ICMR Advises States to Halt Use of Rapid Test Kits for Two Days

The Indian Council of Medical Research (ICMR), India’s apex body for biomedical research, issued an advisory instructing all states and Union Territories to temporarily halt the use of COVID-19 rapid antibody test kits for two days due to wide variations in their results. This decision was taken to allow the ICMR to re-evaluate the reliability and accuracy of the testing kits after inconsistencies were reported from several states.

Background and Context

During the early months of the COVID-19 pandemic, India adopted a multi-layered testing strategy to identify infections efficiently. The RT-PCR (Reverse Transcription Polymerase Chain Reaction) test was established as the gold standard for detecting the presence of the virus, while rapid antibody test kits were introduced as a supplementary tool to detect antibodies indicating past exposure to the virus.
These rapid test kits, developed by various global manufacturers and imported by India, were distributed across states to enhance surveillance and assist in large-scale screening, particularly in hotspot regions. However, as the tests were rolled out, many states, including Rajasthan, Maharashtra, and West Bengal, reported inconsistent and unreliable results, raising concerns over the kits’ accuracy.

Reason for the Advisory

The ICMR issued the advisory after several states reported that the rapid test kits were showing significant discrepancies when compared to RT-PCR test results. Some kits exhibited low sensitivity and specificity, leading to false negatives or false positives.
Key reasons for halting the use of these kits included:

• Inconsistent Results: Wide variations in performance across different regions and conditions were observed.
• Quality Assessment: The need to verify whether inconsistencies were due to faulty kits, storage issues, or testing procedures.
• Validation Studies: ICMR’s own evaluation teams needed time to re-assess and revalidate the performance of the kits under controlled laboratory conditions.

The halt was announced for two days to enable experts to conduct thorough cross-verification and quality checks on the testing kits.

The Nature of Rapid Test Kits

Rapid antibody test kits are designed to detect IgM and IgG antibodies produced by the body in response to SARS-CoV-2 infection. These antibodies generally develop after 7–10 days of infection, meaning that such tests are useful for epidemiological surveillance rather than for diagnosing active infection.
The advantages of these tests include quick results (within 15–30 minutes) and easy application in field settings. However, their reliability depends on precise calibration, environmental conditions, and the timing of the test relative to infection onset.

Actions Taken by ICMR

Following reports of discrepancies, the ICMR took several steps:

1. Suspension of Use: Advised all states to stop using the kits for at least two days while fresh validation tests were conducted.
2. Re-evaluation: Conducted assessments at national laboratories, including the National Institute of Virology (NIV), Pune, to evaluate kit sensitivity and specificity.
3. Communication with Suppliers: Contacted the manufacturers and importers of the faulty kits to seek clarification and performance documentation.
4. Revised Guidelines: Planned to issue updated instructions for the storage, handling, and use of kits once reliability was confirmed.
5. Alternative Testing Strategy: Encouraged states to continue using RT-PCR testing, the most accurate method for active case detection, until antibody kit issues were resolved.

States Reporting Issues

Several states raised concerns about the kits before the ICMR advisory:

• Rajasthan reported that nearly 5% accuracy variation was observed, making the kits unreliable.
• West Bengal stated that results from rapid tests were inconsistent and sometimes contradictory to RT-PCR findings.
• Madhya Pradesh and Maharashtra also highlighted operational challenges, citing unreliable readings under field conditions.

These collective reports prompted ICMR’s decision to suspend testing temporarily and undertake a quality reassessment.

Clarification by ICMR

The ICMR clarified that the rapid antibody test was not intended to diagnose active COVID-19 cases but was meant to be used for sero-surveillance—to estimate the spread of infection in a community. The Council emphasised that RT-PCR testing remained the only confirmatory test for COVID-19 infection.
The temporary halt, therefore, was not a withdrawal of the testing method but a precautionary step to ensure accuracy and public trust in testing mechanisms.

Importance of Quality Control in Diagnostics

The episode highlighted the critical importance of stringent quality control and validation in diagnostic tools, especially during pandemics. Rapid deployment of unverified kits can lead to misdiagnosis, poor surveillance data, and misallocation of healthcare resources.
The ICMR’s decision reflected a cautious, science-based approach prioritising reliability over speed, ensuring that public health decisions are based on credible and accurate data.

Subsequent Developments

Following the two-day suspension, the ICMR completed its evaluation and found that some imported kits underperformed in Indian conditions. These kits were subsequently withdrawn or replaced with more reliable alternatives from other approved manufacturers. The experience led to:

• Strengthening of validation protocols for all imported diagnostic tools.
• Encouragement of indigenous development of reliable testing kits under the Make in India initiative.
• Implementation of a centralised testing validation mechanism for all COVID-19 diagnostic equipment before state-level distribution.

Significance of the Decision

The advisory served as a reminder of the need for scientific validation and standardisation in public health tools. It also underscored India’s growing institutional capacity to monitor, evaluate, and regulate large-scale testing mechanisms swiftly and effectively.
By taking corrective measures early, the ICMR ensured that national testing efforts maintained credibility, accuracy, and efficiency, contributing to the broader goal of controlling the pandemic through evidence-based strategies.