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DirectDetect SARS-CoV-2 qPCR Kit

Rapid qPCR detection of the SARS-CoV-2 virus in a SINGLE TUBE, with no need for RNA extraction

The DirectDetect™ SARS-CoV-2 qPCR Kit from Coyote Bioscience is a CE-marked, in vitro diagnostic real time reverse transcription PCR assay for the detection of SARS-CoV-2 nucleic acids in throat swabs from individuals suspected of COVID-19.

The kit uses innovative reagents and a and unique reaction program, to release the target nucleotides from specimens, and eliminate inhibitors, without an RNA extraction step. The kit detects the ORF1ab/N gene with internal controls. It uses rRT-PCR combined with fluorescence probes to detect the conserved region of ORF1ab and N gene of SARS-CoV-2, which are covered by a pair of specific primers and a fluorescence-labelled probe respectively.

Benefits of the DirectDetect SARS-Cov2 Detection Kit  
• Fast - 60 minutes from sample to result
• Scalable - 96 samples/run, 60 minutes/run, 2000+tests/24 hours
• Simple workflow - add sample and run the qPCR test directly
• Nucleic extraction and purification steps eliminated
• One tube reaction - minimises contamination
• High sensitivity and specificity

DirectDetect SARS-CoV-2 qPCR kit workflow

DirectDetect SARS-CoV-2 QPCR Kit process
1. The probe for the ORF 1ab gene of SARS-CoV-2 detection is labeled by FAM detector and BHQ quencher at the terminal ends of oligonucleotides.
2. ROX is the detector for the N gene.
3. If SARS-CoV-2 is present in the sample, the target sequence will be amplified and the fluorescence-labelled probe will be degraded by exonuclease activity of Taq DNA polymerase, resulting in a concomitant increase in fluorescent signal.
4. An internal control is a HEX labelled probe and a pair of primers using the RNase P gene of human as the target, to monitor the amplification effect of the detection system.
5. Works with swabs stored in VTM or UTM.

Detection significance

DirectDetect SARS-CoV-2 qPCR kit detection

Results are for the identification of SARS-CoV-2 RNA. Molecular diagnostic can detect the virus much earlier than antibody, using the RT-PCR method. Immunologic test, means we can detect a patient only 10 days after he is infected.

Interpretation of results
The SARS-CoV-2 RNA is generally detectable in throat swabs during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; Results are for the identification of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

No. FAM ROX HEX/VIC Target detection Result interpretation
1 + + +/- ORF1 lab positive: N gene positive Presumptive positive SARS-CoV-2
2 + - +/- ORF1 lab positive: N gene negative Repeat testing.
If repeat result is positive, it is presumptive positive SARS-CoV-2
3 - + +/- ORF1 lab negative: N gene positive Repeat testing.
If repeat result is positive, it is presumptive positive SARS-CoV-2
4 - - + ORF1 lab negative: N gene negative SARS-CoV-2 not detected
5 - - - Invalid Repeat testing.
If the repeated result remains invalid, consider collecting a new specimen from the patient

Note: "+" represents a positive result. "-" represents a negative result.
* The internal control can be positive or negative for cell cultures detection. The internal control should be positive for negative clinical specimen. Otherwise, the test is not credible and a new sample should be collected and tested.

Kit specificity
This kit shows no cross reactivity to human DNA or to any of the below pathogens:

Pathogens without kit cross reactivity
Flu B/Victoria Flu B/Yamataga Seasonal H1N1 influenza virus
H5N1 H7N9 New influenza A H1N1 virus (2009)
H3N2 Mycoplasma pneumoniae Respiratory syncytial virus type A
Adenovirus 3 Adenovirus 7 Respiratory syncytial virus type B
Chlamydia pneumoniae Chlamydia penumoniae Cytomegalovirus
CA16 Coronavirus 229E Coronavirus OC43
EV71 Coronavirus HKU1 Coronavirus NL63
HBoV-1 Parainfluenza virus PIV2 Partial pulmonary virus type A
Rhinovirus E.coli Legionella pneumophila
Streptococcus pneumoniae C. albicans Mycobacterium tuberculosis attenuated strain
Klebsiella pneumoniae Haemophilus influenzae Staphylococcus aureus


Patents
The DirectDetect technology has international PCT patents granted in US, Australia, and soon in Europe and many other countries.

Material available to download
DirectDetect SARS-CoV-2 qPCR Kit user manual
DirectDetect SARS-CoV-2 qPCR Kit CE certification

Products

Note: product availability depends on country - see product detail page.

Details Cat number & supplier Size Price
DirectDetect™ SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) 6018001902-EN · Coyote Bioscience
6018001902-EN
Coyote Bioscience
24 tests/kit £255.00
24 tests/kit
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DirectDetect™ SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) 6018001908-EN · Coyote Bioscience
6018001908-EN
Coyote Bioscience
96 tests/kit £999.00
96 tests/kit
view