Best Practices for Sample

Collection, Packaging,
Transportation, and
Testing

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What will I learn?

This document outlines the procedure for collection, packaging and transport of clinical specimens to public and private testing facilities

Learning Objectives Is this module for me ?

By the end of this lesson, you will learn: If you are carrying out any of the following
responsibilities, then this module is for you
• Who needs to be tested
• Identify persons to be tested for COVID-19
• How to collect, transport and store samples for testing
• Select private or public testing facility
• How to label and process samples
• Collect, store and/or transport samples
• Guidelines for testing and reporting
• Label, documentation and reporting
• The role of Rapid Antibody Kits in testing
• ANM, ASHA, AWW, Healthcare worker, NCC, NYK, NSS…

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What is your role in sample collection and testing?

Select Collect Transport

Clinician to decide necessity for Appropriate clinical sample By following all biosafety
collection of clinical need to be collected by precautions and using Personal
specimens for laboratory laboratory personnel/ health Protective Equipment (PPEs),
testing of COVID-19 only after care worker trained in specimen clinical samples need to be
following the case definition as collection in presence of a sent to the designated
given by the health authorities, clinician. laboratory by following
Government of India standard triple packaging

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Who needs to be tested?

All symptomatic individuals who have All symptomatic contacts of laboratory confirmed
undertaken international travel in the last cases
14 days

All hospitalized patients with Severe Acute Asymptomatic direct and high-risk contacts of
Respiratory Illness (fever and cough a confirmed case should be tested once between
and/or shortness of breath) day 5 and day 14 of coming in his/her contact

All symptomatic health care workers

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Two types of laboratories for COVD-19 testing

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Public
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ICMR
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For lab list Click here…
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Private Laboratory
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PCR assay
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Maximum cost for testing sample should not exceed Rs.
4,500 (include Rs. 1,500 for screening test for suspect
cases and additional Rs. 3,000 for confirmation test

ICMR encourages free or subsidized testing in this hour of National public health emergency
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Collection, packaging and transport of clinical specimens

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What is required for clinical sample collection, packaging & transport?

Sample vials and Absorbent material (cotton, tissue A leak-proof secondary container (e.g., ziplock pouch,
Virus Transport Medium (VTM) paper), paraffin, scissor, cello tape cryobox, 50 mL centrifuge tube, plastic container)

Hard-frozen Gel Packs A suitable outer container (e.g., thermocol box, ice-box, hard-board box)
(minimum dimensions: 10 x 10 x 10 cm)
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What sample/specimen needs to be collected? [1/2]
Specimen Type Collection Materials Temperature Temperature Comments
(Transport to laboratory) (Storage till testing) (if any)

The nasopharyngeal
and oropharyngeal
Dacron or
Nasopharyngeal and ≤5 days: 4 °C swabs should be
polyester flocked 4 °C
oropharyngeal swab >5 days: -70 °C placed in the same
swabs*
tube to increase the
viral load

There may be some

Bronchoalveolar ≤48 hours: 4 °C dilution of pathogen,
sterile container* 4 °C
lavage >48 hours: –70 °C but still a worthwhile
specimen

Tracheal aspirate,
nasopharyngeal ≤48 hours: 4 °C
sterile container* 4 °C
aspirate or nasal >48 hours: –70 °C
wash

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What sample/specimen needs to be collected? [2/2]
Specimen Type Collection Materials Temperature Temperature Comments
(Transport to laboratory) (Storage till testing)

Ensure the material is

≤48 hours: 4 °C
Sputum sterile container 4 °C from the lower
>48 hours: –70 °C
respiratory tract

Tissue from biopsy Autopsy sample

sterile container ≤24 hours: 4 °C
or autopsy including 4 °C collection preferably to
with saline >24 hours: –70 °C
from lung be avoided

Collect paired
Serum Serum separator samples:
(2 samples – tubes ≤5 days: 4 °C • acute – first week of
4 °C
acute and (adults: collect 3-5 ml >5 days: -70 °C illness
convalescent) whole blood) • convalescent – 2 to
3 weeks later
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Procedure to package and transport sample/specimen [1/3]

1 2

START…

Use Personal Protective Equipment Seal the neck of the sample vials
(PPE) while handling specimen using parafilm

4 3

Continued on
next page…

Arrange primary container (vial) in Cover the sample vials using

secondary container absorbent material
Note: Sample vials can also be placed inside a zip-lock pouch, covered in absorbent material and secured by heat- sealing
or rubber bands. Then, the zip-lock pouch should be placedPage 10
inside another plastic pouch and secured
Procedure to package and transport sample/specimen [2/3]

5 6

Continued from
previous page…

Place the centrifuge tube Place the zip-lock pouch inside a

inside a zip-lock pouch sturdy plastic container and seal the
neck of the container

8 7

Continued on
next page…

Use a hard card-board box as an outer Use a thermocol box as an outer container and
container and placing the secondary container place the secondary container within it, surrounded
and the gel packs Page 11 by hard- frozen gel packs
 Procedure to package and transport sample/specimen [3/3]

9 10 11

Continued from
previous page…

Place the completed Specimen Referral Form Secure the zip-lock pouch with the Attach the labels:

(available on www.niv.co.in) and request letter Specimen Referral Form on the • Senders’ address, contact number;

inside a leak-proof, zip-lock pouch outer container Consignee’s address /contact number;
• Biological substance- Category B;
• ‘UN 3373’; Orientation label, Handle
Documents to accompany: with care
• Packaging list/proforma Invoice
• Air way bill (for air transport) (to be prepared by sender or shipper)
• Value equivalence document (for road/rail/sea transport) END

Note: 1. A vaccine-carrier/ice-box can also be used as an outer container

2. The minimum dimensions of the outer container Page 12
should be 10 x 10 x 10 cm (length x width x height)]
Guidelines for testing & reporting for private laboratories

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Sample collection & testing guidelines for private laboratories [1/2]

Appropriate biosafety and biosecurity precautions should be ensured while collecting respiratory
samples (oropharyngeal and nasal swab) from a suspect patient. Alternatively, a COVID-19 specific
separate sample collection site may be created

Home collection of samples are preferable to avoid contact of people with suspect case during local
travel to reach the laboratory
Government ID to support current address and contact number of the suspect patient to be collected

Only real time PCR based assays are recommended. Conventional PCR, in-house, in-house PCR,
antibody/antigen tests are NOT recommended
Commercial kits for real time PCR based diagnosis should be US FDA approved or European CE
certified or both, under intimation to DCGI, MoH&FW.

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Sample collection & testing guidelines for private laboratories [2/2]

All laboratory staff involved in COVID-19 testing should be appropriately trained in Good Laboratory
Practices and performing real-time PCR

The sample should be opened only in Biosafety Cabinet Class II A2

All biomedical waste to be disposed off in accordance with National guidelines

Viral Transport Medium (VTM) with swabs should be discarded in a biohazard bag containing 2%
Lyzol or 5% freshly prepared hypochlorite solution
Bag should then be sealed using plastic tag and disposed off

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What are the reporting protocols for private laboratories? [1/2]

Immediate/real-time reporting
01 Test results with contact details to be reported to ICMR HQ
database https://cvstatus.icmr.gov.in
• All COVID-19 positive
samples to be transported to
ICMR-NIV under suitable
biosafety and biosecurity
Registration number
02 Login credentials to be given by ICMR. Registration number precautions
should prominently exhibited in advertisement and reports

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What are the reporting protocols for private laboratories? [2/2]

Contact tracing & control

03 Access to specified data and analysis to stakeholders like
IDSP/MoHFW will be provided through API for timely initiation
• Negative samples to be
destroyed within one week

Where to send the request ? • No sample should be shared

04 aggarwal.n@icmr.gov.in indicating name, contact details and with any other organization
mobile number of nodal contact for the lab for any purpose

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Role of Rapid Antibody Kits for COVID-19

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What is a Rapid antibody test kit ?

Rapid tests are designed for use where a preliminary screening test result is required and are
especially useful in resource-limited countries

High quality, easy-to- Quick and easy to perform

use tests for use in and require little or no
resource poor settings additional equipment.
Rapid

Same-day results Antibody Possibility to store at

Test Kit
provide timely treatment room temperature for
interventions extended period of time

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Source: https://www.who.int/diagnostics_laboratory/faq/simple_rapid_tests/en/
List of CE-IVD approved antibody based rapid kits [1/3]

1. COVID-19 IgM-IgG Dual Antibody Rapid Test (CE-IVD): BioMedomics (+1- 9198903070,

info@biomedomics.com, USA)

2. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold) (CE-IVD): Getein

Biotech (+86-25-68568594, sales@getein.com, overseas@getein.com.cn, Nanjing, China)

3. COVID 19 Rapid Test Kit (IgM/IgG) (CE-IVD) (Sensing Self Ltd, Singapore,), also validated by NIV, Pune

4. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (CE- IVD): Hangzhou Biotest

Biotech Co.,Ltd. (info@alltests.com.cn, +86-57- 158120625, China)

5. COVID-19 IgM/IgG test kit (CE-IVD) (AmonMed Biotechnology Co. Ltd, info@amonmed.com)

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List of CE-IVD approved antibody based rapid kits [2/3]

6. COVID-19 Antibody (IgG/IgM)Test Kit (CE-IVD) (Beijing Abace Biology Co., Ltd., huanyi.cheng@rd.abace-

biology.com)

7. Tigsun COVID-19 Combo IgM/IgG Rapid Test (CE-IVD) (Beijing Tigsun Diagnostics Co.,Ltd.,

hu.duan@tigsun.com)

8. 2019-nCoV IgG/IgM Rapid Test Cassette (CE-IVD) (BIOMAXIMA S.A, Poland, export@biomaxima.com)

9. OnSite COVID-19 IgG/IgM Rapid Test (CE-IVD) (CTK Biotech, Inc., USA, sparker@ctkbiotech.com)

10. COVID-19 IgG/IgM Detection Kit (Colloidal Gold) (CE-IVD) (Hunan Lituo Biotechnology Co., Ltd.,)

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 List of CE-IVD approved antibody based rapid kits [3/3]

8. VivaDiag SARS-CoV-2 IgM/IgG rapid test. (CE-IVD) Vivacheck Lab (91- 4448544811, info@vivacheck.com,

vivachek.india@gmail.com India office: Tamil Nadu)

9. COVID-19 Antibody Kit Serological Test. (CE-IVD) GenSure Biotech Inc., https://www.ozo.life (+91

7021901240, tarshant@ozo.life India Office: Bangalore

Antibody based rapid kit are validated by ICMR-NIV, Pune

1. SARS-CoV-2 Antibody Test: Wondfo (+86-3032296083, sales@wondfo.com.cn, China), validated by NIV,

Pune

Note: This is an evolving list, and kits which will getPage

CE/FDA
22 approval or validated by NIV Pune will be added.
 What are the advantages and disadvantages of Rapid Antibody Kits ?

• Can be done on blood/serum/plasma samples • Test comes positive after 7-10 days of infection

• Test result is available within 30 minutes • The test remains positive for several weeks after infection

• Positive test indicates exposure to SARS-CoV-2 • Negative test does not rule out COVID-19 infection

Note: These tests are not recommended

Page 23 for diagnosis of COVID-19 infection
Key points to remember…

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Here are a few key points to remember from this module

• Personal Protective Equipment (PPE, e.g. apron, hand gloves, face shield, N95 Masks etc.) need to be used

• All biosafety precautions should be followed so as to protect individuals and the environment.

• Proper labelling (name/age/gender/specimen ID) need to be done on specimen container

• Other details of sender (name/address/phone number) on the outer container by mentioning “To

be tested for 2019-nCoV”

• Clinical specimens, official documents and Specimen request forms for testing of 2019-nCoV

need to be sent to the ICMR-NIV address (The Director, ICMR-National Institute of Virology, 20-A, Dr

Ambedkar Road, Pune, Maharashtra, Pin: 4110001).

For further details view the webinar by clicking on the icon or the link…
https://www.youtube.com/watch?v=BTLGGV3_XnI
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• For any queries, the nodal officer from ICMR-NIV Pune (Dr Yogesh K. Gurav, Scientist E) may be contacted
(Phone 020-26006290/ 26006390; Email: gurav.yk@gmail.com/gurav.yk@gov.in) and need to be informed
in advance before sending specimens to ICMR-NIV, Pune
x4

• For shipment-related queries/information, kindly contact Dr Sumit Bharadwaj (Scientist B, Influenza Group)
on email: sumitduttbhardwaj@gmail.com, phone 020-26006290/26006390

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Glossary [1/2]

Asymptomatic: presenting no symptoms of disease. In the case of COVID-19, this means absence of fever, dry cough, sore throat, shortness of breath and body
aches, among other less common symptoms. Notably, it is recommended that individuals do not get tested unless they exhibit symptoms because of the risk of
false negatives. In other words, most tests will not be accurate unless symptoms are present.

Community spread: the spread of a contagious disease in a geographic area in which there is no knowledge of how someone contracted the disease. In other
words, no known contact can be traced to other infected individuals.

Confirmed positive case: in contrast to a presumptive positive case, this is confirmation from ICMR-NIV of a positive COVID-19 test in an individual.

Contact tracing: identifying and monitoring people who may have come into contact with an infectious person. In the case of COVID-19, monitoring usually
involves self-quarantine as an effort to control the spread of disease.

Coronavirus: a family of viruses that include SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) as well as other
respiratory illnesses. A coronaviruses, also known as a CoV, is typically spread between animals and humans—an event known as zoonotic transfer—and they
are named for the term “corona”—Latin for crown—which refers to the shape of the virus when observed microscopically.

COVID-19: COVID-19 stands for novel coronavirus disease 2019, which refers to the year of its initial detection. COVID-19 is the illness related to the current
pandemic; the illness is caused by the virus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

National emergency: a state of emergency resulting from the global threat of the pandemic. On March 13, 2020, President Trump issued a national emergency
concerning the COVID-19 outbreak, which allowed for loosened restrictions on tele-health as well as certain requirements for hospitals and health care providers
to allow them to respond to the crisis.

Novel coronavirus: a new strain of coronavirus, or nCoV, that has never been detected in humans.

SARS-CoV2: the virus fully defined as “severe acute respiratory syndrome coronavirus 2” causes the disease COVID-19.

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Glossary [2/2]

NABL: National Accreditation Board for Testing and Calibration Laboratories

PPE: personal protective equipment, or PPE, is specialized clothing and equipment used as a safeguard against health hazards including exposure to infectious
diseases through physical contact or airborne particles. PPE is designed to protect parts of the body typically exposed in normal attire, including the nose,
mouth, eyes, hands and feet. Notably, N95 respirators are considered ideal for health care workers who may be exposed to SARS-CoV-2.

PCR: Polymerase chain reaction (PCR) is a method widely used in molecular biology to rapidly make millions to billions of copies of a specific DNA sample
allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.

RNA: Ribonucleic acid (RNA) is a polymeric molecule essential in various biological roles in coding, decoding, regulation and expression of genes

Symptomatic: showing symptoms of COVID-19, which can include a fever, dry cough, shortness of breath and body aches. Health officials believe the risk of
transmitting the virus is highest when an individual is symptomatic.

Vaccine: a biological preparation of organisms that provides immunity to a particular infectious disease. Currently, there is no vaccine for COVID-19.

Ventilator: a machine designed to move air in and out of the lungs for a patient who is physically unable to breathe or who is not breathing well. Because
COVID-19 can cause severe lower respiratory infection, ventilators are a critical machine for patients with severe disease

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