hours]. We note that the result of the RT PCR tests are normally available within 6 hours of testing, as stated by GNCTD in its affidavit dated 13.07.2020 relying upon the Advisory dated 23.06.2020 by ICMR. Having regard to the exigencies in which pregnant women normally approach the healthcare facilities, and the natural uncertainties when childbirth is imminent, it is further directed made clear that. if an RT-PCR test is required to be performed, the sample should be collected and the result must be available to the person within the period of 24 hours (or, in exceptional circumstances, 48 hours) from the time the person is referred for RT PCR testing. It is made clear that these are outer limits and all efforts must be made to collect the sample and obtain the result of the test within a shorter time, if possible. 9. With these observations, the writ petition is disposed of. The pending application also stands disposed of accordingly.