Diagnostic kit for CoV-2 Nucleic Acid
    Publish time 1970-01-01 08:00    
CoV-2 Nucleic Acid (Real-time PCR)
CE and WHO approved 
[PRODUCT NAME]
Diagnostic kit for SARS-CoV-2 Nucleic Acid (Real-time PCR)
[PACKING SPECIFICATIONS]
48T/Kit
[INTENDED USE]
The test is used for the qualitative detection of SARS-CoV-2 nucleic acid by
targeting ORF1ab region, N and E proteins genes of the viral genome. The result
is for assisting the clinical diagnosis and should not be used as the sole basis for
treatment.
[PRINCIPLE OF TEST]
The 3 target sequences for the test are in ORF1ab region, in N and E protein genes
of the SARS-CoV-2 genome. Specific primers were designed to amplify highly
conservative segments of these 3 regions. Specific labeled probes were designed to
hybridize to the amplicons, during the PCR extension step, 5’exonuclease activity
of Taq polymerase cuts 5’ end fluorophore from the probe, making it free in
reaction system, so as to separate from the shielding of 3’ end fluorescent quencher,
which enables it to accept photo-stimulation to emit fluorescence that can be
detected with instruments, so as to detect SARS-CoV-2 nucleic acid automatically
in a fully closed reaction system.
Internal control (IC) is designed with a region from a housekeeping gene (beta
actin). Amplification of targets and IC takes place simultaneously in the same
reaction. The IC is used for monitoring that the process has proceeded correctly for
each sample.
Component
Specifications
Main compositions
SARS-CoV-2 Reagent A
300μl ×1
Buffer, dNTPs, Mg2+
SARS-CoV-2 Reagent B
400μl × 1
Taq polymerase, RNasin, Reverse
transcriptase, UNGase
SARS-CoV-2 Reagent C
300μl × 1
Primers and probes
SARS-CoV-2 Positive control
3ml × 1
Armored RNA of ORF1ab/N/E targets
SARS-CoV-2 Negative control
3ml × 1
Storage buffer
Notes: Kit components of different lot numbers are not interchangeable.
[STORAGE CONDITIONS AND SHELF LIFE]
The kit must be stored at -15°C or colder when not in use and keep away from the
light. It has a shelf life of 12 months, and required to be used within the validity
period.
[APPLICABLE INSTRUMENTS]
Fluorescent real-time PCR instruments with at least four detection channels (FAM,
VIC /HEX, ROX/TEXAS RED, Cy5) such as ABI7500, Bio-Rad CFX96, Tianlong
Gentier 96E, etc.
[SPECIMENS COLLECTION AND STORAGE REQUIREMENTS]
1. Specimens type: human nasopharyngeal swab, sputum, lower respiratory tract
specimens (tracheal secretions, endotracheal aspirate, alveolar lavage fluid),
blood
2. Pretreatment:
1) Human nasopharyngeal swab and Alveolar lavage fluid: Add 1ml of sterile
normal saline into the specimen tube (thaw the frozen specimen at room
temperature and mix it well before use), shake it well.
2) Sputum: add 4 times volume of 4% NaOH into the sputum, mix well, place it
at room temperature for 60 minutes to make it fully liquefied, take 0.5ml of
liquefied sample into EP tube, add 0.5ml of 4% NaOH then leave it at room
temperature for 10 minutes, centrifugation at 13000rpm × 10 minutes, and 3
discard the supernatant; add 1ml of physiological saline into the sediment, shake
well and reserve.
3) Blood sample: centrifugation, obtaining serum or plasma.
3. Sample collection: please refer to the Manual of Microbial Specimen Collection
for specific sample collection method.
4. Sample Storage: kept at 2-8°C for no more than 7h, kept below -15°C for no
more than 3 months, long-term storage if kept below -70°C, but repeated freeze
thaw cycles should be avoided.

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